Radiesse Volume Advantage 1.5cc 8071M0K1Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI M2138071M0K15), received between May 20, 2016 and Dec 11, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 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(+) INTO THE NASOLABIAL FOLD. RADIESSE(+) WAS DILUTED (PRODUCT PREPARATION ISSUE, OFF LABEL USE OF DEVICE) IN A 2:1 RATIO. THE PATIENT WAS PREVIOUSLY INJECTED WITH HYALURONIC ACID (REPORTED AS HA) AROUND THE SAME AREA. AFTER THE RADIESSE(+) INJECTION, THE PATIENT EXPERIENCED AN ADVERSE EVENT WHICH LOOKED LIKE SWELLING, REDNESS AND BRUISING IN THE NASOLABIAL FOLD AREA AS WELL AS AROUND THE LIP AREA. THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW UP INFORMATION WAS RECEIVED ON 04-DEC-2025: THE CASE WAS UPGRADED TO SERIOUS. THE SUSPECT PRODUCT WAS RECODED FROM RADIESSE(+) TO RADIESSE. THE EVENT BRUISING WAS DELETED. THE EVENTS VASCULAR OCCLUSION AND PIMPLES WERE ADDED. THE PATIENTS INITIALS, DATE OF BIRTH, AGE, GENDER (FEMALE) AND WEIGHT (AMBIGUOUSLY REPORTED AS 125) WERE PROVIDED. SHE WAS 45 YEARS OLD AT THE TIME OF THE EVENT. THE PATIENT WAS INJECTED SUBDERMALLY WITH 0.5 ML OF RADIESSE INTO THE NASOLABIAL FOLD, MARIONETTE LINES, CHIN CREASE, PRE-JOWL SULCUS AND JAWLINE (OFF LABEL USE OF DEVICE), ON (B)(6) 2025. BATCH NUMBER WAS REPORTE

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

  MAUDE report 23778626 ↗
• InjuryApr 3, 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 HANDS. THE PATIENT WENT BACK TO WORK AS A HOUSE CLEANER THE DAY AFTER THE TREATMENT WITH RADIESSE. AFTER THE RADIESSE INJECTION, THE PATIENT EXPERIENCED LATE ONSET OF SWELLING AND A FEELING OF PAIN. THE OUTCOME OF THE EVENTS WAS UNKNOWN. FOLLOW-UP INFORMATION WAS RECEIVED ON 21-MAR-2023: THIS CASE WAS UPGRADED TO SERIOUS. THE EVENT TERM LATE ONSET OF SWELLING WAS CHANGED TO DELAY HYPERSENSITIVITY AND THE CODING WAS CHANGED FROM INJECTION SITE SWELLING TO INJECTION SITE HYPERSENSITIVITY. THE PATIENTS AGE, DATE OF BIRTH AND WEIGHT (81.64 KG) WERE PROVIDED. SHE WAS 56 YEARS OLD AT THE TIME OF THE EVENTS. SHE WAS INJECTED, WITH A TOTAL OF 3 ML OF RADIESSE, INTO THE HANDS, ON 21-FEB-2023. BATCH NUMBER WAS REPORTED AS A00043120 (EXPIRY DATE: 01/2025). 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 A00043120 (EXPIRY DATE: 01/2025). RADIESSE 1.5 ML WAS MIXED WITH 0.2 ML OF 1% LIDOCAINE ON EACH HAND. SHE HAD NO PREVIOUS FILLER TREATMENTS. THE PATIENTS MEDICAL HIST

