Radiesse Volume Advantage 8071M0K2Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI M2138071M0K25), received between Jul 3, 2019 and Sep 29, 2026 — classified as 26 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (4 reports).

3 other recalls cover devices cleared under the same FDA submission (P050037, P050052); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Off-Label Use; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 50933193 ↗
• InjuryAug 3, 2026Off-Label Use; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  Case Description: This case was linked with case (b)(4), referring to the same patient.This spontaneous report was received from a US healthcare professional and concerns a 69-year-old female patient. The patient was injected with a total of 13 syringes of Radiesse, into the abdomen, knees, thighs, neck, arms (Off label use of device) and face, on (b)(6)-2026. Batch number was reported as (b)(6) (expiry date: 21-Apr-2029). The batch record review was received and the lot number for Radiesse was confirmed as (b)(6) (expiry date: 21-Apr-2029). A lot search in the global safety database was conducted. Radiesse was hyperdiluted (reported as HDR) for the injection into the face, abdomen, arms, knees and thighs. A hybrid of hyperdiluted Radiesse, Belotero Balance US and Xeomin (reported as hybrid Gold) (Product preparation issue, Off label use of device) was used for the neck injection. The patient had bug bites before the injection, which she noticed in (b)(6) 2026, 2-3 days before the Radiesse injection. The affected tissue to right chin was avoided during the Radiesse injection.In (b)(6) 2026, reported as days after the Radiesse injection, the patient experienced lesions/Pseudomonas i

  Patient problems: Bacterial Infection; Foreign Body Reaction; No Clinical Signs, Symptoms or Conditions; Pain; Scar Tissue

  MAUDE report 50114301 ↗
• InjuryDec 31, 2025Off-Label Use; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  CASE DESCRIPTION: THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US HEALTH CARE PROFESSIONAL AND CONCERNS A PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE. AFTER THE RADIESSE INJECTION, THE PATIENT EXPERIENCED AN OCCLUSION. THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 28-DEC-2025: THE EVENT TERM OCCLUSION WAS RENAMED TO OCCLUSION OF THE LEFT TRANSVERSE FACIAL ARTERY AND THE CODING REMAINED UNCHANGED. THE PATIENTS' INITIALS, DATE OF BIRTH, AGE, AND GENDER (FEMALE) WERE PROVIDED. THE PATIENT WAS 41 YEARS OLD AT THE TIME OF THE EVENT. THE PATIENT WAS INJECTED SUBCUTANEOUSLY WITH A TOTAL OF 2 ML OF RADIESSE, INTO THE TEMPLES, ZYGOMA, PRE-AURICULAR (REPORTED AS PRE-AURRIC), JAWLINE (OFF LABEL USE OF DEVICE), AND NASOLABIAL FOLDS, ON (B)(6) 2025. BATCH NUMBER WAS REPORTED AS A00151100 (EXPIRY DATE 15-MAY-2027). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE WAS CONFIRMED AS A00151100 (EXPIRY DATE 15-MAY-2027). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. TWO SYRINGES OF RADIESSE WERE DILUTED WITH 1.5 ML BACTERIOSTATIC NORMAL SALINE (REPORTED AS BNS), (PRODUCT PREPARATION ISSUE, OFF LABEL USE OF DEVICE) EACH IN A 1:1 RATIO AN

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 23933418 ↗
• InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US HEALTH CARE PROFESSIONAL AND CONCERNS A FEMALE PATIENT. SHE WAS INJECTED WITH 1 SYRINGE OF RADIESSE(+), INTO THE NECK (OFF LABEL USE OF DEVICE), MORE THAN A MONTH PRIOR TO THE TIME OF THIS REPORT, IN 2024. RADIESSE(+) WAS DILUTED (PRODUCT PREPARATION ISSUE), IN A 1:3 DILUTION. IN 2024, AFTER THE RADIESSE(+) INJECTION, THE PATIENT EXPERIENCED NODULES IN THE NECK. CORRECTIVE TREATMENT INCLUDED INTERVENTION WITH STERILE WATER, MICRONEEDLING AND SUBCISION MULTIPLE TIMES, BUT THE NODULES WERE NOT RESOLVED. THE OUTCOME OF THE EVENT WAS REPORTE AS NOT RESOLVED. FOLLOW UP INFORMATION WAS RECEIVED ON 16-MAY-2024: THIS CASE WAS UPGRADED TO SERIOUS. THE SUSPECT PRODUCT WAS RECODED FROM RADIESSE(+) TO RADIESSE. PRODUCT PREPARATION ISSUE WAS DELETED AS THE PATIENT WAS INJECTED WITH DILUTED RADIESSE, NOT DILUTED RADIESSE(+). THE PATIENTS INITIALS, DATE OF BIRTH (1986), AND AGE WERE PROVIDED. SHE WAS 36 YEARS OLD AT THE TIME OF THE EVENT (AMBIGUOUSLY REPORTED AS 37). THE PATIENT WAS INJECTED WITH RADIESSE ON (B)(6) 2022. BATCH NUMBER WAS REPORTED AS A00060820 (EXPIRY DATE: 06/2025). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE

