BioZorb F0202Recalls & reported problems

Summary

The FDA's MAUDE database contains 192 adverse event reports that list this exact device (DI 15420045513983), received between Sep 5, 2023 and Sep 30, 2026 — classified as 189 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (13 reports).

2 FDA recall records name this device's identifier, 2 still open.

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 16, 2026.

Recalls naming this device

1. Oct 10, 2024Open, Classified

   Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.

   Z-0328-2025 · Root cause: Device Design · Recall details · FDA record ↗

2. Mar 13, 2024Open, Classified

   Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device

   Z-1733-2024 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 192 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Breast Discomfort/Pain; Breast Mass

  MAUDE report 50949203 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  Hologic has received correspondence arising from litigation. The litigation alleges that a patient of undisclosed age, on (b)(6) 2018, underwent a right breast lumpectomy with BioZorb placement and a simultaneous left breast lift. Shortly thereafter, the patient was diagnosed with ductal carcinoma in her right breast, and on (b)(6) 2018, she underwent re-excision with BioZorb replacement. Following the surgeries, the patient developed a painful, long-term seroma in her right breast, along with persistent pain and tenderness at the implant site, nodule formation, and lymph node swelling that continued for years. Patient required needle drainage and was told she was experiencing "delayed healing." Patient was later informed that Hologic had extended the expected resorption timeline for BioZorb - potentially up to two years, well beyond what she had originally been told. Patient has since suffered years of chronic pain, lymph node swelling, and an inability to wear a bra or swimsuit for any meaningful length of time without significant discomfort, requiring ongoing licensed massage therapy and lymph drainage at her own expense. In (b)(6) 2026, the Patient observed new, deeper dimpling

  Patient problems: Breast Discomfort/Pain; Breast Mass; Deformity/ Disfigurement; Impaired Healing; Nodule; Seroma; Swelling/ Edema; Swollen Lymph Nodes/Glands

  MAUDE report 50161479 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Hologic has received correspondence arising from litigation. The litigation alleges that a 55 year old patient was implanted on (b)(6) 2020 with a BioZorb marker following a surgical procedure for a Left breast lumpectomy. The patient underwent the prescribed Radiation and Endocrine therapy. On (b)(6) 2023 the patient presented at a medical consultation with a painful persistent palpable mass in the left breast. The pain increased with movement and when pressed along the implant site incision line. The patient indicated the symptoms were persistent during the last 3 years. The MD discussed with the patient the possibility to schedule an explanation surgery and the patient agreed. On (b)(6) 2023 the patient underwent a surgical procedure for left breast mass excision, together with the BioZorb implant which was included in the breast mass. No other relevant Information was provided.

  Patient problems: Breast Discomfort/Pain; Breast Mass; Limb Pain

  MAUDE report 50037276 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  HOLOGIC HAS RECEIVED CORRESPONDENCE ARISING FROM LITIGATION. THE LITIGATION ALLEGES THAT A 67-YEAR-OLD PATIENT WAS IMPLANTED ON (B)(6) 2023 WITH A BIOZORB MARKER FOLLOWING A SURGICAL PROCEDURE FOR A LEFT BREAST LUMPECTOMY. ON (B)(6) 2024 PATIENT PRESENTED WITH CONTINUED PAIN AT THE SITE OF THE IMPLANT AND SHE DESIRES THE REMOVAL OF THE BIOZORB DEVICE. ON THE SAME DAY THE PATIENT UNDERWENT A SURGICAL PROCEDURE FOR BIOZORB REMOVAL. NO OTHER RELEVANT INFORMATION WAS PROVIDED. THIS REPORT IS BEING SUBMITTED PURSUANT TO 21 CFR PART 803 BASED ON INFORMATION MADE AVAILABLE TO HOLOGIC THROUGH LITIGATION. CONSISTENT WITH 21 CFR 803.16, THE SUBMISSION OF THIS REPORT IS NOT INTENDED, AND SHALL NOT BE CONSTRUED, AS AN ADMISSION, ACKNOWLEDGMENT, OR CONFIRMATION BY HOLOGIC THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 25219655 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  HOLOGIC HAS RECEIVED CORRESPONDENCE ARISING FROM LITIGATION. THE LITIGATION ALLEGES THAT A PATIENT UNDERWENT A RIGHT BREAST LUMPECTOMY WITH BIOZORB PLACEMENT ON (B)(6) 2023. IT IS FURTHER ALLEGED THAT IN THE MONTHS FOLLOWING THE LUMPECTOMY, THE PATIENT DEVELOPED INTERMITTENT RIGHT BREAST AND AXILLARY DISCOMFORT. IT WAS REPORTED IN THE LITIGATION THAT "IMAGING IN (B)(6) 2024 SHOWED ONLY SCAR TISSUE AND A SEROMA WITHOUT EVIDENCE OF RECURRENT DISEASE. HOWEVER, BY (B)(6) 2024, EXAMINATION REVEALED A FIRM AREA WITH ASSOCIATED DIMPLING IN THE REGION OF THE BIOZORB." ACCORDING TO THE LITIGATION, THE PATIENT REPORTED A "FIRM, PAINFUL MASS AT THE LUMPECTOMY SITE AND ONGOING TENDERNESS" TO HER CARE TEAM. IT IS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT RIGHT BREAST LUMPECTOMY WITH REMOVAL OF THE BIOZORB. THIS REPORT IS BEING SUBMITTED PURSUANT TO 21 CFR PART 803 BASED ON INFORMATION MADE AVAILABLE TO HOLOGIC THROUGH LITIGATION. CONSISTENT WITH 21 CFR 803.16, THE SUBMISSION OF THIS REPORT IS NOT INTENDED, AND SHALL NOT BE CONSTRUED, AS AN ADMISSION, ACKNOWLEDGMENT, OR CONFIRMATION BY HOLOGIC THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

