BioZorb F0304Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 15420045514010), received between Dec 5, 2023 and Sep 30, 2025 — classified as 16 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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.

• 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) 2020. IT WAS FURTHER REPORTED THAT THE PATIENT HAS EXPERIENCED INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE PAIN, DISCOMFORT, STIFFNESS, ITCHING, HARDNESS, BURNING AT AND AROUND THE SITE OF THE BIOZORB AND FAILED TO ABSORB. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

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

  MAUDE report 23179197 ↗
• InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A PATIENT RECEIVED A BIOZORB DEVICE. IT IS REPORTED THAT THE PATIENT HAS EXPERIENCE INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE DEFORMITY, VERTIGO, A HARD PAINFUL LUMP, AND IRRITATION. ADDITIONALLY, IT IS REPORTED THAT THE PATIENT'S PAIN WORSENED UPON CONTACT AT THE SITE OF THE BIOZORB, MAKING IT DIFFICULT TO SLEEP. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Breast Discomfort/Pain; Breast Mass; Deformity/ Disfigurement; Skin Inflammation/ Irritation; Sleep Dysfunction

  MAUDE report 22169198 ↗
• InjuryMay 28, 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) 2021. IT IS REPORTED THAT THE PATIENT SUFFERED FROM INJURIES AT AND AROUND THE SITE OF IMPLANTATION WHICH INCLUDE, CHRONIC PAIN, SORENESS, SWELLING, AND FLUID BUILDUP NEAR THE SITE OF THE BIOZORB DEVICE. ADDITIONALLY, IT IS REPORTED THAT THE PATIENT UNDERWENT PHYSICAL THERAPY DUE TO SWELLING AND FLUID BUILDUP NEAR THE SITE OF THE BIOZORB DEVICE. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 22100324 ↗
• InjuryMay 28, 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. IT IS REPORTED THAT THE PATIENT SUFFERED FROM INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE CHRONIC PAIN, SCARRING, AND DISCOMFORT. ADDITIONALLY, IT IS REPORTED THAT THE PATIENT UNDERWENT A REMOVAL OF EXPOSED FOREIGN BODY AND WOUND WASHOUT ON THE RIGHT BREAST DUE TO EVIDENCE OF INFECTION AND FOREIGN BODY EXPOSURE ON (B)(6) 2025. DURING THAT PROCEDURE, THE BIOZORB DEVICE WAS REMOVED AND A CAPSULECTOMY WAS ALSO PERFORMED IN ADDITION TO A TISSUE TRANSFER IN AN ATTEMPT TO MINIMIZE THE CONTOUR DEFORMITY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Abnormal scarring; Bacterial Infection; Breast Discomfort/Pain

  MAUDE report 22100284 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A PATIENT RECEIVED A BIOZORB DEVICE. THE PATIENT REPORTS THAT SHE SUFFERED FROM INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE HEMATOMA, PAIN, SWELLING, REDNESS AND INFECTION. ON (B)(6), 2022, THE PATIENT UNDERWENT A LEFT BREAST WOUND EXPLORATION PROCEDURE AT WHICH TIME BOTH THE HEMATOMA AND BIOZORB DEVICE WERE REMOVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bacterial Infection; Breast Discomfort/Pain; Erythema; Hematoma; Swelling/ Edema

  MAUDE report 21939301 ↗
• 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) 2024, THE PATIENT REPORTED THAT SHE SUFFERED FROM PAIN, DISCOMFORT, RASH, ITCHINESS , MIGRATION, SENSITIVITY AND MIGRATION , DUE TO THE MIGRATION THE DEVICE WAS REPORTED AS EXPLANTED ON (B)(6) 2024. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Itching Sensation

  MAUDE report 21939277 ↗
• InjuryMar 24, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB ON (B)(6) 2020. THE PATIENT RECEIVED RADIATION TREATMENT. INITIALLY THE PATIENT WAS DOING WELL BUT THE PATIENT SHOWED SIGNS OF AN ABSCESS/FLUID THAT REQUIRED TO BE DRAINED. THE DEVICE WAS VISIBLE POST RADIATION. ULTIMATELY THE BIOZORB DEVICE WAS REMOVED ON (B)(6) 2020.