  Patient problems: Nodule

  MAUDE report 19487377 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US HEALTH CARE PROFESSIONAL AND CONCERNS A FEMALE PATIENT. SHE WAS INJECTED WITH RADIESSE. BATCH NUMBER WAS AMBIGUOUSLY REPORTED AS A000100370 (EXPIRY DATE: 02/2026). AFTER THE RADIESSE INJECTION, THE PATIENT EXPERIENCED A VASCULAR OCCLUSION TO THE LEFT CHEEK. THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 14-NOV-2023: THE BATCH NUMBER WAS CONFIRMED AS A00100370 (EXPIRY DATE: 02/2026). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE WAS CONFIRMED AS A00100370 (EXPIRY DATE: 02/2026). THE OUTCOME OF THE EVENT REMAINED UNCHANGED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18172899 ↗
• InjurySep 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US PHYSICIAN AND CONCERNS A FEMALE PATIENT. SHE WAS INJECTED WITH PERIOSTEUM DEPOTS OF RADIESSE, INTO THE RIGHT MANDIBLE (OFF LABEL USE OF DEVICE). BATCH NUMBER WAS REPORTED AS UNKNOWN. A FEW HOURS AFTER THE RADIESSE INJECTIONS ON THE PERIOSTEUM, THE PATIENT EXPERIENCED AN ACUTE PAIN AND MARKED SWELLING WITH SOME OVERLYING SKIN DUSKINESS ON THE RIGHT MANDIBULAR AREA. IT APPEARED CONSISTENT WITH A VASCULAR OCCLUSION (REPORTED AS VO). THE PATIENT WAS TREATED WITH 300 UNITS OF HYALURONIDASE TO SITE ON POSTOPERATIVE DAY 0 (REPORTED AS POD 0). THEN REPEAT TREATMENT ON POSTOPERATIVE DAY 1 (REPORTED AS POD 1) . DUE TO PERSISTENT PAIN, AS WELL AS NITROGLYCERIN PASTE, BABY ASPIRIN AND ORAL DOXYCYCLINE. THE OUTCOME OF THE EVENTS WAS UNKNOWN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17765256 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US PHYSICIAN AND CONCERNS A 55-YEAR-OLD FEMALE PATIENT. SHE WAS INJECTED WITH RADIESSE, INTO THE MID-FACE AND PERIORAL (OFF LABEL USE OF DEVICE), FOR RHYTIDS, VOLUME LOSS AND ASYMMETRY, ON (B)(6) 2023. BATCH NUMBER WAS REPORTED AS A00080750 (EXPIRY DATE: 07/2025). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE WAS CONFIRMED AS A00080750 (EXPIRY DATE: 07/2025). AS REPORTED SHE WAS INJECTED WITH (B)(4) UNITS OF RADIESSE. SHE WAS CONCOMITANTLY INJECTED WITH ONE VIAL OF BELOTERO BALANCE LIDOCAINE, INTO THE MID-FACE AND PERIORAL, FOR RHYTIDS, VOLUME LOSS AND ASYMMETRY, ON (B)(6) 2023. BATCH NUMBER WAS REPORTED AS E00002280 (EXPIRY DATE: 12/2023). THE PATIENTS MEDICAL HISTORY AND CONCOMITANT MEDICATION WERE REPORTED AS NONE. ON (B)(6) 2023, 1 DAY AFTER THE RADIESSE INJECTION, THE PATIENT EXPERIENCED A VERY SEVERE CELLULITIS. ON (B)(6) 2023, THE REPORTER SAW THE PATIENT AND SHE STARTED THE TREATMENT WITH AUGMENTIN. ON (B)(6) 2023, SHE WAS ADMITTED FOR INTRAVENOUS ANTIBIOTICS FOR SEVERAL DAYS. THE PATIENT STATED CULTURE FROM AFFECTED SKIN WAS PERFORMED AND SHOWED STREP. THE INFECTION RESOLVED. ON (B)(6) 2023, THE REPORTER SA