  Patient problems: Local Reaction

  MAUDE report 16664457 ↗
• InjuryAug 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE WAS LINKED TO (B)(4), REFERRING TO THE SAME REPORTER. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US HEALTHCARE PROFESSIONAL AND CONCERNS A (B)(6)-YEAR-OLD FEMALE PATIENT. SHE WAS INJECTED WITH RADIESSE®, INTO THE BILATERAL CHEEK, MALAR AND ALA REGIONS, ON (B)(6) 2019. A SYRINGE WAS SPLIT BETWEEN BOTH CHEEKS. THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE® WAS CONFIRMED AS 100123768 (EXPIRY DATE 10/2022). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. TOPICAL LIDOCAINE 15%/BETACAINE 5% WAS APPLIED PRE-INJECTION, AND THE AREA WAS CLEANSED WITH VIONEX AS A PREP PRE INJECTION. THE INJECTION WAS WELL TOLERATED. THE PATIENT HAD A HISTORY OF SIMILAR RADIESSE® INJECTION PLANS SINCE 2016 (AS REPORTED). THE PATIENT WAS A MEDICAL DOCTOR. AFTER THE RADIESSE® INJECTION, THE PATIENT WAS EXPERIENCING NUMBNESS AND TINGLING, INTERMITTENTLY OVER 2 WEEKS. AN INTERVENTION WAS OFFERED, BUT THE PATIENT DID NOT WISH TO RETURN FOR A VISIT. SHE DECLINED AND PREFERRED TO USE WARM COMPRESS/MASSAGE AND OVER-THE-COUNTER PAIN RELIEVERS AS NEEDED. ON (B)(6) 2020 (AMBIGUOUSLY REPORTED AS (B)(6) 2019), THE PATIENT WAS OFFERED A MEDRYL DOSE PACK AND SHE DECLINED THE INTER

  Patient problems: Cancer

  MAUDE report 12304329 ↗
• InjuryMar 24, 2020Adverse 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 FEMALE PATIENT. SHE WAS INJECTED WITH RADIESSE® INTO THE HANDS, ON (B)(6) 2019. IN (B)(6) 2019, SINCE THE TREATMENT WITH RADIESSE®, THE PATIENT'S LEFT HAND WAS SWOLLEN AND HAD VERY UNNATURAL APPEARANCE. THE PATIENT THOUGHT THAT TOO MUCH PRODUCT WAS INJECTED. THE OUTCOME OF THE EVENT WAS NOT REPORTED. FOLLOW-UP INFORMATION WAS RECEIVED ON 25-FEB-2020: THIS CASE WAS UPGRADED TO SERIOUS. THE EVENTS PAIN WITH TOUCH AND MILD ERYTHEMA WERE ADDED. THE PATIENTS INITIALS AND DATE OF BIRTH WERE PROVIDED. SHE WAS (B)(6) YEARS OLD. SHE WAS INJECTED WITH A TOTAL OF 2 ML OF RADIESSE® (1 ML PER HAND). BATCH NUMBER WAS REPORTED AS 100123538 (EXPIRY DATE: 09/2022). THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR RADIESSE® WAS CONFIRMED AS 100123538 (EXP. 09/2022). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. THE PATIENTS MEDICAL HISTORY INCLUDED BREAST CANCER AND THYROID CANCER. THE PATIENTS PAST MEDICAL HISTORY INCLUDED A MASTECTOMY AND A LYMPHADENECTOMY TO THE LEFT SIDE. CONCOMITANT MEDICATIONS WERE REPORTED AS NONE. ON (B)(6) 2019, ONE DAY AFTER THE RADIESSE® INJECTION, THE PATIENT EXPE

  Patient problems: Swelling

  MAUDE report 9875545 ↗
• InjuryFeb 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOW UP INFORMATION WAS RECEIVED FROM THE PHYSICIAN ON 13-FEB-2019: THE PATIENT'S INITIALS, AGE, AND DATE OF BIRTH WERE REPORTED. CONCOMITANT MEDICATIONS REPORTED AS ZOLOFT (SERTRALINE) 60MG SIX DAYS PER WEEK, XANAX (ALPRAZOLAM) 0.5MG 1-2 NIGHTS PER WEEK, AND PERLANE INJECTED TO DIFFERENT AREAS "EXCEPT THE LATERAL ORAL COMMISSURES" ON (B)(6) 2010. ONSET DATE REPORTED AS 1-2 MONTHS POST RADIESSE INJECTIONS. THE PATIENT PRESENTED FOR RECHECK ON (B)(6) 2010 BECAUSE OF THE LUMPS. TREATMENT REPORTED AS ABOVE. THE KENALOG + 5FU INJECTIONS WERE DOSED AT ABOUT 20MG-25MG PER CC. THE NODULES WOULD SHRINK TO "ALMOST GONE" POST TREATMENT BUT RECURRED OVER THE NEXT SEVERAL MONTHS. CAUSALITY REPORTED AS RELATED.

  Patient problems: No Code Available

  MAUDE report 8312057 ↗
• InjuryMar 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A (B)(6)-YEAR-OLD FEMALE PATIENT, A NURSE PRACTITIONER, WHO WAS INJECTED WITH 1CC OF RADIESSE ABOUT ONE MONTH AGO FOR HANDS INDICATION. CONCOMITANT MEDICATION REPORTED AS SYNTHROID (LEVOTHYROXINE). MEDICAL HISTORY POSITIVE FOR SULFA ALLERGY. RIGHT AFTER INJECTION (ALSO REPORTED AS (B)(6) 2018), THE PATIENT EXPERIENCED SWELLING, PINKNESS AND PAIN TO THE RIGHT HAND. IT WAS SO PAINFUL, SHE COULD NOT SLEEP THAT NIGHT. THE FOLLOWING DAY, SHE DEVELOPED THE SAME SYMPTOMS IN HER LEFT HAND. AN ORTHOPEDIC SURGEON FRIEND THOUGHT SHE HAD CELLULITIS AND STARTED HER ON AN UNSPECIFIED BROAD SPECTRUM ANTIBIOTIC. SHE DID NOT OTHERWISE SEE A PHYSICIAN. REPORTER CLARIFIED THE ANTIBIOTIC WAS NOT STARTED AS A PROPHYLACTIC MEASURE BUT AS TREATMENT. THE PATIENT EXPERIENCED IMPROVEMENT IN HER SYMPTOMS "RIGHT AFTER" STARTING ANTIBIOTIC. THE SYMPTOMS WERE RESOLVED AFTER THREE WEEKS. LOT NUMBER REPORTED AS 100089473.

  Patient problems: Cellulitis

  MAUDE report 7327336 ↗
• InjuryNov 28, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT A (B)(6) FEMALE PATIENT WAS INJECTED WITH RADIESSE. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS NOT REPORTED. ON (B)(6) 2016, THE PATIENT WAS INJECTED WITH 0.4 CC OF RADIESSE TO THE GLABELLA. ON (B)(6) 2016, THE PATIENT REPORTED ERYTHEMA, TENDERNESS, AND "BLACK AREA ON THE SKIN" NEAR THE BRIDGE OF THE NOSE. ON 22-NOV-2016, FOLLOW UP INFORMATION WAS RECEIVED FROM THE PHYSICIAN. PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS CLARIFIED AS NONE. ON (B)(6) 2016, THE PATIENT PRESENTED FOR A FOLLOW UP APPOINTMENT WITH THE PHYSICIAN AND WAS DIAGNOSED WITH A VASCULAR OCCLUSION. TREATMENT REPORTED AS 0.4 ML OF HYALURONIDASE, NITROPASTE, KEFLEX, VALTREX, ASPIRIN, AND A MEDROL DOSE PACK. PATIENT WAS INSTRUCTED TO PERFORM MASSAGE AND APPLY WARM COMPRESSES EVERY HOUR. SHE WAS REFERRED TO A PLASTIC SURGEON, WHO NOTED THE PATIENT'S SKIN WAS "ISCHEMIC ALREADY, THE SKIN WAS GOING TO DIE" AND ADVISED "NORMAL WOUND CARE." CAUSALITY REPORTED AS RELATED. OUTCOME REPORTED AS ONGOING.

  Patient problems: Occlusion

  MAUDE report 6129033 ↗
• InjuryMay 20, 2016Insufficient Device Problem Information

  ON (B)(6) 2016, A (B)(6) FEMALE PATIENT WAS INJECTED WITH 1.5CC OF RADIESSE TO THE CHEEKS. ON AN UNSPECIFIED DATE POST INJECTION, PATIENT EXPERIENCED SWELLING TO THE UPPER FACE, AND HER EYES WERE SWOLLEN SHUT. SHE WENT TO EITHER HER PRIMARY CARE PHYSICIAN OR THE EMERGENCY ROOM AND WAS GIVEN A STEROID SHOT. ON (B)(6) 2016, PATIENT RETURNED TO INJECTOR'S OFFICE AND THE SWELLING WAS 80% RESOLVED, BUT HER SKIN WAS STILL VERY TIGHT. SHE WAS GIVEN AQUAPHOR TO APPLY TOPICALLY. PATIENT WAS CONTACTED BY THE INJECTOR'S OFFICE TODAY, (B)(6) 2016, AND REPORTED THE SWELLING IS COMPLETELY RESOLVED.

  Patient problems: Reaction; Swelling

  MAUDE report 5670108 ↗

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 #