BioZorb F0231Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 15420045514034), received between Sep 5, 2023 and May 12, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

1 other recall cover devices cleared under the same FDA submission (K152070); they may or may not involve this specific model.

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  HOLOGIC HAS RECEIVED CORRESPONDENCE ARISING FROM LITIGATION. THE LITIGATION ALLEGES THAT A 48-YEAR-OLD PATIENT WAS IMPLANTED ON (B)(6), 2022 WITH A BIOZORB MARKER FOLLOWING A SURGICAL PROCEDURE FOR A LEFT BREAST LUMPECTOMY. ON (B)(6) 2024 THE PATIENT PRESENTED WITH COMPLAINTS OF BIOZORB MARKER FAILING TO DISSOLVE AND IT BOTHERED THE PATIENT. PATIENT REQUESTED TO HAVE THE BIOZORB MARKER REMOVED. IT WAS REMOVED ON THE SAME DATE WITH THE MENTION THAT AN INFECTION WAS NOT PRESENT AT THE DATE OF REMOVAL. 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

  MAUDE report 25153628 ↗
• InjuryAug 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 IMPLANT ON (B)(6) 2023. IT WAS FURTHER REPORTED THAT THE PATIENT HAS EXPERIENCED INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE PAIN, SWELLING, RASHES, AND SCAR TISSUE. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Rash; Scar Tissue; Swelling/ Edema

  MAUDE report 22894249 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 44-YEAR-OLD, NON-HISPANIC WHITE FEMALE PATIENT, WEIGHING 64 KILOGRAMS RECEIVED A BIOZORB IMPLANT AND HAS EXPERIENCED INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDES PAIN AND A LARGE LUMP. IT IS REPORTED THAT THE PATIENT HAD A REPEAT MRI. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE. PATIENT REPORTED MEDICATIONS INCLUDE: ASPIRIN, CLONIDINE PATCH, LOSARTAN, METOPROLOL, SINGULAIR AND XANAX.

  Patient problems: Breast Discomfort/Pain; Breast Mass

  MAUDE report 22628293 ↗
• InjuryJul 1, 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) 2022. THE PATIENT REPORTS INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE PAIN, INFECTION, SEROMA, SCAR TISSUE, DISFIGUREMENT, FAILURE TO REABSORB AND SLEEP DYSFUNCTION. THE PATIENT ALSO REPORTS THAT MEDICATION AND ADDITIONAL IMAGING HAS BEEN REQUIRED. PATIENT REPORTED MEDICATIONS: AMITRIPTYLINE, DICLOFENAC, GLUCOSAMINE, HYDROXYZINE, JARDIANCE, LETROZOLE, LOSARTAN, LOW DOSE ASPIRIN, METFORMIN, METHOCARBAMOL, OMEPRAZOLE, POTASSIUM, SIMVASTATIN, SOLIFENACIN, VITAMIN C. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Bacterial Infection; Breast Discomfort/Pain; Deformity/ Disfigurement; Scar Tissue; Seroma; Sleep Dysfunction

  MAUDE report 22370991 ↗
• 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) 2024, A PATIENT RECEIVED A BIOZORB DEVICE. IT IS REPORTED THAT THE PATIENT HAS EXPERIENCE INJURIES AT AND AROUND THE SITE OF IMPLANTATION, WHICH INCLUDE SEVERE PAIN, HARD PAINFUL LUMPS, SENSITIVITY, PROTRUSION, SEROMA, AND DEFORMITY. ADDITIONALLY, IT IS REPORTED THAT THE PATIENT HAD THE DEVICE REMOVED ON (B)(6) 2025. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Breast Discomfort/Pain; Breast Mass; Cellulitis; Deformity/ Disfigurement; Seroma

  MAUDE report 22169312 ↗
• 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 THE BIOZORB DEVICE. IT IS REPORTED THAT THE PATIENT EXPERIENCED CHRONIC PAIN AND DISCOMFORT, AND A FIRM MASS AT THE SITE OF THE BIOZORB. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT BREAST LUMPECTOMY ON (B)(6) 2025, AT WHICH POINT THE BIOZORB DEVICE WAS REMOVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Breast Mass

  MAUDE report 22100094 ↗
• 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) 2022, FOLLOWING IMPLANTATION THE PATIENT REPORTED EXPERIENCED PAIN, WEAKNESS, SENSITIVITY, OPEN WOUND, PROTRUSION OF THE DEVICE, MIGRATION, FAILURE TO RESORB AND DUE TO THE DEVICE PROTRUDING THROUGH THE SKIN AND ONGOING PAIN THE PATIENT UNDERWENT ADDITIONAL SURGERY ON (B)(6) 2023 TO REMOVE THE DEVICE. FOLLOWING DEVICE REMOVAL PATIENT REQUIRED WOUND CARE FOR MULTIPLE WEEKS. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Erosion; Impaired Healing; Post Operative Wound Infection