  Patient problems: Cellulitis

  MAUDE report 17712747 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR IS RELATED TO MDRS 3013840437-2023-00094, 3013840437-2023-00095, AND 3013840437-2023-00096, REFERRING TO THE SAME PATIENT. THIS CASE WAS LINKED TO LSSMV CASE NUMBERS (B)(4), REFERRING TO THE SAME REPORTER AND SAME PATIENT, AND TO CASE NUMBER 23-02723 REFERRING TO THE SAME REPORTER. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US PHYSICIAN AND CONCERNS A FEMALE PATIENT. SHE WAS INJECTED WITH RADIESSE. THE PHYSICIAN CONTACTED WITH THE PATIENT RECENTLY PRIOR TO THIS REPORT WHO MOVED IN 2020. SHE WAS INJECTED BEFORE SHE MOVED. AFTER THE RADIESSE INJECTION, THE PATIENT WAS EXPERIENCING A DELAYED ALLERGIC REACTION. SHE WAS WORKING WITH A PLASTIC SURGEON WHO WAS DEALING WITH MORE THAN HER CASE ALONE (AS REPORTED). THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 17-AUG-2023: THIS CASE WAS UPGRADED TO SERIOUS. THE EVENTS MIGRATION, SCARRING AND CALCIFICATION, OFF LABEL USE AND PRODUCT PREPARATION ISSUE WERE ADDED. THE VERBATIM DELAYED ALLERGIC REACTION WAS AMENDED TO DELAYED ALLERGIC REACTION/IMMUNE MEDIATED DELAYED HYPERSENSITIVITY, CODING REMAINS UNCHANGED. THE LINKING SENTENCE WAS ADDED. THE PATIENTS INITIALS, AGE AND DATE OF BIRTH WERE PROVIDED. SHE W

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 17674097 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR IS RELATED TO MDRS 3013840437-2023-00094, 3013840437-2023-00095, AND 3013840437-2023-00097, REFERRING TO THE SAME PATIENT. THIS CASE WAS LINKED TO LSSMV CASE NUMBERS (B)(4), REFERRING TO THE SAME REPORTER AND SAME PATIENT, AND TO CASE NUMBER (B)(4) REFERRING TO THE SAME REPORTER. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US PHYSICIAN AND CONCERNS A FEMALE PATIENT. SHE WAS INJECTED WITH RADIESSE. THE PHYSICIAN CONTACTED WITH THE PATIENT RECENTLY PRIOR TO THIS REPORT WHO MOVED IN 2020. SHE WAS INJECTED BEFORE SHE MOVED. AFTER THE RADIESSE INJECTION, THE PATIENT WAS EXPERIENCING A DELAYED ALLERGIC REACTION. SHE WAS WORKING WITH A PLASTIC SURGEON WHO WAS DEALING WITH MORE THAN HER CASE ALONE (AS REPORTED). THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 17-AUG-2023: THIS CASE WAS UPGRADED TO SERIOUS. THE EVENTS MIGRATION, SCARRING AND CALCIFICATION, OFF LABEL USE AND PRODUCT PREPARATION ISSUE WERE ADDED. THE VERBATIM DELAYED ALLERGIC REACTION WAS AMENDED TO DELAYED ALLERGIC REACTION/IMMUNE MEDIATED DELAYED HYPERSENSITIVITY, CODING REMAINS UNCHANGED. THE LINKING SENTENCE WAS ADDED. THE PATIENTS INITIALS, AGE AND DATE OF BIRTH WERE PROVIDED. SHE WAS

  Patient problems: Scar Tissue

  MAUDE report 17673991 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR IS RELATED TO MDRS 3013840437-2023-00094, 3013840437-2023-00096, AND 3013840437-2023-00097, REFERRING TO THE SAME PATIENT. THIS CASE WAS LINKED TO LSSMV CASE NUMBERS (B)(4) AND (B)(4), REFERRING TO THE SAME REPORTER AND SAME PATIENT, AND TO CASE NUMBER (B)(4) REFERRING TO THE SAME REPORTER. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US PHYSICIAN AND CONCERNS A FEMALE PATIENT. SHE WAS INJECTED WITH RADIESSE. THE PHYSICIAN CONTACTED WITH THE PATIENT RECENTLY PRIOR TO THIS REPORT WHO MOVED IN 2020. SHE WAS INJECTED BEFORE SHE MOVED. AFTER THE RADIESSE INJECTION, THE PATIENT WAS EXPERIENCING A DELAYED ALLERGIC REACTION. SHE WAS WORKING WITH A PLASTIC SURGEON WHO WAS DEALING WITH MORE THAN HER CASE ALONE (AS REPORTED). THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 17-AUG-2023: THIS CASE WAS UPGRADED TO SERIOUS. THE EVENTS MIGRATION, SCARRING AND CALCIFICATION, OFF LABEL USE AND PRODUCT PREPARATION ISSUE WERE ADDED. THE VERBATIM DELAYED ALLERGIC REACTION WAS AMENDED TO DELAYED ALLERGIC REACTION/IMMUNE MEDIATED DELAYED HYPERSENSITIVITY, CODING REMAINS UNCHANGED. THE LINKING SENTENCE WAS ADDED. THE PATIENTS INITIALS, AGE AND DATE OF BIRTH WERE PROVID

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17673877 ↗
• InjurySep 1, 2023Off-Label Use; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Migration; Off-Label Use; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Migration

