BioZorb Marker F0203Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00851766006016), received between Jan 18, 2022 and May 11, 2026 — classified as 19 injuries.

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

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 19 most recent of 19 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗
• 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. APPROXIMATELY 8 WEEKS AFTER IMPLANTATION, THE PATIENT PRESENTED WITH SWELLING AND REDNESS. A SEROMA WAS ASPIRATED AND I&D PUS, NO GROWTH. THE PATIENT WAS STARTED ON ANTIBIOTICS AND RECOMMENDATION WAS MADE TO REMOVE BIOZORB. PATIENT REFUSED ALL TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Bacterial Infection; Erythema; Pain; Seroma; Swelling/ Edema

  MAUDE report 21615627 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER ADDITIONAL MEDICAL REVIEW IT WAS REPORTED THAT 67 YEARS OLD, WEIGHT 121 LBS., BMI 25, RECEIVED 2 BIOZORB MARKERS (F0203) ON (B)(6) 2020 DURING A LEFT BREAST SEGMENTECTOMY WHICH WAS SECURED TO THE PECTORALIS FASCIA CIRCUMFERENTIALLY (DEEP THERMAL TISSUE WAS 3-0 VICRYL AND THE SKIN WAS CLOSED WITH 4-0 MONOCRYL SUBCUTICULAR SUTURE. EXPAREL WAS INJECTED FOR POST OP PAIN CONTROL. PATIENT REFUSED SENTINEL NODE ASSESSMENT, RADIATION OR ANY ADDITIONAL THERAPY AT THIS TIME. PATHOLOGY REVEALED A SINGLE FOCUS OF GRADE 3 CCIS WITH COMEDONECROSIS WITHOUT INVASIVE CANCER AND WITH CLEAR MARGINS. PATIENT REPORTED PAIN AND OVERALL DISCONTENT WITH THE BIOZORB DEVICES STARTING AT IMMEDIATE POST-OPERATIVE VISITS. SHE EXPRESSED A DESIRE FOR REMOVAL. PHYSICIANS AT THE TIME RECOMMENDED WATCHFUL WAITING AS BIOZORB RESORBED. POST OPERATIVE VISIT ON (B)(6) 2020, NOTES THAT THE PATIENT WAS DOING WELL BUT WAS EXPERIENCING PAIN RELATED TO IMPLANT AND WOULD LIKE THE IMPLANT REMOVED. PHYSICAL EXAM REVEALED NO TENDERNESS, NODULARITY OR MASSES, NO SOI, NO SEROMA OR HEMATOMA, BIOZORB PALPABLE AS EXPECTED AND INCISION C/D/I. ON (B)(6) 2020, PATIENT REPORTED THAT SHE HATED THE DEVICE AND DID NOT UNDERSTAND WHY

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

  MAUDE report 20593281 ↗
• InjurySep 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 49 YEARS OLD 97 KG FEMALE PATIENT UNDERWENT A PARTIAL MASTECTOMY, LYMPH NODE EXCISION AND BIOZORB PLACEMENT ON (B)(6) 2019. LATER PATIENT REPORTED HAVING A SUPERFICIAL WOUND IDENTIFIED AS BIOZORB EXTRUDING FROM THE SKIN. PATIENT RETURNED TO THE OPERATING ROOM AND SURGEON REPORTED THAT THE BIOZORB HAD BEGUN TO BREAK DOWN IN TWO PIECES, BOTH PIECES REMOVED AND DISCARDED ON (B)(6) 2019. PATIENT REPORTED PREVIOUS CONDITION: DIABETES. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Erosion

  MAUDE report 20118208 ↗
• InjurySep 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 58 YEARS OLD, 64 KG FEMALE PATIENT UNDERWENT A RIGHT PARTIAL MASTECTOMY WITH NODE BIOPSY AND BIOZORB PLACEMENT ON (B)(6) 2017. POSTERIORLY IT WAS REPORTED THAT THE PATIENT FELT A PALPABLE HARD LUMP NEAR THE BIOZORB SITE. PATIENT HAD TO UNDERGO EXCISION ON (B)(6) 2020, FOR ADDITIONAL LESIONS IN THE RIGHT BREAST AND THE SURGEON NOTED THAT SEVERAL CLIPS WERE FOUND IN THE CAVITY FROM THE BIOZORB THAT HAD DISSOLVED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain

  MAUDE report 20118009 ↗
• InjurySep 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 64 KG 49 YEARS OLD FEMALE PATIENT UNDERWENT A PARTIAL MASTECTOMY, EXCISION OF LYMPH NODE, AND PLACEMENT OF BIOZORB ON (B)(6) 2018, PATIENT HAD TO UNDERGO A RE-EXCISION AND REPOSITIONING OF INITIAL BIOZORB AND PLACEMENT OF A SECOND BIOZORB ON (B)(6) 2018. LATER PATIENT REPORTED SWELLING, FIRMNESS AND NIPPLE INVERSION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Discomfort/Pain; Swelling/ Edema

  MAUDE report 20117892 ↗
• InjurySep 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 64 KG 49 YEARS OLD FEMALE PATIENT UNDERWENT A PARTIAL MASTECTOMY, EXCISION OF LYMPH NODE, AND PLACEMENT OF BIOZORB ON (B)(6) 2018, PATIENT HAD TO UNDERGO A RE-EXCISION AND REPOSITIONING OF INITIAL BIOZORB AND PLACEMENT OF A SECOND BIOZORB ON (B)(6) 2018. LATER PATIENT REPORTED SWELLING, FIRMNESS AND NIPPLE INVERSION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Breast Discomfort/Pain; Swelling/ Edema

  MAUDE report 20117828 ↗
• InjuryNov 30, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 A BIOZORB WAS IMPLANTED IN A PATIENT. THE PATIENT REPORTED SUFFERING FROM A HARD, PAINFUL LUMP AT THE SITE OF THE BIOZORB DEVICE THAT AFFECTED HER DAILY LIFE, INCLUDING MAKING IT DIFFICULT TO LIE DOWN. THE PATIENT REPORTED THAT ¨THE BIOZORB MIGRATED¨, CAUSING FURTHER PAIN AND LEADING TO ADDITIONAL SURGERY TO REMOVE THE BIOZORB DEVICE ON OR AROUND JULY 10, 2020, THIS INFORMATION COULD NOT BE CONFIRMED. NO ADDITIONAL INFORMATION.

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

  MAUDE report 18240016 ↗
• InjuryNov 29, 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, THE PATIENT REPORTED SUFFERING FROM A HARD, PAINFUL LUMP AND REDDENING OF THE SKIN NEAR THE AREA WHERE THE BIOZORB DEVICE WAS IMPLANTED. THE PATIENT ALSO REPORTED THAT THE PAIN WORSENED UPON TOUCH AND ALSO REPORTED FREQUENTLY SUFFERING FROM SHOOTING PAINS AROUND HER RIGHT ARMPIT AND BACK THAT ORIGINATE FROM THE SITE OF THE BIOZORB DEVICE. THE PATIENT REPORTED THAT THESE PAINS AFFECT DAILY LIFE, MAKE IT DIFFICULT TO SLEEP OR LAY ON THE RIGHT SIDE, AND MAKE IT DIFFICULT TO LIFT THE ARM WHILE DRIVING. NO ADDITIONAL INFORMATION AVAILABLE.

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

  MAUDE report 18228687 ↗
• 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) 2020 DURING WHICH A BIOZORB WAS IMPLANTED. PATIENT HAD A PRIOR DIAGNOSIS OF INTRADUCTAL CARCINOMA IN SITU IN HER RIGHT BREAST. PATIENT REPORTED THAT SHE SUFFERED FROM A HARD, PAINFUL LUMP OF NECROTIC TISSUE NEAR HER IMPLANTATION SITE AND DISFIGUREMENT OF HER BREAST. PATIENT REPORTED THAT SHE HAS TROUBLE SLEEPING DUE TO THE PAIN. ADDITIONALLY PATIENT REPORTED THAT SHE HAS HAD ADDITIONAL APPOINTMENTS DUE TO A MASS IN HER BREAST. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement; Necrosis; Scar Tissue; Sleep Dysfunction

  MAUDE report 17695365 ↗
• 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) 2020, A PATIENT UNDERWENT A SEGMENTECTOMY DURING WHICH A BIOZORB WAS IMPLANTED. PATIENT HAD A PRIOR DIAGNOSIS OF DUCTAL CARCINOMA IN SITU. PATIENT REPORTED THAT SHE HAD A HARD, SWOLLEN LUMP AT THE SITE OF IMPLANTATION AND SUFFERED EXTREME PAIN FOR TWO YEARS. PATIENT REPORTED THAT SHE HAD DIFFICULTY SLEEPING AND DOING DAILY ACTIVITIES BECAUSE OF THE PAIN IN HER IMPLANTATION SITE. LATER THE PATIENT WAS REPORTED TO HAVE DEVELOPED CANCER IN THE SAME LOCATION AS THE BIOZORB AND UNDERWENT A DOUBLE MASTECTOMY IN (B)(6) 2022 AS TREATMENT FOR THE CANCER. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Sleep Dysfunction

