BioZorb F0303Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 15420045514003), received between Sep 5, 2023 and May 25, 2026 — classified as 18 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (4 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. How this data works · Data updated Oct 13, 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 · 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMay 25, 2026Adverse Event Without Identified Device or Use Problem

  HOLOGIC HAS RECEIVED CORRESPONDENCE ARISING FROM LITIGATION. THE LITIGATION ALLEGES THAT A 53-YEAR-OLD PATIENT WAS IMPLANTED ON (B)(6) 2024 WITH A BIOZORB MARKER FOLLOWING A SURGICAL PROCEDURE FOR A RIGHT BREAST LUMPECTOMY. ON (B)(6) 2025 PATIENT PRESENTED WITH CONCERNS RELATED TO THE RIGHT BREAST TISSUE PAIN ASKING TO BE EVALUATED FOR INFECTION. PATIENT ENDORSED PRESENCE OF RIGHT BREAST PAIN SINCE (B)(6) 2024. ON (B)(6) 2025 THE PATIENT UNDERWENT A SURGICAL INTERVENTION FOR BIOZORB REMOVAL. THE IMPLANT WAS FOUND PARTIALLY ABSORBED, AND IN 2 SEPARATE PIECES WHICH WERE REMOVED FROM THE SURROUNDING BREAST TISSUE. 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 25271156 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  HOLOGIC HAS RECEIVED CORRESPONDENCE ARISING FROM LITIGATION. THE LITIGATION ALLEGES THAT A 68-YEAR-OLD PATIENT WAS IMPLANTED ON (B)(6) 2023 WITH A BIOZORB MARKER FOLLOWING A SURGICAL PROCEDURE FOR A RIGHT BREAST LUMPECTOMY. ON (B)(6) 2024, THE PATIENT REPORTED FOCAL PAIN AT THE RIGHT BREAST LEVEL. 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 25159208 ↗
• InjuryDec 29, 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) 2022, "THE BIOZORB IMPLANT WAS PROBLEMATIC FROM BEGINNING. BREAST INCISION WOULD NOT HEAL - WHICH DELAYED RADIATION. THEN - PAINFUL ALL THE TIME. EMOTIONALLY FELT LIKE CANCER LUMP WAS NEVER REMOVED. REQUESTED ITS REMOVAL ONLY TO BE REASSURED IT WOULD DISSOLVE -ADVISED TO BE PATIENT. FINALLY, THE DOCTOR AGREED FOR IT TO BE REMOVED SURGICALLY." ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT IN WHICH IT WAS REPORTED THAT THE SURGICAL INCISION SITE WOULD NOT HEAL AFTER TRYING THREE ANTIBIOTICS, RESULTING IN THE PATIENT'S RADIATION TREATMENTS BEING DELAYED BY ALMOST A MONTH. THE PATIENT FURTHER REPORTS A LUMP IN THE EXACT LOCATION OF HER PREVIOUS CANCER THAT WAS PAINFUL TO TOUCH. IT IS REPORTED THAT THE BIOZORB DEVICE WAS SURGICALLY REMOVED ON (B)(6) 2025. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Breast Mass; Impaired Healing

  MAUDE report 23915498 ↗
• InjuryApr 29, 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 ON (B)(6) 2023, THE PATIENT LATER REPORTED THAT SHE EXPERIENCED PAIN, INFECTIONS, SCARRING, SWELLING, FLUID BUILDUP, AND SHE HAS EXPERIENCED LYMPHEDEMA, AND AN ABSCESS IN HER LEFT BREAST. ADDITIONALLY IT WAS REPORTED THAT SHE SUFFERS FROM CHRONIC PAIN, SCARRING AND INFECTIONS AT THE SITE OF THE IMPLANTATION. PATIENT IS ACTIVELY SEEKING FURTHER TREATMENT AND ANTICIPATES THE NEED FOR ADDITIONAL SURGERY TO REMOVE THE BIOZORB. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Abscess; Bacterial Infection; Breast Discomfort/Pain; Scar Tissue

  MAUDE report 21930659 ↗
• InjuryApr 7, 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 MARKER ON (B)(6) 2023, THE PATIENT REPORTS THAT SHE EXPERIENCED PAIN, SWELLING AND FLUID BUILD UP AT THE SITE OF IMPLANTATION OF THE DEVICE. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Balance Problems; Breast Discomfort/Pain; Cough; Limb Pain; Neuropathy; Swelling/ Edema

  MAUDE report 21785917 ↗
• InjuryMar 24, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB PLACEMENT ON (B)(6) 2016, AND THAT THE PATIENT STARTED EXPERIENCING PAIN IN HER BREAST AND TREATMENT AREA BECAME RED DURING RADIATION AND THAT ON (B)(6) 2017, THE BIOZORB DISLODGED AND HAD A BAD POSITION UNDER THE DERMIS. A HEMATOMA WAS REPORTED AROUND THE WOUND. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Erythema; Hematoma