  MAUDE report 21938309 ↗
• 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) 2019, PATIENT REPORTED THAT SHE EXPERIENCED PAIN AND SWELLING AT THE SITE OF IMPLANTATION. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Swelling/ Edema

  MAUDE report 21786202 ↗
• 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) 2018, DURING A LUMPECTOMY. THE PATIENT, ON THE COURSE FROM (B)(6) 2018, TO (B)(6) 2018, REQUIRED MULTIPLE VISITS TO THE SURGEON'S OFFICE DUE TO SEROMA AND INFECTION WHICH REQUIRED DRAINAGE, ASPIRATION CULTURES AND MEDICATION. THE PATIENT RECEIVED DIFFERENT ANTIBIOTICS AND ONE OF THE CULTURES WAS POSITIVE FOR MRSA. ON (B)(6) 2018, THE WOUND WAS REPORTED AS HEALING. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Bacterial Infection; Impaired Healing; Seroma

  MAUDE report 21675948 ↗
• InjuryMar 24, 2025Fracture; Migration or Expulsion of Device; Migration; Fracture; Migration or Expulsion of Device; Migration

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB IMPLANTATION ON (B)(6) 2018, PATIENT RECEIVED RADIATION TREATMENT FROM (B)(6) 2018. THE PATIENT DEVELOPED A WOUND BLISTER FOLLOWING RADIATION AND THE DEVICE WAS VISIBLE WITHIN THE WOUND. THE WOUND WAS REPORTED TO HAVE OPENED UP ON (B)(6) 2018, AND IT WAS REPORTED THAT A PIECE OF METAL AND PLASTIC WAS PROTRUDING. ON (B)(6) 2018, THE PATIENT WAS SEEN BY A PHYSICIAN WHO REMOVED THE PART THAT WAS VISIBLE AFTER IT WAS FRACTURED AND ADMINISTERED WITH LOCAL ANESTHESIA AND CLEAN THE AREA WITH BETADINE TO THE PATIENT. ON (B)(6) 2018 THE PATIENT WAS TAKEN TO THE OPERATING ROOM TO EXCISE THE BIOZORB.

  Patient problems: Breast Discomfort/Pain; Wound Dehiscence

  MAUDE report 21675100 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A PHYSICIAN THAT A PATIENT WAS IMPLANTED A BIOZORB DEVICE ON (B)(6) 2018, DUE TO POSITIVE MARGINS THE PATIENT RECEIVED A RE-EXCISION ON (B)(6) 2018 AND WAS TREATED WITH RADIATION + BOOST FROM (B)(6) 2018 UP UNTIL (B)(6) 2018. THE PHYSICIAN REPORTED THAT THE DEVICE WAS REMOVED ON (B)(6) 2018. THE PHYSICIAN WAS CONTACTED BY EMAIL AND RESPONDED THAT HE BELIEVED THAT HE WAS USING A SIZE TOO LARGE AND HAD CORRECTED THE PROCEDURES BY USING A SMALLER BIOZORB SIZE.

  Patient problems: Insufficient Information

  MAUDE report 21674840 ↗
• InjuryOct 11, 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 PATIENT RECEIVED A BIOZORB DEVICE DURING A SURGERY TO REMOVE 3 LYMPH NODES IN HER LEFT AXILLA FOR BREAST CANCER. PATIENT REPORTED THAT SHE WAS IN CONSTANT PAIN SINCE (B)(6)2024 DISCOLORATION AND LATER SKIN CHANGES APPEARED ON HER LEFT BREAST WHICH REQUIRED MULTIPLE LABS, RADIOLOGY AND BIOPSY TESTS. ON (B)(6) 2024 SHE UNDERWENT SURGERY TO HAVE THE BIOZORB REMOVED DUE TO PAIN AND NOT BEING RESORBED. PATIENT REPORTED THAT SHE EXPERIENCED PAIN SINCE (B)(6) 2023 UP UNTIL REMOVAL IN (B)(6) 2024. PAIN MADE IT DIFFICULT TO SLEEP ON HER SIDE, AND MOVEMENT OF HER ARM WAS DIFFICULT. IT WAS REPORTED THAT DISCOLORATION OF HER BREAST WAS OBSERVED AND ORANGE-PEEL SKIN LIKE AND ENLARGEMENT OF AFFECTED LEFT BREAST, LUMPINESS OR FLUID BUILDUP ON THE LEFT BREAST. PATIENT REPORTED THAT THE LEFT BREAST IS NOTABLE LARGER. SHE RECEIVED CT SCAN, PET SCAN, PUNCH BIOPSY, MAMMOGRAM, BREAST MRI, ULTRASOUND AND SURGERY TO REMOVE THE BIOZORB. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Skin Discoloration; Skin Disorders