  MAUDE report 17692209 ↗
• 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 PATIENT RECEIVED A LUMPECTOMY AND A BIOZORB PLACEMENT. THE PATIENT HAD A PREVIOUS DIAGNOSIS OF CANCER IN HER LEFT BREAST. THE PATIENT REPORTED THAT SHE EXPERIENCED PAIN, PULLING AND TUGGING IN THE IMPLANTATION SITE OF THE BIOZORB WORSENED BY ARM MOVEMENT. PATIENT WAS UNABLE TO SLEEP AND HAD TO TAKE MEDICATION TO HELP HER SLEEP. ON (B)(6) 2022 THE PATIENT UNDERWENT A LEFT BREAST EXCISIONAL BIOPSY TO REMOVE A MASS THAT HAD GROWN IN THE SURGICAL SITE AND TO REMOVE THE BIOZORB DEVICE. THE PHYSICIAN REPORTED OBSERVED A CLIP IN THE MASS AND AN UNUSUAL WHITE FLUID. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Anxiety; Breast Discomfort/Pain; Deformity/ Disfigurement; Scar Tissue; Sleep Dysfunction

  MAUDE report 17691404 ↗
• 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) 2020 A BIOZORB WAS IMPLANTED IN THE PATIENT, AND THE PATIENT REPORTED SUFFERING FROM A HARD, PAINFUL, PALPABLE LUMP WHERE THE BIOZORB WAS IMPLANTED. IT WAS REPORTED THAT THE BIOZORB DEVICE HAS NOT BEEN ABSORBED AND HAS CAUSED SWELLING OF HER BREAST. THE PATIENT REPORTED SUFFERING FROM CONSTANT PAIN AND TENDERNESS IN HER BREAST WHERE THE BIOZORB DEVICE WAS IMPLANTED. THIS HAS IMPACTED HER DAILY LIFE INCLUDING SLEEP, WEARING CLOTHING, AND INTIMACY. NO ADDITIONAL INFORMATION AVAILABLE.

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

  MAUDE report 17691277 ↗
• 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 FROM A PALPABLE MASS, SENSITIVITY, ITCHING, SWELLING, REDNESS OF THE SKIN, AND PAIN AT THE SITE OF THE BIOZORB. THE PATIENT ALSO REPORTED HAVING THE BIOZORB REMOVED ON OR AROUND (B)(6) 2021. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Breast Mass; Erythema; Fluid Discharge; Itching Sensation; Swelling/ Edema

  MAUDE report 17689952 ↗
• InjuryJan 18, 2022Migration; Migration

  IT WAS REPORTED THAT A PATIENT RECEIVED A LUMPECTOMY WITH SENTINEL NODE DISSECTION FOR AN INVASIVE LOBULAR CARCINOMA ON (B)(6) 2020, THE PHYSICIAN PLACED A BIOZORB MARKER AND LATER THE PATIENT RECEIVED RADIATION FOR FOUR WEEKS. LATER THE PATIENT EXPERIENCED A LOT OF PAIN AND OBSERVED A BULGE BETWEEN THE LUMPECTOMY SCAR AND THE LYMPH NODE SCAR, FOR WHICH AN ULTRASOUND WAS PERFORMED AN A BIOZORB MARKER WAS OBSERVED, AND IT WAS NOTED THAT THE MARKER HAD MIGRATED FROM THE TUMOR BED. PATIENT EXPERIENCED GREAT PAIN AND LIMITED ABILITY TO USE HER LEFT ARM. THE BIOZORB MARKER WAS REMOVED ON (B)(6) 2021, AFTER 6 MONTHS OF RADIATION. IT WAS REPORTED ON (B)(6) 2021 THAT THE MARKER HAD MIGRATED TOWARDS THE AXILLA. CURRENT CONDITION OF THE PATIENT IS LIMITED MOBILITY ON HER LEFT SHOULDER, SWELLING AND PAIN IN HER ARM AND AXILLARY AREA AND SCAR TISSUE AND SEROMA AT THE SITE WHERE IT WAS REMOVED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain; Seroma; Swelling/ Edema

  MAUDE report 13285182 ↗