  Patient problems: Abscess; Seroma; Skin Inflammation/ Irritation

  MAUDE report 21678836 ↗
• InjuryMar 24, 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) 2017, DURING A LUMPECTOMY. IT WAS REPORTED THAT THE PATIENT STARTED EXPERIENCING PAIN IN HER BREAST AND THAT THE AREA BECAME RED DURING RADIATION TREATMENTS. IT WAS REPORTED THAT THE BIOZORB WAS REMOVED DURING RECONSTRUCTIVE SURGERY ON (B)(6) 2018, DUE TO CHRONIC INFLAMMATION. THE PATIENT RECEIVED RADIATION FROM (B)(6) 2017.

  Patient problems: Breast Discomfort/Pain; Erythema; Inflammation

  MAUDE report 21678283 ↗
• InjuryMar 24, 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 IN (B)(6) 2018. THE PATIENT REPORTED SHE HAD A POST OPERATIVE SEROMA THAT WAS DRAINED AND SHE WAS GIVEN ORAL ANTIBIOTICS. AFTER THE SEROMA WAS ABSORBED, AN INDENT WAS LEFT IN THE AREA OF THE SURGERY, AND SHE CAN FEEL THE BIOZORB AND IT IS BOTHERSOME TO HER. THE PATIENT IS CONSIDERING HAVING THE BIOZORB REMOVED BUT WANTED TO DISCUSS HER THOUGHTS WITH FOCAL.

  Patient problems: Breast Discomfort/Pain; Seroma

  MAUDE report 21675752 ↗
• MalfunctionMar 24, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT A PHYSICIAN PLACED A BIOZORB DEVICE DURING A LUMPECTOMY PROCEDURE ON (B)(6) 2018, THE PATIENT REQUIRED A RE-EXCISION PROCEDURE ON (B)(6), 2018, DUE TO POSITIVE MARGINS AND DISCOVERED THAT THE DEVICE WAS BROKEN IN PIECES. THE DEVICE WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21675098 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A PREVIOUS HISTORY OF CANCER RECEIVED A LUMPECTOMY DUE TO RECURRENCE IN (B)(6) 2018 WITH A BIOZORB PLACEMENT SHE RECEIVED XRT FOR 33 TREATMENTS. PATIENT PRESENTED ON (B)(6) 2018, WITH CELLULITIS OF THE SURGICAL SITE, WHICH WAS TREATED WITH KEFLEX, AND ON (B)(6) AS WELL WITH IV ANTIBIOTICS, AND THE PATIENT REDNESS WAS IMPROVING. THE PATIENT RECEIVED ASPIRATION OF THE SURGICAL SITE ON (B)(6) 2019, AND WAS SENT FOR CULTURE, WHICH DID NOT REVEAL ANY ORGANISM. ON (B)(6) THE CELLULITIS RESOLVED, AND THE PATIENT WAS DOING WELL.

  Patient problems: Bacterial Infection; Erythema

  MAUDE report 21675090 ↗
• MalfunctionMar 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT A BIOZORB DEVICE THAT WAS PLACED PREVIOUSLY HAD TO BE REMOVED DUE TO A RE-EXCISION SURGERY FOR POSITIVE MARGINS. THE DEVICE WAS FOUND BROKEN IN 2 PIECES AND NOT REPLACED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21660169 ↗
• MalfunctionMar 20, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PATIENT HAD A BIOZORB IMPLANTED ON (B)(6) 2017. THE PHYSICIAN REMOVED THE DEVICE SO THAT TISSUE COULD BE RE-EXCISED ON (B)(6) 2017, AND NOTED THE COIL WAS IN TWO PIECES. THE ORIGINAL DEVICE WAS LEFT IN PLACE AFTER THE RE-EXCISION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21650439 ↗
• InjuryMar 19, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A LUMPECTOMY PROCEDURE WITH PLACEMENT OF F0304 DEVICE ON (B)(6) 2017. A NEW SURGERY REQUIRED DUE TO ADDITIONAL POSITIVE MARGINS ON (B)(6) 2017 AND IT WAS NOTED THAT THE DEVICE WAS IN 2 DISTINCT PIECES OF ROUGHLY EQUAL SIZE IN SITU. THE DEVICE WAS REMOVED AND A F0303 WAS USED TO REPLACED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21645119 ↗
• 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 DEVICE DURING A LUMPECTOMY ON (B)(6) 2017. ON (B)(6) 2017, PATIENT REPORTED THAT THE INCISION WOUND WAS DRAINING EXCESSIVE AMOUNTS OF YELLOW/ORANGE DISCHARGE, DRAIN WAS PLACED TO LUMPECTOMY SITE, CULTURES TAKEN AND PATIENT STARTED ON ANTIBIOTICS. ON (B)(6) 2017, CULTURES REVEALED SCANT STAPH AUREUS AND MINIMAL REDNESS OBSERVED, DRAIN WITH SCAN DRAINAGE AND WOUND APPEARED HEALING, ANTIBIOTICS WERE CONTINUED. PATIENT CONTINUED WITH DRAIN AND ANTIBIOTIC TREATMENT FOR WOUND AND PATIENT REPORTED DID NOT WANT THE BIOZORB REMOVED AS SHE WAS STARTING CHEMOTHERAPY.