  Patient problems: Breast Discomfort/Pain; Breast Mass; Scar Tissue; Seroma

  MAUDE report 24608095 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  HOLOGIC HAS RECEIVED CORRESPONDENCE ARISING FROM LITIGATION. THE LITIGATION ALLEGES THAT A PATIENT UNDERWENT A LEFT BREAST LUMPECTOMY WITH BIOZORB PLACEMENT ON (B)(6) 2019. IT IS ALLEGED THAT THE PATIENT "EXPERIENCED POSTOPERATIVE WOUND-HEALING COMPLICATIONS, INCLUDING A SKIN REACTION TO METHYLENE BLUE WITH A FOCAL AREA OF SKIN NECROSIS, WHICH REQUIRED OFFICE DEBRIDEMENT. DUE TO THESE WOUND ISSUES, HER PLANNED RADIATION THERAPY WAS DELAYED." IT IS FURTHER ALLEGED THAT ON (B)(6) 2019, THE PATIENT WAS "FOUND TO HAVE PARTIAL EXPOSURE OF A FOREIGN BODY AT THE SURGICAL SITE, IDENTIFIED AS THE PREVIOUSLY IMPLANTED BIOZORB MARKER." IT IS REPORTED THAT THE BIOZORB DEVICE WAS REMOVED ON (B)(6) 2019. THIS REPORT IS BEING SUBMITTED PURSUANT TO 21 CFR PART 803 BASED ON INFORMATION MADE AVAILABLE TO HOLOGIC THROUGH LITIGATION. CONSISTENT WITH 21 CFR 803.16, THE SUBMISSION OF THIS REPORT IS NOT INTENDED, AND SHALL NOT BE CONSTRUED, AS AN ADMISSION, ACKNOWLEDGMENT, OR CONFIRMATION BY HOLOGIC THAT THE DEVICE CAUSED.

  Patient problems: Erosion; Impaired Healing; Necrosis

  MAUDE report 24607089 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  HOLOGIC HAS RECEIVED CORRESPONDENCE ARISING FROM LITIGATION. THE LITIGATION ALLEGES THAT A PATIENT UNDERWENT A LEFT BREAST LUMPECTOMY WITH A BIOZORB IMPLANT ON (B)(6) 2023. IT IS ALLEGED THAT IN THE MONTHS FOLLOWING SURGERY, THE PATIENT EXPERIENCED PERSISTENT PAIN AND SWELLING AT THE LUMPECTOMY SITE. IT IS ALLEGED THAT ON (B)(6) 2024, THE AREA SHOWED ERYTHEMA AND WAS "MILDLY SWOLLEN." IN (B)(6) 2025, IT IS ALLEGED THAT THE PATIENT PRESENTED WITH "AN UNUSUAL NON-HEALING WOUND AND DRAINAGE AT THE PRIOR LUMPECTOMY SITE." IT IS ALLEGED THAT "THE DEVICE WAS NOTED TO HAVE ERODED THROUGH THE BREAST TISSUE." ON (B)(6) 2025, IT IS ALLEGED THAT THE PATIENT WAS ADMITTED FOR REMOVAL "OF A LEFT BREAST FOREIGN BODY AND PLACEMENT OF A WOUND VACUUM." IT IS REPORTED THAT "OPERATIVE FINDINGS CONFIRMED AN ERODING BIOZORB DEVICE AT THE LUMPECTOMY SITE, WITH EXCISION OF THE REMAINING BIOZORB MATERIAL AND THE SURROUNDING SCAR CAVITY." THIS REPORT IS BEING SUBMITTED PURSUANT TO 21 CFR PART 803 BASED ON INFORMATION MADE AVAILABLE TO HOLOGIC THROUGH LITIGATION. CONSISTENT WITH 21 CFR 803.16, THE SUBMISSION OF THIS REPORT IS NOT INTENDED, AND SHALL NOT BE CONSTRUED, AS AN ADMISSION, ACKNOWLEDGMENT, OR CONFI