  MAUDE report 21678282 ↗
• InjuryMar 24, 2025Fracture; Migration or Expulsion of Device; Migration; Fracture; Migration or Expulsion of Device; Migration

  IT WAS REPORTED THAT ON (B)(6) 2017, A PATIENT HAD A LUMPECTOMY AND A BIOZORB WAS PLACED. IN (B)(6) 2019, THE PATIENT WENT BACK TO THE HOSPITAL WITH REDNESS AND PAIN AT THE SITE OF THE LUMPECTOMY, AND SMALL PINPOINT OF PURULENCE, SUBSEQUENTLY 4 OF THE METAL MARKERS FROM THE BIOZORB HAVE MIGRATED, ANTIBIOTICS WERE GIVEN TO THE PATIENT. ON (B)(6) 2019, THE PATIENT WENT BACK TO THE HOSPITAL WITH A SMALL WOUND (FROM THE BIOZORB TO THE SKIN SURFACE), PART OF THE BIOZORB MIGRATED OUT OF THE WOUND. HEMOLYTIC STREP GREW UP. ON (B)(6) 2019, THE PATIENT HAD THE BIOZORB REMOVED. ANTIBIOTICS WERE CONTINUED ALONG WITH WOUND PACKING UNTIL (B)(6) 2019. PATIENT IS DOING WELL AND WOUND IS WELL-HEALED.

  Patient problems: Breast Discomfort/Pain; Erythema; Purulent Discharge

  MAUDE report 21675952 ↗
• InjuryMar 24, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT ON AN UNKNOWN DATE A PATIENT RECEIVED A BIOZORB DEVICE, BUT 4 WEEKS POST OP, THE BIOZORB DEVICE HAD TO BE REMOVED DUE TO CULTURED INFECTION AND FRACTURE OF THE DEVICE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION WERE NOT RESPONDED.

  Patient problems: Bacterial Infection

  MAUDE report 21674914 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A PHYSICIAN THAT A PATIENT WAS IMPLANTED WITH A BIOZORB DEVICE ON (B)(6) 2017 AND WAS TREATED WITH RADIATION + BOOST FROM (B)(6) 2018 UP UNTIL (B)(6) 2018. THE PHYSICIAN REPORTED THAT THE DEVICE WAS REMOVED ON (B)(6) 2018. THE PHYSICIAN WAS CONTACTED BY EMAIL AND RESPONDED THAT HE BELIEVED THAT HE WAS USING A SIZE TOO LARGE AND HAD CORRECTED THE PROCEDURES BY USING A SMALLER BIOZORB SIZE.

  Patient problems: Insufficient Information

  MAUDE report 21674841 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED A BIOZORB MARKER ON (B)(6) 2018 AND HAD TO UNDERGO A RE-EXCISION PROCEDURE ON AN UNKNOWN DATE. THE PHYSICIAN REPORTED THAT HE WAS EVALUATING THE REMOVAL OF THE DEVICE. NO FURTHER INFORMATION AVAILABLE. MULTIPLE ATTEMPTS TO OBTAIN INFORMATION NOT RESPONDED. THE PHYSICIAN REPORTED THAT HE MIGHT BE USING TOO LARGE SIZES.

  Patient problems: Insufficient Information

  MAUDE report 21674839 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A BIOZORB PLACED ON (B)(6) 2017. ON (B)(6) 2017, DURING RE-EXCISION OF THE MARGINS, THE PHYSICIAN NOTED CELLULITIS AND DEFORMATION OF THE BREAST AND INCISION & DRAINAGE (I&D) WAS PERFORMED. CULTURE WAS POSITIVE FOR STAPH AND BACILLUS AND THE BIOZORB WAS REMOVED. THE PATIENT WAS STARTED ON ANTIBIOTICS AND THE WOUND WAS NOTED TO BE FULLY HEALED ON (B)(6) 2017.