  Patient problems: Bacterial Infection; Fluid Discharge

  MAUDE report 21645075 ↗
• 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 PARTIAL MASTECTOMY AND BIOZORB PLACEMENT ON (B)(6)2015. IN (B)(6) 2016, THE PATIENT COMPLAINED OF A PAINFUL BREAST AND THE PATIENT CHOSE TO HAVE THE BIOZORB DEVICE REMOVED RATHER THAN WAIT FOR REABSORPTION. AT THE TIME OF REMOVAL, THE DEVICE WAS 9 MONTHS AFTER IMPLANTATION. THE DEVICE WAS REMOVED ON (B)(6) 2016, WITH "NOTHING CONCERNING ON THE PATHOLOGY REPORT."

  Patient problems: Breast Discomfort/Pain

  MAUDE report 21157840 ↗
• InjuryJan 13, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LUMPECTOMY AND BIOZORB PLACEMENT ON (B)(6) 2015. PATHOLOGY DETERMINED THE MARGINS WERE POSITIVE AND A RE-EXCISION WAS DONE ON (B)(6) 2015. DURING THE RE-EXCISION THE PHYSICIAN REMOVED THE BIOZORB DEVICE SO THE TISSUE COULD BE RE-EXCISED AND NOTED THAT THE MARKER WAS BROKEN AT THE MIDPOINT OF THE COIL. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REPORTED. THE DEVICE WAS RETURNED FOR INVESTIGATION AND A CONCLUSIVE ROOT CAUSE FOR THE DEFICIENCY COULD NOT BE FOUND. THE BIOZORB IS EXPECTED TO LOSE INTEGRITY AS PART OF THE NORMAL DEGRADATION PROCESS. HOWEVER, BECAUSE THE DEVICE IS SUTURED IN PLACED THE CLIPS ARE STILL HELD AT THE PERIPHERY OF THE CAVITY IN A 3-DIMENSIONAL ARRAY EVEN IF SPACER FRACTURES AS A RESULT OF THE DEGRADATION/RESORPTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137992 ↗
• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 66-YEAR-OLD FEMALE PATIENT HAD A SURGERY FOR BRACKETED LUMPECTOMY WITH NEEDLE LOCALIZED SATELLITE LESION/METASTASIC LYMPH NODE, AXILLARY DISSECTION AND BIOZORB PLACEMENT IN (B)(6) 2023 . IN 2023 PATIENT WAS NOTED TO HAVE A HEMATOMA/SEROMA WITH SIGNIFICANT ECCHYMOSIS. IN 2023 THE HEMATOMA/SEROMA WAS DRAINED AND CULTURE COLLECTED. ADDITIONALLY IN 2023 THE HEMATOMA/SEROMA WAS AGAIN DRAINED AND FIRMNESS NOTED AND SLIGHTLY WARM. PATIENT WAS PLACED ON ANTIBIOTICS AND IN AGAIN DRAINED. IN 2023 AN ABSCESS CAVITY WAS OPENED AND DEBRIDED WITH A SIGNIFICANT AMOUNT OF NECROTIC AND PURULENT MATERIAL AND THE BIOZORB MARKER REMOVED. ANOTHER CULTURE WAS COLLECTED. THE PATIENT WAS AGAIN PLACED ON ANTIBIOTICS AND LATER TREATED FOR WOUND CARE UNTIL THE ULCER CLOSED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Ecchymosis; Hematoma; Necrosis; Post Operative Wound Infection; Seroma

  MAUDE report 20069360 ↗
• InjuryDec 5, 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 MARKER IMPLANTATION ON NOVEMBER 2017, THE PATIENT REPORTED THAT SHE SUFFERS FROM A HARD, PAINFUL LUMP NEAR THE IMPLANTATION AREA AND IS IN CONSTANT PAIN AROUND THE SITE AND IT IS WORSENED UPON CONTACT MAKING IT DIFFICULT TO SLEEP OR LAY ON HER SIDE. NO OTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 18267108 ↗