  THIS MDR IS RELATED TO MDRS 3013840437-2023-00095, 3013840437-2023-00096, AND 3013840437-2023-00097, REFERRING TO THE SAME PATIENT. THIS CASE WAS LINKED TO LSSMV CASE NUMBERS (B)(4) AND (B)(4), REFERRING TO THE SAME REPORTER AND SAME PATIENT, AND TO CASE NUMBER (B)(4) REFERRING TO THE SAME REPORTER. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US PHYSICIAN AND CONCERNS A FEMALE PATIENT. SHE WAS INJECTED WITH RADIESSE. THE PHYSICIAN CONTACTED WITH THE PATIENT RECENTLY PRIOR TO THIS REPORT WHO MOVED IN 2020. SHE WAS INJECTED BEFORE SHE MOVED. AFTER THE RADIESSE INJECTION, THE PATIENT WAS EXPERIENCING A DELAYED ALLERGIC REACTION. SHE WAS WORKING WITH A PLASTIC SURGEON WHO WAS DEALING WITH MORE THAN HER CASE ALONE (AS REPORTED). THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 17-AUG-2023: THIS CASE WAS UPGRADED TO SERIOUS. THE EVENTS MIGRATION, SCARRING AND CALCIFICATION, OFF LABEL USE AND PRODUCT PREPARATION ISSUE WERE ADDED. THE VERBATIM DELAYED ALLERGIC REACTION WAS AMENDED TO DELAYED ALLERGIC REACTION/IMMUNE MEDIATED DELAYED HYPERSENSITIVITY, CODING REMAINS UNCHANGED. THE LINKING SENTENCE WAS ADDED. THE PATIENTS INITIALS, AGE AND DATE OF BIRTH WERE PROVID

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Calcium Deposits/Calcification; Fungal Infection; Hair Loss; Local Reaction; No Clinical Signs, Symptoms or Conditions; Scar Tissue

  MAUDE report 17673785 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US PHYSICIAN AND CONCERNS A PATIENT. THE PATIENT WAS INJECTED, WITH RADIESSE, INTO THE JAWLINE AND CHEEKS (OFF LABEL USE OF DEVICE). MONTHS AFTER THE TREATMENT WITH RADIESSE, THE PATIENT EXPERIENCED DELAYED NODULES UNDER THE SKIN. THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 14-MAR-2023: THE CASE WAS UPGRADED TO SERIOUS. THE EVENT TERM DELAYED NODULES WAS CHANGED TO FOREIGN BODY GRANULOMA. THE CODING WAS CHANGED FROM INJECTION SITE NODULE TO INJECTION SITE GRANULOMA. THE PATIENTS INITIALS, AGE AND DATE OF BIRTH WERE PROVIDED. THE PATIENT WAS 60 YEARS OLD AT THE TIME OF THE EVENT. THE PATIENT WAS INJECTED WITH A TOTAL OF 1.5 ML OF RADIESSE, ON (B)(6) 2022. BATCH NUMBER WAS REPORTED AS A00066640. A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE WAS CONFIRMED AS A00066640 (EXPIRY DATE: 07/2025). THE PATIENT HAD NO PREVIOUS FILLER TREATMENTS. THE PATIENT HAD NO RELEVANT MEDICAL HISTORY OR CONCOMITANT MEDICATION. IN DECEMBER 2022, AFTER THE TREATMENT WITH RADIESSE, THE PATIENT EXPERIENCED DELAYED NODULES UNDER THE SKIN. ON (B)(6) 2023,

  Patient problems: Granuloma

  MAUDE report 16644706 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOW-UP INFORMATION WAS RECEIVED ON 17-APR-2023: THE LINKING SENTENCE WAS ADDED TO THE TOP OF THE NARRATIVE. THE SUSPECT PRODUCT WAS RECODED FROM RADIESSE(+) TO RADIESSE. THE EVENT ACUTE INFLAMMATORY REACTION WAS ADDED. THE EVENT TERM POSSIBLE OCCLUSION WAS AMENDED TO VASCULAR OCCLUSION AND THE CODING REMAINED UNCHANGED. THE PATIENTS GENDER (MALE), INITIALS, DATE OF BIRTH AND AGE WERE PROVIDED. HE WAS 65 YEARS OLD AT THE TIME OF THE EVENT. THE PATIENT WAS INJECTED WITH RADIESSE. BATCH NUMBER WAS REPORTED AS 100131227 (EXPIRY DATE: 07/2023). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE WAS CONFIRMED AS 100131227 (EXPIRY DATE: 07/2023). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. THE PATIENT WAS PREVIOUSLY INJECTED WITH RADIESSE, INTO THE CHEEKS, A FEW YEARS PRIOR TO THIS REPORT. HE HAD NO ADVERSE EVENTS. THE PATIENTS MEDICAL HISTORY INCLUDED NO MAJOR ILLNESSES. HE WAS ALREADY TAKING ASPIRIN FOR PROPHYLACTIC PURPOSES. ON (B)(6) 2023, AFTER THE RADIESSE INJECTION, THE PATIENT EXPERIENCED SOME SWELLING ON RIGHT CHEEK. SOME ACUTE INFLAMMATORY REACTION VERSUS VASCULAR OCCLUSION WAS CONSIDERED. ON (B)(6) 2023, THE PATENT WAS TOLD TO FOLLOW UP AND ST

