BioZorb F0404Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 15420045514058), received between Sep 6, 2023 and Apr 30, 2025 — classified as 6 injuries.

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 6 most recent of 6 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) 2023. LATER THE PATIENT REPORTED SHE EXPERIENCED PAIN, A HARD PAINFUL PALPABLE LUMP AND FAILURE TO RESORB FROM THE DEVICE. NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 21938209 ↗
• 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 DEVICE ON (B)(6) 2016, THE PATIENT REPORTED THAT SHE HAS EXPERIENCED PAIN, SWELLING AT THE SITE OF IMPLANTATION AND REQUIRED TO UNDERGO RADIATION TREATMENT AS A RESULT OF THE COMPLICATIONS. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Swelling/ Edema

  MAUDE report 21785788 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A LUMPECTOMY WITH A BIOZORB PLACED ON (B)(6) 2018. THE PATIENT EXPERIENCED A CHRONIC SEROMA SURROUNDING THE DEGRADED DEVICE. THE PATIENT EXPERIENCED WOUND-HEALING ISSUES THAT STARTED AFTER THE SURGERY AND MARGINS RETURNED POSITIVE ON PATHOLOGY. THE PATIENT RECEIVED RE-EXCISION SURGERIES AND THE BIOZORBS WERE REPLACED. AFTER A FEW MONTHS THE PATIENT WAS SEEN DUE TO NON-HEALING WOUNDS AND OOZING. RADIATION HAD NOT STARTED YET. EVENTUALLY THE BIOZORB WAS REMOVED ON (B)(6) 2018.

  Patient problems: Bacterial Infection; Impaired Healing; Seroma

  MAUDE report 21675754 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A ROUTINE RE-EXCISION PROCEDURE, THE SURGEON CHOSE TO REMOVE THE DEVICE THAT WAS "FLAT" AND REPLACED IT WITH A NEW DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE WAS RETURNED FOR INVESTIGATION, AND IT WAS DETERMINED THAT THE DEVICE HAD DEFORMED IN-SITU, THERE WAS NO SIGN OF DEVICE FRACTURE AND THAT THE CLIPS WERE IN PROPER LOCATION ON DEVICE. THE BIOZORB IS EXPECTED TO LOSE INTEGRITY AS PART OF THE NORMAL DEGRADATION PROCESS AND HAS FLEXIBILITY TO ACCOMMODATE MOVEMENT AND CONTRACTURES OF THE SURROUNDING SITE. BECAUSE THE DEVICE IS SUTURED IN PLACED THE CLIPS ARE STILL HELD IN A 3-DIMENSTIONAL ARRAY EVEN IF THE SPACER CONFIGURATION CHANGES AS A RESULT OF DEGRADATION/RESORPTION OR TISSUE MOVEMENT, THEREFORE THIS WAS NOT CONSIDERED A FAILURE OF THE DEVICE TO MEET THE DESIGN CRITERIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21157839 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 70 YEAR OLD FEMALE PATIENT UNDERWENT A NEEDLE LOCALIZED LUMPECTOMY WITH BIOZORB PLACEMENT. ON 2023, THE PATIENT REPORTED TO HAVE PAIN, ERYTHEMA AND SWELLING TO THE LEFT BREAST AREA ASPIRATED UNDER ULTRASOUND WHICH GREW STAPHYLOCOCCUS CAPRAE. THE PATIENT WAS TREATED WITH ANTIBIOTICS WITH NO CHANGE. ON A NEW OCCASION THE AREA WAS DRAINED AGAIN, CULTURE SENT OUT WITH NO GROWTH TO INFECTIOUS DISEASE. PATIENT WAS PRESCRIBED KEFLEX, THEN BACTRIM AND ANOTHER ASPIRATION WAS COMPLETED WITH NEGATIVE CULTURES. PATIENT REPORTED ADDITIONAL PAIN WHEN STRETCHING HER ARM, SINCE THEN THE SWELLING HAS GONE DOWN BUT THE AREA REMAINS ERYTHEMATOUS. NO ADDITIONAL INTERVENTION REQUIRED.

  Patient problems: Breast Discomfort/Pain; Erythema; Post Operative Wound Infection; Swelling/ Edema

  MAUDE report 20077336 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMPECTOMY ON (B)(6) 2017 DURING WHICH A BIOZORB WAS IMPLANTED. PATIENT HAD A PRIOR DIAGNOSIS OF LEFT BREAST INVASIVE DUCTAL CARCINOMA. THE PATIENT REPORTED THAT SHE HAD A HARD, PAINFUL LUMP AT THE IMPLANTATION SITE AND THAT THE PATIENT FELT THAT IT GREW LARGER. PATIENT REPORTED THAT SHE COULD NOT SLEEP DUE TO THE PAIN. PATIENT REPORTED THAT IN (B)(6) 2018 SHE DEVELOPED CELLULITIS IN HER BREAST AND SEPSIS WHICH GOT SWOLLEN, PURPLE AND RED AND ADDITIONAL PAIN. IN MARCH 2018 PATIENT HAD A SURGERY TO REMOVED THE BIOZORB, PATIENT REPORTS THAT THE WOUND WOULD NOT HEAL AND HAD TO BE IN AND OUT OF THE HOSPITAL FOR THE NEXT THREE MONTHS. PATIENT REPORTS THAT SHE SUFFERED SEROMA, NECROSIS, INFECTION AND PAIN. IN (B)(6) 2018 PATIENT HAD A SURGERY TO DEBRIDE THE INFECTED AREA OF THE BREAST IN WHICH MUSCLE WAS REMOVED FROM HER BACK TO AID IN HER HEALING. SHE RECEIVED ADDITIONAL CARE FOR ANOTHER 3 MONTHS FOR HER WOUND. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Bacterial Infection; Breast Discomfort/Pain; Burning Sensation; Cellulitis; Erythema; Necrosis; Seroma; Sleep Dysfunction; Swelling/ Edema

  MAUDE report 17695181 ↗