  Patient problems: Bacterial Infection; Seroma; Unspecified Reproductive System or Breast Problem

  MAUDE report 21650441 ↗
• MalfunctionMar 20, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT A REGISTRY PATIENT PRESENTED WITH CALCIFICATIONS ALONG THE SPIRAL PORTION OF THE DEVICE APPROXIMATELY 2 YEARS POST IMPLANTATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21650435 ↗
• InjuryOct 16, 2024Adverse 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 ON (B)(6) 2023, LATER PATIENT EXPERIENCED SEROMA, DISCOMFORT AND EVENTUAL ABSCESS. BIOZORB WAS REMOVED ON (B)(6) 2024. NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Breast Discomfort/Pain; Calcium Deposits/Calcification; Seroma; Sleep Dysfunction

  MAUDE report 20465640 ↗
• InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT ON (B)(6) 2020, A BIOZORB PROCEDURE WAS PERFORMED AND THE PATIENT REPORTED SUFFERING FROM A HARD, PAINFUL LUMP AND REDDENING OF THE SKIN NEAR THE AREA WHERE THE BIOZORB DEVICE WAS IMPLANTED. THE PATIENT ALSO REPORTED SUFFERING FROM ITCHINESS, DISCOMFORT, AND PAIN THAT IS WORSENED BY TOUCH. THE PATIENT REPORTED SUFFERING FROM PROBLEMS SLEEPING AND SHOWERING. ALSO REPORTED THAT BELIEVES THAT THE DEVICE HAS MIGRATED INTO HER BREAST AND THAT IT HAS NOT BEEN PROPERLY ABSORBED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Breast Mass; Erythema; Sleep Dysfunction

  MAUDE report 18814983 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A BIOZORB IMPLANTED ON (B)(6) 2023 AND THE PATIENT REPORTED SUFFERING FROM A HARD, PAINFUL LUMP AT THE SITE OF THE BIOZORB DEVICE. ADDITIONALLY, THE PATIENT REPORTED SUFFERING FROM DISCOMFORT, ITCHING, AND STABBING PAIN WHEN MOVING. IT WAS REPORTED THAT THE BIOZORB DEVICE HAS NOT ABSORBED AND IS STILL PALPABLE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Itching Sensation

  MAUDE report 18025252 ↗
• InjurySep 6, 2023Material Fragmentation; Adverse Event Without Identified Device or Use Problem; Migration; Material Fragmentation; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021 A BIOZORB WAS IMPLANTED IN THE PATIENT AND THE PATIENT REPORTED SUFFERING FROM A HARD, PAINFUL, PALPABLE LUMP WHERE THE BIOZORB WAS IMPLANTED. THE PATIENT ALSO REPORTED SUFFERING FROM EXCRUCIATING PAIN, DIFFICULTY SLEEPING, LIMITED MOBILITY, SWELLING, NECROSIS, AND SEROMA AT THE SITE OF THE BIOZORB DEVICE. IT WAS REPORTED THAT THE BIOZORB DEVICE DID NOT ABSORB, INSTEAD THE DEVICE MIGRATED AND WAS PRESSING UP AGAINST THE PATIENT¿S SKIN, NEARLY PROTRUDING THROUGH HER BREAST WHICH IS NOW DEFORMED DUE TO HER COMPLICATIONS FROM THE DEVICE AND REMOVAL PROCEDURE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Abnormal scarring; Bacterial Infection; Breast Discomfort/Pain; Breast Mass; Burning Sensation; Deformity/ Disfigurement; Erythema; Necrosis; Seroma; Skin Erosion; Sleep Dysfunction; Swelling/ Edema

  MAUDE report 17690558 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6), 2016 A BIOZORB WAS IMPLANTED IN THE PATIENT, AND THE PATIENT REPORTED SUFFERING FROM A HARD, PAINFUL, PALPABLE LUMP WHERE THE BIOZORB WAS IMPLANTED. THE PATIENT REPORTED SUFFERING FROM PAIN, TENDERNESS, SENSITIVITY, AND A CRAMPING SENSATION AND DEVELOPED PASH AT THE SITE OF THE BIOZORB. ALSO WAS REPORTED THAT THE BIOZORB DEVICE DID NOT ABSORB AND REQUIRED REMOVAL. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 17690417 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A BIOZORB MARKER IN (B)(6) 2018. PATIENT IS COMPLAINING THAT SHE HAS PAIN THAT SENDS SHOCK WAVE THROUGH HER THAT SHE IS HAVING ISSUES WITH JOGGING AND SLEEPING. SHE REPORTS THAT HER BREAST IS VERY TENDER AND SORE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Sleep Dysfunction

  MAUDE report 17686030 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 A BIOZORB WAS IMPLANTED IN THE PATIENT, AND THE PATIENT REPORTED THAT SUFFERS FROM PERSISTENT, SHARP, STABBING PAIN IN HER BREAST. IT WAS REPORTED THAT THE BIOZORB HAS NOT DISSOLVED AND INSTEAD CREATED A LARGE, HARD LUMP, ALSO THAT THE AREA OF THE BIOZORB IS SENSITIVE TO THE TOUCH. THE PATIENT REPORTED THAT HAS ENDURED INFECTIONS CAUSED BY THE BIOZORB AND SHE ALSO NOW HAS SPIDER VEINS ON HER LEFT BREAST. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Erythema; Wound Dehiscence

  MAUDE report 17684245 ↗