  Patient problems: Obstruction/Occlusion

  MAUDE report 16643366 ↗
• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR IS RELATED TO MDR 3013840437-2023-00015 REFERRING TO THE SAME PATIENT. THIS SPONTANEOUS REPORT WAS RECEIVED FROM AN US NURSE AND CONCERNS A PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE. THE BATCH NUMBER WAS REPORTED AS A00053290 (EXPIRY DATE: 03/2025). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE WAS CONFIRMED AS A00053290 (EXPIRY DATE: 03/2025). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. MORE THAN 3 MONTHS AFTER THE RADIESSE INJECTION, THE PATIENT EXPERIENCED A SOFT LUMP IN THE NECK. THE PATIENT BELIEVED THAT THE AESTHETIC INJECTION WAS THE CAUSE. ABOUT 3 MONTHS AFTER THE RADIESSE INJECTION, THE PATIENT DEVELOPED TORTUOUS BLOOD VESSELS/VARICOSITIES. THE OUTCOME OF THE EVENTS WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON (B)(6) 2023: THIS CASE WAS UPGRADED TO SERIOUS. THE EVENT TERM SOFT LUMP IN NECK WAS AMENDED TO SOFT LUMP IN NECK/ HYPODENSE RIGHT THYROID NODULE, CODING REMAINS UNCHANGED. EXPECTEDNESS FOR THE EVENT TORTUOUS BLOOD VESSELS/VARICOSITIES WAS REASSESSED. THE PATIENTS INITIALS, DATE OF BIRTH, AGE AND WEIGHT (58.9 KG) WERE PROVIDED. THE PATIENT WAS 51 YEARS OLD AT THE TIME OF THE EVENTS. THE PATIENT WAS INJECTED WI

  Patient problems: Nodule

  MAUDE report 16430046 ↗
• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR IS RELATED TO MDR 3013840437-2023-00016 REFERRING TO THE SAME PATIENT. THIS SPONTANEOUS REPORT WAS RECEIVED FROM AN US NURSE AND CONCERNS A PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE. THE BATCH NUMBER WAS REPORTED AS A00053290 (EXPIRY DATE: 03/2025). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE WAS CONFIRMED AS A00053290 (EXPIRY DATE: 03/2025). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. MORE THAN 3 MONTHS AFTER THE RADIESSE INJECTION, THE PATIENT EXPERIENCED A SOFT LUMP IN THE NECK. THE PATIENT BELIEVED THAT THE AESTHETIC INJECTION WAS THE CAUSE. ABOUT 3 MONTHS AFTER THE RADIESSE INJECTION, THE PATIENT DEVELOPED TORTUOUS BLOOD VESSELS/VARICOSITIES. THE OUTCOME OF THE EVENTS WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 13-FEB-2023: THIS CASE WAS UPGRADED TO SERIOUS. THE EVENT TERM SOFT LUMP IN NECK WAS AMENDED TO SOFT LUMP IN NECK/ HYPODENSE RIGHT THYROID NODULE, CODING REMAINS UNCHANGED. EXPECTEDNESS FOR THE EVENT TORTUOUS BLOOD VESSELS/VARICOSITIES WAS REASSESSED. THE PATIENTS INITIALS, DATE OF BIRTH, AGE AND WEIGHT (58.9 KG) WERE PROVIDED. THE PATIENT WAS 51 YEARS OLD AT THE TIME OF THE EVENTS. THE PATIENT WAS INJECTED WI

  Patient problems: Vasodilatation

  MAUDE report 16429327 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR IS RELATED TO MDR 3013840437-2022-00171 REFERRING TO THE SAME PATIENT. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US HEALTH CARE PROFESSIONAL AND CONCERNS A FEMALE PATIENT. SHE WAS INJECTED SUBDERMALLY, WITH A TOTAL OF 1.5 ML OF RADIESSE, TO VOLUMIZE UNDER THE SCAR WHERE THERE WAS A SHELF-LIKE DEFORMITY, ON THE ABDOMEN (OFF LABEL USE OF DEVICE) AND FOR COLLAGEN STIMULATION, IN 2022. BATCH NUMBER WAS REPORTED AS A00020850. A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE WAS CONFIRMED AS A00020850 (EXPIRY DATE: 05/2024). ONE SYRINGE OF RADIESSE WAS DILUTED AND BLENDED WITH 0.5 ML OF BACTERIOSTATIC NORMAL SALINE (BNS) AND 0.25 ML 1% PLAIN LIDOCAINE (PRODUCT PREPARATION ISSUE). THE DILUTION RATIO WAS 2:1 RADIESSE TO DILUTANT AND IT WAS A MORE CONSERVATIVE APPROACH TO THIN IT OUT. THE PATIENT WAS INJECTED WITH A RETROGRADE TECHNIQUE AND THE REPORTER USED THE LARGEST AND LONGEST CANNULA (22G, 70MM) AND MADE 5 INSERTION POINTS USING A 23G NEEDLE AFTER NUMBING THE INJECTION SITES WITH 2% LIDOCAINE WITH EPINEPHRINE (REPORTED AS LIDO W/EPI), FOR COMFORT AND VASOCONSTRICTION. THE REPORTER WAS CONSERVATIVE