  Patient problems: Abnormal scarring; Breast Discomfort/Pain; Erosion; Erythema; Swelling/ Edema

  MAUDE report 24606810 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  HOLOGIC HAS RECEIVED CORRESPONDENCE ARISING FROM LITIGATION. THE LITIGATION ALLEGES A PATIENT RECEIVED A BIOZORB BREAST MARKER ON (B)(6) 2016, WITH A MARGIN RE-EXCISION ON (B)(6), 2016. IT IS ALLEGED THAT IN LATE 2018, THE PATIENT DEVELOPED "RIGHT BREAST PAIN AND PALPABLE LUMPS IN THE UPPER OUTER QUADRANT," AND "IMAGING AT THAT TIME SHOWED POST-SURGICAL CHANGES AND WAS INTERPRETED AS BENIGN." IT IS FURTHER ALLEGED THAT IN (B)(6) 2023, THE PATIENT EXPERIENCED AN "INFLAMMATORY EVENT INVOLVING THE RIGHT BREAST," AND "PRESENTED WITH SIGNIFICANT PAIN, ERYTHEMA, EDEMA, AND FEVER UP TO 102 DEGREES, AND WAS ADMITTED FOR RIGHT BREAST CELLULITIS." ADDITIONALLY, IT IS REPORTED THAT "CT IMAGING DEMONSTRATED POSTSURGICAL CHANGES, SKIN THICKENING, AND A FLUID COLLECTION CONSISTENT WITH ABSCESS FORMATION." THE PATIENT IS REPORTED TO HAVE "REQUIRED HOSPITALIZATION, INTRAVENOUS ANTIBIOTICS, AND PROLONGED OUTPATIENT TREATMENT." FURTHER, THE LITIGATION ALLEGES THAT THE PATIENT'S "BREAST SYMPTOMS DID NOT FULLY RESOLVE, AND SHE CONTINUED TO REPORT RIGHT BREAST PAIN AND SCARRING ON SUBSEQUENT IMAGING STUDIES. BY EARLY 2025, SCREENING MAMMOGRAPHY AGAIN REQUIRED ADDITIONAL IMAGING DUE TO ABNORMALITIES AND

  Patient problems: Abnormal scarring; Abscess; Breast Discomfort/Pain; Cellulitis; Erythema; Fever; Inflammation; Swelling/ Edema

  MAUDE report 24605823 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  HOLOGIC HAS RECEIVED CORRESPONDENCE ARISING FROM LITIGATION. THE LITIGATION ALLEGES THAT A PATIENT RECEIVED A BIOZORB IMPLANT POST LUMPECTOMY ON (B)(6) 2022. IT IS ALLEGED THAT THE PATIENT DEVELOPED COMPLICATIONS AT THE LUMPECTOMY SITE, WHICH INCLUDE MASTITIS, ABSCESS, REDNESS, SWELLING, PAIN, CHILLS AND PURULENT DRAINAGE. ADDITIONALLY, IT IS REPORTED THAT THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2025, WITH A DIAGNOSIS OF MASTITIS AND ABSCESS AND UNDERWENT AN INCISION AND DRAINAGE PROCEDURE. IT IS REPORTED THAT "CLIPS FROM THE PRIOR BIOZORB WERE REMOVED DURING THE I&D PROCEDURE." THIS REPORT IS BEING SUBMITTED PURSUANT TO 21 CFR PART 803 BASED ON INFORMATION MADE AVAILABLE TO HOLOGIC THROUGH LITIGATION. CONSISTENT WITH 21 CFR 803.16, THE SUBMISSION OF THIS REPORT IS NOT INTENDED, AND SHALL NOT BE CONSTRUED, AS AN ADMISSION, ACKNOWLEDGMENT, OR CONFIRMATION BY HOLOGIC THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