  MAUDE report 20433388 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BIOZORB WAS IMPLANTED ON AN UNKNOWN DATE AND IT WAS DISCOVERED DURING ADDITIONAL BREAST SURGERY THAT IT HAD NOT ABSORBED AND CONCERNS RELATED TO IMPACTING THE LYMPHATIC SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19956760 ↗
• InjuryMar 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A BIOZORB PROCEDURE WAS PERFORMED AND THE PATIENT REPORTED SUFFERING FROM PAIN, ITCHING, TENDERNESS, AND A BURNING SENSATION AT AND AROUND THE SITE OF THE BIOZORB DEVICE. ALSO, THE PATIENT REPORTED SUFFERING FROM ADVERSE SKIN REACTIONS AND SUFFERING FROM INFECTION. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Burning Sensation; Erythema; Itching Sensation; Unspecified Infection

  MAUDE report 18815075 ↗
• 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) 2016 DURING WHICH A BIOZORB WAS IMPLANTED. PATIENT HAD A PRIOR DIAGNOSIS OF LEFT BREAST INVASIVE DUCTAL CARCINOMA. PATIENT REPORTED THAT SHE DEVELOPED A SIGNIFICANT AMOUNT OF SCARING ON HER CHEST WALL AT THE IMPLANTATION SITE. PATIENT REPORTED THAT SHE SUFFERED FROM DEFORMITY, SCARRING, AND HARD PAINFUL LUMPS THAT LIMITED HER MOBILITY. PATIENT RECEIVED A SURGERY IN WHICH THE BIOZORB WAS REPORTED TO HAVE BEEN SEPARATED FROM HER CHEST WALL. PATIENT REPORTED THAT SHE IS GOING TO PHYSICAL THERAPY TO ADDRESS THE PAIN, MOBILITY AND MUSCLE LOSS RELATED TO THE SURGERY. PATIENT REPORTS THAT SHE IS STILL IN CONSTANT PAIN. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Bacterial Infection; Breast Discomfort/Pain; Deformity/ Disfigurement; Inflammation; Scar Tissue

  MAUDE report 17695484 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A BIOZORB IMPLANTED ON (B)(6) 2021. PATIENT HAD A PRIOR DIAGNOSIS OF BREAST CANCER. PATIENT REPORTS THAT SHE HAS EXPERIENCED INFECTION, SWELLING, SEROMAS AND ADDITIONAL PROCEDURES TO DRAIN FLUID FROM HER BREAST. PATIENT REPORTS THAT SHE CONTINUES TO SUFFER A HARD PAINFUL LUMP, DEFORMITY, DISCOLORATION OF HER SKIN, SWELLING, SENSITIVITY OF HER BREAST, PROTRUSION OF THE DEVICE, DIFFICULTY SLEEPING, LIMITED ACTIVITIES DUE TO PAIN, PTSD AND DEPRESSION DUE TO THIS COMPLICATIONS. PATIENT REPORTS THAT THE DEVICE HAS NOT DISSOLVED IN THE YEAR AND A HALF SINCE IT WAS IMPLANTED. PATIENT IS PENDING ADDITIONAL TESTING TO EVALUATE RECURRENCE OF BREAST CANCER.

  Patient problems: Bacterial Infection; Breast Discomfort/Pain; Hematoma; Seroma; Sleep Dysfunction

  MAUDE report 17695403 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 A BIOZORB WAS IMPLANTED IN THE PATIENT AND THE PATIENT REPORTED SUFFERING A HARD, PAINFUL LUMP, SIGNIFICANT PAIN, FAT NECROSIS, DEFORMITY AND SCARRING OF THE SKIN, SENSITIVITY, ITCHING, SWELLING AND REDDENING OF THE SKIN, SPIDER VEINS ON HER BREAST, AND THAT THE MARKER FAILED TO DISSOLVE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Abnormal scarring; Breast Discomfort/Pain; Burning Sensation; Deformity/ Disfigurement; Erythema; Itching Sensation; Necrosis; Nodule; Rash; Swelling/ Edema

  MAUDE report 17690131 ↗
• 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) 2022, A BIOZORB WAS IMPLANTED IN THE PATIENT, AND THE PATIENT REPORTED SUFFERING FROM HARD, PAINFUL LUMPS AND EDEMA NEAR THE AREA WHERE THE BIOZORB WAS IMPLANTED, EXPERIENCED SENSITIVITY, ITCHING, SWELLING, AND REDDENING OF THE SKIN ON HER BREAST. ALSO REPORTED THAT THE AREA REMAINS SORE TO THE TOUCH AND SHE HAS TROUBLE SLEEPING BECAUSE OF THE PAIN CAUSED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Erythema; Itching Sensation; Sleep Dysfunction; Swelling/ Edema

  MAUDE report 17686216 ↗
• 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 TO THE PATIENT AND THE PATIENT REPORTED SUFFERING A HARD, PAINFUL LUMP THAT HAD DEVELOPED NEAR THE SITE OF THE BIOZORB DEVICE, WHICH HAS NOT DISSOLVED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Erythema

  MAUDE report 17686139 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152070. One submission often covers many models, so check the product and lot details in each record.

• Z-1858-2022 · Aug 9, 2022 · Open, Classified
  The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylac