BioZorb Marker F0303Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00851766006023), received between Sep 5, 2023 and Apr 30, 2025 — classified as 8 injuries.

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

• InjuryApr 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 ON (B)(6) 2018, LATER THE PATIENT REPORTED EXPERIENCED PAIN, PALPABILITY, DISCOMFORT, EDEMA, HARDENING OF THE BREAST AND FAILURE TO RESORB. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Swelling/ Edema

  MAUDE report 21938166 ↗
• InjuryMar 19, 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 PLACEMENT DURING A LUMPECTOMY ON (B)(6) 2016. ON (B)(6) 2017, DRAINAGE WAS PERFORMED AT THE INCISION SITE. PATIENT RECEIVED RADIATION IN (B)(6) 2017 AS PART OF THE TREATMENT. END OF (B)(6) 2017, PATIENT CAME BACK TO THE OFFICE DUE TO DRAINAGE AND DEHISCENCE AND THE BIOZORB WAS EXPOSED AT THE WOUND. THE PATIENT WAS PLACED ON ANTIBIOTICS AND WOUND CARE. ON (B)(6) 2017, THE BIOZORB WAS REMOVED. POSTERIORLY THE WOUND WAS REPORTED AS HEALING WELL.

  Patient problems: Bacterial Infection; Fluid Discharge; Medical device site infection; Wound Dehiscence

  MAUDE report 21641447 ↗
• InjuryJan 15, 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 AND BIOZORB PLACEMENT ON (B)(6)2016. THE PATIENT DEVELOPED A LARGE HEMATOMA POSTOP WITH MANUAL LYMPHATIC DRAINAGE OF THE BREAST. CHEMOTHERAPY WAS COMPLETED ON (B)(6), 2016. THE PATIENT PRESENTED ON (B)(6) 2016 WITH ACUTE BREAST REDNESS AND A WOUND, CULTURES WERE NEGATIVE AND A WOUND VAC WAS STARTED. THE WOUND WORSENED AND THE BIOZORB COULD BE SEEN IN THE WOUND AND WAS REMOVED DURING WOUND TREATMENT ON (B)(6) 2016. NO FURTHER COMPLICATIONS WERE REPORTED, AND THE WOUND WAS HEALING WELL.

  Patient problems: Erythema; Fluid Discharge; Hematoma; Seroma

  MAUDE report 21159832 ↗
• InjuryJan 15, 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. THE PATIENT PRESENTED 6 WEEKS LATER WITH ERYTHEMA ON LOWER PORTION OF BREAST, CULTURED POSITIVE FOR PEPTO STREPTOCOCCUS. ANTIBIOTIC TREATMENT AND ASPIRATIONS WERE COMPLETED WITHOUT IMPROVEMENT. THE BIOZORB DEVICE WAS REMOVED ON (B)(6) 2016. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Bacterial Infection; Erythema