  Patient problems: Abscess; Bacterial Infection; Breast Discomfort/Pain; Chills; Erythema; Purulent Discharge; Seroma; Swelling/ Edema

  MAUDE report 24604889 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  HOLOGIC HAS RECEIVED CORRESPONDENCE ARISING FROM LITIGATION. THE LITIGATION ALLEGES THAT A PATIENT RECEIVED A BIOZORB IMPLANT ON (B)(6) 2023, AFTER A PARTIAL MASTECTOMY. IT IS ALLEGED THAT IN EARLY 2024, THE PATIENT DEVELOPED SWELLING, HARDNESS, PAIN, REDNESS AND FLUID ACCUMULATION IN THE BREAST. IT IS FURTHER ALLEGED THAT THE PATIENT WAS TREATED WITH MASSAGE THERAPY, LYMPHEDEMA TREATMENT, COMPRESSION BRAS AND STEROIDS. ADDITIONALLY, IT IS ALLEGED THAT DUE TO THE BREAST SYMPTOMS, THE PATIENT EXPERIENCED INCREASING ANXIETY. IT IS REPORTED THAT THE PATIENT HAD THE BIOZORB SURGICALLY REMOVED ON (B)(6) 2025. THIS REPORT IS BEING SUBMITTED PURSUANT TO 21 CFR PART 803 BASED ON INFORMATION MADE AVAILABLE TO HOLOGIC THROUGH LITIGATION. CONSISTENT WITH 21 CFR 803.16, THE SUBMISSION OF THIS REPORT IS NOT INTENDED, AND SHALL NOT BE CONSTRUED, AS AN ADMISSION, ACKNOWLEDGMENT, OR CONFIRMATION BY HOLOGIC THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

  Patient problems: Anxiety; Breast Discomfort/Pain; Erythema; Seroma; Swelling/ Edema

  MAUDE report 24604783 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  HOLOGIC HAS RECEIVED CORRESPONDENCE ARISING FROM LITIGATION. THE LITIGATION ALLEGES THAT POST RIGHT BREAST LUMPECTOMY ON (B)(6) 2019, A PATIENT RECEIVED A BIOZORB DEVICE IMPLANT. IT IS ALLEGED THAT THE PATIENT HAS SUBSEQUENTLY EXPERIENCED PERSISTENT TENDERNESS AND DISCOMFORT AT THE LUMPECTOMY SITE AS WELL AS SEROMA, SCAR TISSUE AND PALPABLE MASS IN THE REGION OF THE BIOZORB. IT IS FURTHER ALLEGED THAT THE PATIENT EXPERIENCED WORSENING PAIN AND ERYTHEMA AND WAS TREATED WITH ANTIBIOTICS. IT IS ALLEGED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT SURGICAL EXCISION OF THE MASS, WHICH INCLUDED EXPLANTATION OF THE BIOZORB AND REMOVAL OF SURROUNDING NECROTIC TISSUE. THIS REPORT IS BEING SUBMITTED PURSUANT TO 21 CFR PART 803 BASED ON INFORMATION MADE AVAILABLE TO HOLOGIC THROUGH LITIGATION. CONSISTENT WITH 21 CFR 803.16, THE SUBMISSION OF THIS REPORT IS NOT INTENDED, AND SHALL NOT BE CONSTRUED, AS AN ADMISSION, ACKNOWLEDGMENT, OR CONFIRMATION BY HOLOGIC THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTABLE EV.

  Patient problems: Breast Discomfort/Pain; Breast Mass; Erythema; Inflammation; Necrosis; Scar Tissue; Seroma

