BioZorb Marker F0202Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00851766006009), received between Sep 5, 2023 and Mar 20, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Migration” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2026

  I RECEIVED THE BIOZORB WHILE HAVING A LUMPECTOMY FOR MALIGNANT DUCTAL CARCINOMA OF THE RIGHT BREAST. SHORTLY AFTER SURGERY BEGAN HAVING DISCOMFORT AND WAS TOLD OVER AND OVER THAT THE IMPLANT WOULD DISSOLVE. FAST FORWARD TO TODAY (B)(6) 2026 I HAVE SWELLING, PAIN, DISFIGURATION AS WELL AS RASH IN THE AREA. RECENT MAMMOGRAM REVEALS IT IS STILL COMPLETELY INTACT. SCHEDULED FOR REMOVAL (B)(6) 2026.

  Patient problems: Deformity/ Disfigurement; Discomfort; Pain; Rash; Swelling/ Edema

  MAUDE report 24649215 ↗
• InjurySep 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) 2019. IT WAS FURTHER REPORTED THAT THE PATIENT HAS EXPERIENCED INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE PAIN, TENDERNESS, SENSITIVITY, A HARD MASS AND FAILURE TO REABSORB. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Breast Mass; Deformity/ Disfigurement

  MAUDE report 23179264 ↗
• InjuryMar 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LUMPECTOMY WITH BIOZORB PLACEMENT ON (B)(6) 2017. THE PATIENT RETURNED FOR A REQUIRED RE-EXCISION AND WAS THEN FOUND TO HAVE A PSEUDOMONAS INFECTION. THE PATIENT WAS TREATED AND HEALED.

  Patient problems: Bacterial Infection

  MAUDE report 21615639 ↗
• InjuryMar 16, 2025Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT THE PATIENT HAD A LUMPECTOMY WITH BIOZORB PLACEMENT ON (B)(6) 2016. A RE-EXCISION DUE TO POSITIVE MARGINS WAS PERFORMED ON (B)(6) 2017 WHERE THE BIOZORB WAS REMOVED AND PLACED BACK IN AFTER RE-EXCISION. ON (B)(6) 2017 A CT SCAN SHOWED THE BIOZORB INTACT. A SECOND CT SCAN COMPLETED ON (B)(6) 2017 SHOWED THE BIOZORB IN TWO SEPARATE PIECES, HALF OF IT WAS IN THE TUMOR BED AND THE OTHER MIGRATED OUT INTO SEROMA. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Seroma

  MAUDE report 21615638 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LUMPECTOMY WITH BIOZORB PLACEMENT ON (B)(6) 2016. APPROXIMATELY 5 WEEKS AFTER SURGERY THE PATIENT PRESENTED WITH SWOLLEN, PUFFY, AND RED BREAST WITH MILD SEROUS DRAINAGE. SEROUS FLUID CULTURE GREW STAPHYLOCOCCUS AUREUS. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND AS OF (B)(6) 2016, THE PATIENT WAS IMPROVING. THE BIOZORB DEVICE WAS LEFT IN PLACE.

  Patient problems: Erythema; Inflammation; Seroma; Swelling/ Edema

  MAUDE report 21312399 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 A BIOZORB WAS IMPLANTED, AND THE PATIENT REPORTED SUFFERING FROM A HARD, PAINFUL LUMP NEAR THE SITE OF THE BIOZORB DEVICE. THE PATIENT ALSO REPORTED SUFFERING FROM SWELLING, DISCOMFORT, PAIN, ITCHING, AND A BURNING SENSATION AT AND AROUND THE SITE OF THE BIOZORB DEVICE. THE PATIENT ALSO REPORTED BELIEVING THAT THE BIOZORB DEVICE HAS FAILED TO PROPERLY ABSORB. NO ADDITIONAL INFORMATION AVAILABLE.

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

  MAUDE report 18191507 ↗
• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, A BIOZORB WAS IMPLANTED, AND THE PATIENT REPORTED SUFFERING FROM A HARD, PAINFUL LUMP NEAR THE SITE WHERE THE BIOZORB DEVICE WAS IMPLANTED, DEFORMITY, SCARRING, AND REDDENING OF THE SKIN WHERE THE BIOZORB DEVICE WAS IMPLANTED. THE PATIENT REPORTED ALSO SUFFERING FROM SENSITIVITY, ITCHING, SWELLING, AND PAIN THAT MAKE SLEEPING DIFFICULT AND MAMMOGRAMS SEVERELY PAINFUL. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement; Erythema; Itching Sensation

  MAUDE report 18105569 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB IMPLANTATION ON (B)(6) 2019. THE PATIENT REPORTED THAT SHE SUFFERS FROM A HARD, PAINFUL LUMP AT THE SITE OF IMPLANTATION. ADDITIONAL PATIENT REPORTED THAT SHE SUFFERS FROM SWELLING, INFECTIONS, TENDERNESS, DEFORMITY, AND PAIN THAT AFFECTS HER DAILY LIFE INCLUDING DIFFICULTY TO SLEEP. NO OTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 18025677 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED THAT ON (B)(6) 2018, A BIOZORB WAS IMPLANTED IN A PATIENT AND THE PATIENT REPORTED SUFFERING FROM A LUMP IN HER LEFT BREAST IN THE AREA OF THE BIOZORB, WHICH HAD MIGRATED FROM ITS ORIGINAL LOCATION. IT WAS REPORTED THAT THE BIOZORB CAUSES CONSTANT ITCHING, RASHES, STABBING PAIN, AND DISCOMFORT. THE PATIENT REPORTED THAT HAS DISCUSSED EXPLANT SURGERY OF BIOZORB BUT IS HESITANT TO GO THROUGH ANOTHER SURGERY. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Erythema; Itching Sensation; Rash; Sleep Dysfunction

  MAUDE report 17686248 ↗