  Patient problems: Necrosis

  MAUDE report 16162289 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR IS RELATED TO MDR 3013840437-2022-00172 REFERRING TO THE SAME PATIENT. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US HEALTH CARE PROFESSIONAL AND CONCERNS A FEMALE PATIENT. SHE WAS INJECTED SUBDERMALLY, WITH A TOTAL OF 1.5 ML OF RADIESSE, TO VOLUMIZE UNDER THE SCAR WHERE THERE WAS A SHELF-LIKE DEFORMITY, ON THE ABDOMEN (OFF LABEL USE OF DEVICE) AND FOR COLLAGEN STIMULATION, IN 2022. BATCH NUMBER WAS REPORTED AS A00020850. A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE WAS CONFIRMED AS A00020850 (EXPIRY DATE: 05/2024). ONE SYRINGE OF RADIESSE WAS DILUTED AND BLENDED WITH 0.5 ML OF BACTERIOSTATIC NORMAL SALINE (BNS) AND 0.25 ML 1% PLAIN LIDOCAINE (PRODUCT PREPARATION ISSUE). THE DILUTION RATIO WAS 2:1 RADIESSE TO DILUTANT AND IT WAS A MORE CONSERVATIVE APPROACH TO THIN IT OUT. THE PATIENT WAS INJECTED WITH A RETROGRADE TECHNIQUE AND THE REPORTER USED THE LARGEST AND LONGEST CANNULA (22G, 70MM) AND MADE 5 INSERTION POINTS USING A 23G NEEDLE AFTER NUMBING THE INJECTION SITES WITH 2% LIDOCAINE WITH EPINEPHRINE (REPORTED AS LIDO W/EPI), FOR COMFORT AND VASOCONSTRICTION. THE REPORTER WAS CONSERVATIVE

  Patient problems: Obstruction/Occlusion

  MAUDE report 16161286 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US HEALTHCARE PROFESSIONAL AND CONCERNS A PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE, INTO THE JAWLINE (OFF LABEL USE OF DEVICE). DURING THE RADIESSE INJECTION, THE PATIENT EXPERIENCED A VASCULAR OCCLUSION. THE OUTCOME OF THE EVENT WAS UNKNOWN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15870654 ↗
• InjuryJun 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM AN US HEALTH CARE PROFESSIONAL AND CONCERNS A PATIENT. THE PATIENT WAS INJECTED WITH RADIESSE, INTO THE CHIN (OFF LABEL USE OF DEVICE). AFTER THE RADIESSE INJECTION, THE PATIENT EXPERIENCED THAT IT LOOKED LIKE THERE WAS AN OCCLUSION. THE REPORTER WANTED INFORMATION ON HOW TO BREAK DOWN RADIESSE. AS REPORTED, THE PATIENT WAS COMING IN FOR FOLLOW UP ON FRIDAY. THE OUTCOME OF THE EVENT WAS UNKNOWN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14799901 ↗
• InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR IS RELATED TO MDR 3013840437-2021-00200 REFERRING TO THE SAME PATIENT. THIS CASE WAS LINKED TO LSSMV CASE NUMBER (B)(6) REFERRING TO THE SAME PATIENT. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US PHYSICIAN AND CONCERNS A MALE PATIENT (HIMSELF). HE WAS INJECTED WITH RADIESSE®. AFTER THE TREATMENT WITH RADIESSE®, THE PATIENT EXPERIENCED A NODULE IN HIS NECK. THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 21-SEP-2021: THIS CASE WAS UPGRADED TO SERIOUS. THE EVENTS OFF LABEL USE OF DEVICE, SLIGHT DISCOLORATION, SIGNIFICANT BRUISING/SMALL HEMATOMA AND SIGNIFICANT DEPENDENT EDEMA/ SWELLING WERE ADDED. THE EVENT TERM NODULE WAS AMENDED TO TWO DISCRETE NODULES/ GENERALIZED EXCESS TISSUE GROWTH, AND THE CODING REMAINED UNCHANGED. THE PATIENTS AGE, YEAR OF BIRTH AND WEIGHT ((B)(4)) WERE PROVIDED. HE WAS 57 YEARS OLD AT THE TIME OF THE EVENT (AMBIGUOUSLY REPORTED AS (B)(6)). IT WAS CONFIRMED THAT HE WAS INJECTED WITH A TOTAL OF 3 ML OF RADIESSE, INTO THE NECK (OFF LABEL USE OF DEVICE), ON 26-APR-2021. THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE WAS CONFIRMED AS 100134805 (EXPIRY DATE 11/2023). A LOT SEARCH IN THE GLOBAL SAFETY DA

  Patient problems: Skin Discoloration

  MAUDE report 12579418 ↗
• InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR IS RELATED TO MDR 3013840437-2021-00201 REFERRING TO THE SAME PATIENT. THIS CASE WAS LINKED TO LSSMV CASE NUMBER (B)(4), REFERRING TO THE SAME PATIENT. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US PHYSICIAN AND CONCERNS A MALE PATIENT (HIMSELF). HE WAS INJECTED WITH RADIESSE®. AFTER THE TREATMENT WITH RADIESSE®, THE PATIENT EXPERIENCED A NODULE IN HIS NECK. THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 21-SEP-2021: THIS CASE WAS UPGRADED TO SERIOUS. THE EVENTS OFF LABEL USE OF DEVICE, SLIGHT DISCOLORATION, SIGNIFICANT BRUISING/SMALL HEMATOMA AND SIGNIFICANT DEPENDENT EDEMA/ SWELLING WERE ADDED. THE EVENT TERM NODULE WAS AMENDED TO TWO DISCRETE NODULES/ GENERALIZED EXCESS TISSUE GROWTH, AND THE CODING REMAINED UNCHANGED. THE PATIENTS AGE, YEAR OF BIRTH AND WEIGHT ((B)(6)) WERE PROVIDED. HE WAS (B)(6) AT THE TIME OF THE EVENT (AMBIGUOUSLY REPORTED AS (B)(6)). IT WAS CONFIRMED THAT HE WAS INJECTED WITH A TOTAL OF 3 ML OF RADIESSE, INTO THE NECK (OFF LABEL USE OF DEVICE), ON (B)(6) 2021. THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE WAS CONFIRMED AS 100134805 (EXPIRY DATE 11/2023). A LOT SEARCH IN THE GLOBAL SAFETY DATABAS

  Patient problems: Nodule

  MAUDE report 12579209 ↗
• InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US PHYSICIAN AND CONCERNS A FEMALE PATIENT. SHE WAS INJECTED WITH RADIESSE®. THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE® WAS CONFIRMED AS 100132266 (EXPIRY DATE 07/2023). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. AFTER THE TREATMENT WITH RADIESSE®, THE PATIENT EXPERIENCED A VASCULAR EXCLUSION ON THE LEFT SIDE OF HER FACE. IT WAS URGENT. THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 10-FEB-2021: THE PATIENTS AGE WAS CONFIRMED. SHE WAS (B)(6) YEARS-OLD AT THE TIME OF THE EVENT. THE PATIENT WAS INJECTED WITH A TOTAL OF 1.3 ML OF RADIESSE®, INTO BILATERAL NASOLABIAL FOLDS (REPORTED AS NLF), ON (B)(6) 2021. THE PATIENT HAD LAST RADIESSE® INJECTED, ON (B)(6) 2020. CONCOMITANT MEDICATION WAS REPORTED AS NONE. ON (B)(6) 2021, TWO DAYS AFTER THE TREATMENT WITH RADIESSE®, THE PATIENT EXPERIENCED A VASCULAR OCCLUSION. AS A CORRECTIVE TREATMENT, THE PATIENT RECEIVED BACRIM DS, TOPICAL ANTIBIOTIC OINTMENT AND DRESSINGS. NO RELEVANT LABORATORY TESTS WERE PERFORMED. THE OUTCOME OF THE EVENT WAS REPORTED AS PENDING. DUE TO THE PROVIDED INFORMATION THE OUTCOME OF THE EVENT REMAINED UN

  Patient problems: Obstruction/Occlusion

  MAUDE report 11335244 ↗
• InjuryNov 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US NURSE PRACTITIONER (NP) AND CONCERNS A (B)(6) FEMALE PATIENT. THE PATIENT WAS INJECTED WITH 1.5CC OF RADIESSE TO THE CHIN, RIGHT ORAL COMMISSURE AND RIGHT MARIONETTE LINES ON (B)(6) 2019. LOT 100123412 (EXPIRY 09/26/2022). MEDICAL HISTORY POSITIVE FOR FILLER INJECTIONS 15 YEARS AGO. FURTHER MEDICAL HISTORY REPORTED AS NONE. THE PATIENT WAS INJECTED TO THE CHIN WITHOUT PROBLEMS. THE NP THEN USED THE FANNING TECHNIQUE TO INJECT THE ORAL COMMISSURE. THE PATIENT PUT HER TONGUE BEHIND HER LIP AND PUSHED HER LIP DOWN. WHEN SHE DID SO, THERE WAS IMMEDIATE BLANCHING AND THE AREA TURNED PURPLE. THE NP STARTED MASSAGING THE AREA. WITHIN ONE MINUTE, THE AREA BECAME PURPLE. THE NP ASKED THE PHYSICIAN TO COME IN AND ASSIST WITH THE PATIENT. CORRECTIVE TREATMENT REPORTED AS CONTINUED MASSAGE, WARM COMPRESSES, AND INJECTION OF HYLENEX (HYALURONIDASE) WITHOUT RESOLUTION. THE AREA WAS PURPLE AND MOTTLED. FURTHER CORRECTIVE TREATMENT WITH NITROPASTE, ASPIRIN, AND INJECTION OF SODIUM THIOSULFATE (STS) WAS DONE. THE PATIENT STAYED IN THE OFFICE FOR HOURS AND LEFT THAT NIGHT WITH THE INJECTED AREA STILL VERY DUSKY BUT A LITTLE BETTER. ON (B)(6) 2019, THE P