  MAUDE report 24604641 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  HOLOGIC HAS RECEIVED CORRESPONDENCE ARISING FROM LITIGATION. THE LITIGATION ALLEGES THAT A PATIENT RECEIVED A BIOZORB IMPLANT POST LUMPECTOMY PROCEDURE ON (B)(6) 2021. IT IS ALLEGED THAT THE PATIENT HAS EXPERIENCED CHRONIC PAIN AND TENDERNESS AT THE LUMPECTOMY SITE IN ADDITION TO A PALPABLE MASS. IT IS ALLEGED THAT DUE TO ONGOING PAIN, TENDERNESS AND PALPABLE MASS, THE BIOZORB IMPLANT WAS REMOVED ON (B)(6) 2025. THIS REPORT IS BEING SUBMITTED PURSUANT TO 21 CFR PART 803 BASED ON INFORMATION MADE AVAILABLE TO HOLOGIC THROUGH LITIGATION. CONSISTENT WITH 21 CFR 803.16, THE SUBMISSION OF THIS REPORT IS NOT INTENDED, AND SHALL NOT BE CONSTRUED, AS AN ADMISSION, ACKNOWLEDGMENT, OR CONFIRMATION BY HOLOGIC THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

  Patient problems: Anxiety; Breast Discomfort/Pain; Breast Mass

  MAUDE report 24604434 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB DEVICE IMPLANT ON AN UNKNOWN DATE IN 2018. IT WAS FURTHER REPORTED THAT THE PATIENT HAS EXPERIENCED "SORENESS AND DISCOMFORT" AT AND AROUND THE SITE OF IMPLANTATION. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 24391384 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS DIAGNOSED WITH BREAST CANCER IN LATE 2023 AND RECEIVED A BIOZORB DEVICE IMPLANT ON AN UNKNOWN DATE. IT WAS FURTHER REPORTED THAT THE PATIENT HAS EXPERIENCED INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE "BURNING AND HOT SHOOTING PAIN." THE PATIENT REPORTS THAT PORTIONS OF THE DEVICE WERE REMOVED IN (B)(6) 2025 AND SINCE THAT TIME HAS EXPERIENCED "FLUID BUILDUP." IT IS REPORTED THAT ADDITIONAL IMAGING WILL BE REQUIRED TO DETERMINE IF AN ADDITIONAL PROCEDURE IS NEEDED TO ADDRESS THE REPORTED FLUID BUILDUP. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Seroma

  MAUDE report 24193061 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB DEVICE IMPLANT ON (B)(6) 2020. IT WAS FURTHER REPORTED THAT THE PATIENT HAS EXPERIENCED "CONTINUOUS PAIN IN THE BREAST, ARMPIT AND BACK." NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Back pain; Breast Discomfort/Pain

  MAUDE report 23719708 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 57-YEAR-OLD, WHITE PATIENT WEIGHING 68KG RECEIVED A BIOZORB IMPLANT ON AN UNKNOWN DATE, DURING A BREAST BIOPSY. IT WAS FURTHER REPORTED THAT THE PATIENT HAS EXPERIENCED INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE PAIN AND DEFORMITY. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement

  MAUDE report 23705576 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 73-YEAR-OLD, NON-HISPANIC WHITE FEMALE PATIENT WEIGHING 90 KG RECEIVED A BIOZORB DEVICE IMPLANT ON (B)(6) 2024. IT WAS FURTHER REPORTED THAT THE PATIENT HAS EXPERIENCED INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE PAIN, SWELLING, SLEEP DYSFUNCTION AND ERYTHEMA. PATIENT REPORTED MEDICATIONS: ALBUTEROL, AMLODIPINE BESYLATE, ASPIRIN, ATENOLOL, B-SUBLINGUAL, CALCIUM, VITAMIN D3, IRON, GLIPIZIDE, HYDRALAZINE, HYDROCHLOROTHIAZIDE, METFORMIN, STATIN, VITAMIN E. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Erythema; Sleep Dysfunction; Swelling/ Edema

  MAUDE report 22964795 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB DEVICE IMPLANT IN (B)(6) 2020. IT WAS FURTHER REPORTED THAT THE PATIENT HAS EXPERIENCED INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE CONSTANT PAIN, EXTREME SENSITIVITY, NUMBNESS AND FAILURE TO REABSORB. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Hypersensitivity/Allergic reaction; Numbness

  MAUDE report 22897264 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB DEVICE IMPLANT ON NOVEMBER (B)(6), 2023. IT WAS FURTHER REPORTED THAT THE PATIENT HAS EXPERIENCED INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE A HARD PALPABLE LUMP, CONSTANT PAIN AND DISCOMFORT, A BURNING FEELING, AND FAILURE TO REABSORB. ADDITIONALLY, IT IS REPORTED THAT THE PATIENT HAD ADDITIONAL SURGERY TO HAVE THE DEVICE REMOVED ON OR AROUND (B)(6) 2025. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Breast Mass; Burning Sensation

