BioZorb MarkerRecalls & reported problems across all models

We found 6 models of BioZorb Marker by Focal Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 50 adverse event reports in the FDA's MAUDE database, received between Jan 18, 2022 and May 11, 2026 — classified as 50 injuries.

The most frequently reported specific device problem is “Migration” (3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported BioZorb Marker problems

BioZorb Marker models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BioZorb Marker F0203

  Marker, Radiographic, Implantable
  19 reports
• BioZorb Marker F0304

  Marker, Radiographic, Implantable
  11 reports
• BioZorb Marker F0202

  Marker, Radiographic, Implantable
  9 reports
• BioZorb Marker F0303

  Marker, Radiographic, Implantable
  8 reports
• BioZorb Marker F0405

  Marker, Radiographic, Implantable
  2 reports
• BioZorb Marker F0404

  Marker, Radiographic, Implantable
  1 report

Recent BioZorb Marker adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMay 11, 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 SUBMITTED TO A SURGICAL INTERVENTION OF LEFT BREAST PARTIAL MASTECTOMY WITH BIOZORB IMPLANTATION ON (B)(6) 2017. MAMMOGRAM FROM (B)(6) 2018 SHOWED SEROMA AND HEMATOMA ON LUMPECTOMY SITE. ON (B)(6) 2018 THE PATIENT PRESENTED WITH INCREASE PAIN IN LEFT BREAST AND AN ULTRASOUND GUIDED ASPIRATION OF LEFT BREAST ABSCESS WAS PERFORMED. THE ABSCESS RECURRED AGAIN IN (B)(6) 2019. ON (B)(6) 2019 THE PATIENT PRESENTED WITH A LEFT BREAST CHRONIC ABSCESS TREATED WITH MULTIPLE COURSES OF ANTIBIOTICS AND ASPIRATION BUT THE PATIENT WAS SUBMITTED TO ABSCESS DRAINAGE AND SURGICAL CLEANING OF THE ENTIRE INFLAMED MASS SO THE BIOZORB WAS EXPLANTED AT THE SAME TIME. 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 S.

  Patient problems: Abscess; Bacterial Infection; Breast Discomfort/Pain; Breast Mass; Hematoma; Inflammation; Seroma

  MAUDE report 25141148 ↗
• 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 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT RECEIVED A BIOZORB DEVICE IMPLANT. IT IS REPORTED THAT THE PATIENT HAS EXPERIENCED INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE CHRONIC PAIN, SORENESS, AND SWELLING. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Breast Discomfort/Pain; Swelling/ Edema

  MAUDE report 22559816 ↗
• InjuryMay 27, 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. THE PATIENT REPORTS THAT SHE LATER SUFFERED FROM INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE A SOFT, SWOLLEN AND PAINFUL LUMP, PAIN, INFECTION, ITCHINESS, RASH AND SEROMA. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Bacterial Infection; Breast Discomfort/Pain; Itching Sensation; Rash; Seroma

  MAUDE report 22090883 ↗
• 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) 2021, LATER THE PATIENT REPORTED THAT SHE SUFFERED FROM PAIN, INFLAMMATION, DISCOMFORT, AND SENSITIVITY AT THE SITE OF IMPLANTATION. THE PATIENT REPORTED THAT SHE HAD THE DEVICE REMOVED ON (B)(6) 2023 AND FOLLOWING REMOVAL THE PATIENT HAD TO RECEIVED PHYSICAL THERAPY FOR LYMPHEDEMA. PATIENT REPORTED THAT THE SWELLING AND DISCOLORATION REMAIN BUT THAT THE PAIN HAS DECREASED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Inflammation; Seroma

  MAUDE report 21939059 ↗
• 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) 2015, LATER THE PATIENT REPORTED SHE EXPERIENCED A HARD LUMP, PAIN, SWELLING , INFLAMMATION AND DISCOMFORT. ADDITIONALLY THE PATIENT REPORTED THAT THE MARKER MIGRATED AND FAILED TO RESORB. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Swelling/ Edema

  MAUDE report 21938449 ↗
• 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 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 57-YEAR-OLD, NON-HISPANIC, WHITE FEMALE, WEIGHING 113 KG RECEIVED A BIOZORB DEVICE ON (B)(6) 2017. SHE REPORTS THAT SHE EXPERIENCES PAIN AND INCREASED SENSITIVITY SINCE IMPLANTATION. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 21909747 ↗
• 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) 2020, PATIENT REPORTED THAT SHE EXPERIENCED PAIN, SWELLING AND INFECTION AT THE SITE OF IMPLANTATION. PATIENT UNDERWENT EXCISIONAL BIOPSY ON HER LEFT BREAST ON (B)(6) 2023 AND THE BIOZORB DEVICE WAS REMOVED THEN. NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 21786093 ↗
• 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 ↗
• InjuryMar 19, 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) 2017. ON (B)(6) 2017 THE PATIENT RETURNED WITH SWOLLEN, WARM BREAST AND WAS PLACED ON ANTIBIOTICS. FLUID ASPIRATION CULTURED AS STAPHYLOCOCCUS AUREUS. ON (B)(6) 2017 THE BIOZORB WAS REMOVED AND THE PATIENT WAS DOING WELL WITH NO FURTHER COMPLICATIONS.

  Patient problems: Bacterial Infection; Breast Discomfort/Pain

  MAUDE report 21639980 ↗
• 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 ↗
• 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 BIOZORB IMPLANTED ON (B)(6) 2016. ABOUT ONE MONTH AFTER SURGERY THE PATIENT PRESENTED WITH EXCRUCIATING PAIN. A SEROMA WAS NOTED AND ASPIRATED WITH A NEGATIVE CULTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Seroma

  MAUDE report 21615628 ↗