  Patient problems: Necrosis

  MAUDE report 9350592 ↗
• InjuryOct 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MERZ SALES REPRESENTATIVE CONCERNING A (B)(6) FEMALE PATIENT WHO RECEIVED RADIESSE. RELEVANT MEDICAL HISTORY INCLUDED WELL CONTROLLED HYPOTHYROIDISM AND PERIODIC RADIESSE INJECTIONS SINCE 2014 WITHOUT ANY ADVERSE EFFECT. CONCOMITANT MEDICATIONS INCLUDED SYNTHROID 75 MCG. IN 2019 THE HCP INJECTED THE PATIENT WITH 1.5 ML OF RADIESSE INTO THE FACE TO ACHIEVE SYMMETRY OF HER FACE. IT WAS NOTED THAT MOST OF THE RADIESSE WAS INJECTED INTO THE LOWER PART OF THE MIDDLE THIRD AND INTO THE UPPER PART OF THE LOWER THIRD OF HER FACE WITH MORE OF THE RADIESSE INJECTED IN THE LEFT SIDE OF THE FACE (THAN IN THE RIGHT SIDE) SINCE THE LEFT SIDE PRESENTED A GREATER DEGREE OF SAGGING. NO BLOCKAGE WAS PERFORMED WITH ANESTHESIA INSTEAD ICE WAS APPLIED BEFORE PERFORMING THE DIFFERENT PUNCTURES. ON (B)(6) 2019 THE PATIENT STATED THAT THE LEFT SIDE OF HER FACE FELT HOT AND SHE EXPERIENCED PRESSURE. THE PATIENT RETURNED TO THE CLINIC ON (B)(6) 2019 AT WHICH TIME THERE WAS BRUISING ON THE LEFT SIDE OF HER FACE. THE HCP EXAMINED THAT PATIENT AND DIAGNOSED THE PATIENT WITH CELLULITIS IN THE LEFT HEMICARA THAT EXTENDED FROM THE LOWER T

  Patient problems: Cellulitis

  MAUDE report 9252755 ↗
• InjurySep 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A MEDICAL SPA EMPLOYEE VIA A MERZ SALE REPRESENTATIVE CONCERNING A (B)(6) FEMALE PATIENT WHO RECEIVED RADIESSE. RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2019, THE PATIENT WAS INJECTED WITH ONE (1) SYRINGE OF RADIESSE TO AN UNSPECIFIED LOCATION. ON AN UNSPECIFIED DATE POST INJECTION, THE PATIENT EXPERIENCED A HYPERSENSITIVITY REACTION TO RADIESSE WITH LOWER FACE SWELLING. IT WAS REPORTED THAT THE PATIENT WAS SEEN ON (B)(6) 2019 AND THE LOWER FACE SWELLING WAS OBSERVED. TREATMENT AND OUTCOME WERE NOT REPORTED. THE LOT NUMBER WAS REPORTED AS 100117959 WITH AN EXPIRY DATE OF 27 FEBRUARY 2022. FOLLOW UP INFORMATION WAS RECEIVED ON 23 SEPTEMBER 2019 FROM THE REPORTER. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED PRIOR FILLERS, NOT FURTHER SPECIFIED. THERE WERE NO RELEVANT CONCOMITANT MEDICATIONS. THE INJECTOR WAS A PHYSICIAN. ON (B)(6) 2019 THE PATIENT EXPERIENCED THE INJECTION AREA WAS RED, SWOLLEN, WARM AND NOT TOO HARD TO TOUCH. NO LABORATORY TESTING WAS DONE. TREATMENT INCLUDED STEROID DOSEPAK AND KEFLEX 500MG TWICE DAILY (BID) FOR EIGHT (8) DAYS STARTING (B)(6) 2019. AN ADDITIONAL MEDROL DOSEPAK WA

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 9131668 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P050037, P050052. One submission often covers many models, so check the product and lot details in each record.

• Z-2607-2016 · May 20, 2016 · Terminated
  Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for sub-dermal implantation for the correction of m
• Z-0145-2012 · Aug 18, 2011 · Terminated
  MERZ AESTHETICS, Radiesse Volume Advantage 1.5 CC, Injectable Implant, Part Number 8071M0H1 and 8071M0K1, Sterile, Rx ONLY. Part Number 8071M4K1 distributed in Canada Part Number
• Z-2221-2011 · Apr 6, 2011 · Terminated
  Radiesse, Injectable Implant - 1.3cc Syringe, Sterile, Sterilized Using Steam, Use Before 2013-01, Ref 8046M7, Lot 1024417, Manufactured by: BioForm Medical Inc, 4133 Courtney Rd #