  MAUDE report 22896554 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 72-YEAR-OLD, NON-HISPANIC, WHITE FEMALE PATIENT, WEIGHING 90KG RECEIVED A BIOZORB DEVICE IMPLANT ON (B)(6) 2024. IT WAS FURTHER REPORTED THAT THE PATIENT HAS EXPERIENCED INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE SHARP PAINS, SWELLING, AND RADIATION FIBROSIS. ADDITIONALLY, IT IS REPORTED THAT THE PATIENT IS CURRENTLY UNDERGOING PHYSICAL THERAPY FOR PAIN, SWELLING AND SPASMS. PATIENT REPORTED MEDICATIONS INCLUDE: ALBUTEROL, AMLODIPINE BESYLATE, ASPIRIN, ATENOLOL, CALCIUM, DANDELION TEA, GLIPIZIDE, HYDRALAZINE, HYDROCHLOROTHIAZIDE, IRON, LOSARTAN, MELOXICAM, METFORMIN, MULTIVITAMIN, TIZANIDINE, VITAMIN D3, VITAMIN E. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Breast Discomfort/Pain; Fibrosis; Swelling/ Edema

  MAUDE report 22708355 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 49-YEAR-OLD, HISPANIC, WHITE FEMALE, WEIGHING 83KG, RECEIVED A BIOZORB DEVICE IMPLANT ON (B)(6) 2022. IT WAS FURTHER REPORTED THAT THE PATIENT HAS EXPERIENCED INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE EXTREME PAIN IN THE RIGHT BREAST. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 22706729 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB DEVICE IMPLANT ON (B)(6) 2024. IT WAS FURTHER REPORTED THAT THE PATIENT HAS EXPERIENCED INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE PAIN AND SEROMA. ADDITIONALLY, IT IS REPORTED THAT THE PATIENT HAD ADDITIONAL SURGERY TO HAVE THE DEVICE REMOVED ON (B)(6) 2024. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Abnormal scarring; Breast Discomfort/Pain; Seroma

  MAUDE report 22706037 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB DEVICE IMPLANT ON (B)(6) 2024. IT WAS FURTHER REPORTED THAT THE PATIENT HAS EXPERIENCED INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE CONSTANT PAIN, SCARRING, SENSITIVITY, AND FAILURE TO REABSORB. ADDITIONALLY, IT IS REPORTED THAT THE PATIENT HAD ADDITIONAL SURGERY TO HAVE THE DEVICE REMOVED ON (B)(6) 2024. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Abnormal scarring; Breast Discomfort/Pain

  MAUDE report 22705417 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HOLOGIC HAS RECEIVED CORRESPONDENCE ARISING FROM LITIGATION. THE ADDITIONAL MEDICAL INFORMATION PROVIDED, REVEALED THE LOT NUMBER 23G31RH OF THE DEVICE. ON (b)(6), 2025 THE PATIENT REPORTED CHRONIC TENSE BREAST AND A SEROMA ON HER BREAST IN THE LAST 6 MONTHS. NO OTHER RELEVANT INFORMATION WAS PROVIDED.THIS REPORT IS BEING SUBMITTED PURSUANT TO 21 CFR PART 803 BASED ON INFORMATION MADE AVAILABLE TO HOLOGIC THROUGH LITIGATION. CONSISTENT WITH 21 CFR 803.16, THE SUBMISSION OF THIS REPORT IS NOT INTENDED, AND SHALL NOT BE CONSTRUED, AS AN ADMISSION, ACKNOWLEDGMENT, OR CONFIRMATION BY HOLOGIC THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

  Patient problems: Bacterial Infection; Breast Discomfort/Pain; Breast Mass; Erythema; Seroma; Swelling/ Edema

  MAUDE report 22535493 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB DEVICE IMPLANT ON (B)(6) 2021. FURTHER REPORTED IS THAT THE PATIENT HAS EXPERIENCED INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE A HARD LUMP, SEVERE PAIN, DISCOMFORT, DEFORMITY, IRRITATION, INFECTION, SLEEP DYSFUNCTION AND SWELLING. IT IS REPORTED THAT THE BIOZORB DEVICE WAS REMOVED ON OR AROUND (B)(6) 2025. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Bacterial Infection; Breast Discomfort/Pain; Breast Mass; Deformity/ Disfigurement; Skin Inflammation/ Irritation; Sleep Dysfunction; Swelling/ Edema

  MAUDE report 22364627 ↗