BioZorb LP Marker F0331Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00851766006085), received between Jan 15, 2025 and May 22, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  HOLOGIC HAS RECEIVED CORRESPONDENCE ARISING FROM LITIGATION. THE LITIGATION ALLEGES THAT A 59 YEAR-OLD PATIENT WAS IMPLANTED ON (B)(6) 2018 WITH A BIOZORB MARKER FOLLOWING A SURGICAL PROCEDURE FOR A LEFT BREAST LUMPECTOMY. ON (B)(6 2025 PATIENT PRESENTED WITH NEW TENDERNESS AND A CHRONIC MASS AT THE LEFT BREAST LEVEL. SHE NOTED TENDERNESS WITH PALPATION, OTHERWISE DOES NOT HURT. A DIAGNOSTIC MAMMOGRAM AND ULTRASOUND PERFORMED ON (B)(6) 2020 DEMONSTRATED CHRONIC SEROMA ON THE LEFT BREAST. A BIOPSY OF THE LEFT BREAST MASS ON (B)(6) 2023 FOUND FAT NECROSIS AND BENIGN 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; Breast Mass; Necrosis; Seroma

  MAUDE report 25255185 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA MEDWATCH REPORT MW5175639 THAT A 52-YEAR-OLD NON-HISPANIC WHITE FEMALE PATIENT WEIGHING 73KG 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 AND INFECTIONS. REPORTED MEDICATIONS INCLUDE: CASCARA SAGRADA, FISH OIL, LEVOTHYROXINE, LYCOPENE, MAGNESIUM, MELATONIN, NALTREXONE, SENNA, SERUM EYE DROPS, VITAMIN C AND VITAMIN D. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Bacterial Infection; Breast Discomfort/Pain; Rash

  MAUDE report 23349171 ↗
• InjuryFeb 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 ON (B)(6) 2018, THE PATIENT REPORTED SUFFERED FROM IRRITATION, REDNESS, PAIN, RASH, SWELLING, INFECTION, PROTRUSION AND ABSCESS AT THE SITE. IN 2018 PATIENT DEVELOPED SEROMA AT THE SITE OF THE IMPLANTATION THAT REQUIRED ASPIRATION. IN (B)(6) 2024, PATIENT DEVELOPED ANOTHER CYST THAT REQUIRED SEVERAL ASPIRATIONS, WOUND VAC TREATMENTS AND SURGICAL REMOVAL. DUE TO THE CHRONIC INFECTION AT THE SITE, THE PATIENT HAD THE BIOZORB REMOVED ON (B)(6) 2024. FOLLOWING REMOVAL OF THE DEVICE THE PATIENT HAD TO RECEIVE ADDITIONAL TREATMENT TO DRAIN THE ABSCESS. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Abscess; Bacterial Infection; Erythema; Rash; Seroma; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 21471058 ↗
• InjuryJan 15, 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) 2016. THE PATIENT PRESENTED ONE WEEK LATER WITH PAIN AND SPASMS OF THE PEC MUSCLE WHEN SHE MOVED. THE BIOZORB WAS REMOVED ON (B)(6) 2016 WITH NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Breast Discomfort/Pain; Cramp(s) /Muscle Spasm(s)

  MAUDE report 21159833 ↗