  MAUDE report 21158367 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN 85-YEAR-OLD PATIENT RECEIVED A BIOZORB MARKER (F0303) ON (B)(6) 2019, DURING A LUMPECTOMY DUE TO A PREVIOUS BIOPSY ON (B)(6) 2019 THAT REVEALED TRIPLE NEGATIVE IDC. PATIENT RECEIVED CHEMOTHERAPY DUE TO THE TRIPLE NEGATIVE STATUS OF HER TUMOR, PATIENT RECEIVED ONE TREATMENT OF CHEMO AND REFUSED THE REMAINDER OF THE COURSE, ADDITIONALLY PATIENT RECEIVED RADIOTHERAPY FROM (B)(6) 2019 UP UNTIL (B)(6) 2019. IT WAS REPORTED THAT FOLLOWING HER RADIATION TREATMENT AND ONE TREATMENT OF CHEMO, THE PATIENT DEVELOPED AN INFECTION 11 MONTH POST-SURGERY. PATIENT PRESENTED TO A PHYSICIAN CLINIC ON (B)(6) 2020, WITH RED AREA TO THE LUMPECTOMY SITE AND A SMALL WHITE PIMPLE ON THE LATERAL SIDE OF THE INCISION. THE PHYSICIAN ATTEMPTED ASPIRATION AND FILLED A 3-CC SYRINGE WITH PUS FROM THE AREA. THE PHYSICIAN APPLIED MILD PRESSURE TO THE AREA AND MORE PUS CAME OUT. SHE ASPIRATED A TOTAL OF 8 CC OF PUS. THE EXUDATE WAS SENT FOR CULTURE AND GREW KLEBSIELLA. PATIENT WAS STARTED ON BACTRIM AND SENT FOR IMAGING. THE PHYSICIAN REPORTED THAT THE BIOZORB APPEARED BLURRED ON THE DIAGNOSTIC ULTRASOUND BUT OTHERWISE UNREMARKABLE. PATIENT WAS SEEN ON (B)(6) 2020, AND ADDITIONAL 3.5 CC OF P

  Patient problems: Bacterial Infection; Erythema

  MAUDE report 20758670 ↗
• InjurySep 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 58 YEARS OLD 86 KG FEMALE PATIENT UNDERWENT A PARTIAL MASTECTOMY WITH TWO BIOZORB PLACEMENTS ON (B)(6) 2019. PATIENT REPORTED THAT 1 DAY AFTER THE SURGERY 1 BREAST WAS WARM AND RED. LATER ON AN UNKNOWN DATE PATIENT HAD IRRIGATION AND DEBRIDEMENT AND STARTED ON ANTIBIOTICS. PATIENT COMPLAINED OF BREAST SWELLING IN DRAINAGE LEADING TO REMOVAL OF THE BIOZORB ON (B)(6) 2019. PATIENT HAD A HISTORY OF HYPERTENSION. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Erythema; Swelling/ Edema; Wound Infection

  MAUDE report 20118302 ↗
• InjurySep 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 41 YEARS OLD, 93 KG FEMALE PATIENT HAD A PARTIAL MASTECTOMY WITH BIOZORB PLACEMENT ON (B)(6) 2017. BIOZORB WAS NOTED TO BE PALPABLE LATER. THE PATIENT RETURNED ON (B)(6) 2018, TO THE OR TO REMOVE BIOZORB AND EXCISIONAL BIOPSY. UNABLE TO DO A CORE BIOPSY DUE TO THE BIOZORB. PATIENT REPORTED A HISTORY OF HYPOTHYROIDISM. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 20117944 ↗
• 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) 2021 A BIOZORB WAS IMPLANTED IN THE PATIENT, AND THE PATIENT REPORTED SUFFERING FROM A HARD, PAINFUL LUMP WHERE THE BIOZORB DEVICE WAS IMPLANTED. IT WAS REPORTED THAT SUFFERS FROM TENDERNESS, DISCOMFORT, AND FREQUENT, SHARP, ¿BEE STING¿ LIKE PAIN AT THE SITE OF THE DEVICE. WHILE WEARING A BRA, THE PATIENT REPORTED TO SUFFERS FROM THIS SHARP PAIN SEVERAL TIMES PER DAY AND SHE SUFFERS EVERY NIGHT IF SHE SLEEPS ON HER LEFT SIDE. THE PATIENT ALSO REPORTED SUFFERING FROM AN UNCOMFORTABLE PULLING SENSATION IN HER BREAST AT THE SITE OF THE DEVICE ANYTIME SHE REACHES UPWARDS, FOR EXAMPLE, WHEN WASHING HER HAIR. IN ADDITION, THE PATIENT REPORTED THAT THE BIOZORB DEVICE HAS NOT BEEN ABSORBED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Breast Mass; Deformity/ Disfigurement; Hyperpigmentation; Sleep Dysfunction

  MAUDE report 17686771 ↗