BioZorb Marker F0304Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00851766006030), received between Sep 6, 2023 and Apr 30, 2025 — classified as 11 injuries.

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 11 most recent of 11 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) 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 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 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER ADDITIONAL REVIEW IT WAS DETERMINED THAT: THE PATIENT IS A 58-YEAR-OLD BLACK FEMALE, WEIGHING 194LBS, WITH A PAST MEDICAL HISTORY OF HYPERTENSION AND DIABETES MELLITUS. FAMILY HISTORY IS NEGATIVE FOR BREAST OR OVARIAN CANCERS. IN (B)(6) 2022 SCREENING MAMMOGRAM FOUND LEFT LOWER INNER QUADRANT MICROCALCIFICATIONS. DIAGNOSTIC MAMMOGRAM (B)(6) 2022 FOUND LEFT INNER QUADRANT BRANCHING PLEOMORPHIC CALCIFICATIONS, 3.5X2.4X1.7CM. ON (B)(6) 2022 LEFT BREAST STEREOTACTIC BIOPSY WAS PERFORMED, PATHOLOGY REVEALED MULTICENTRIC DCIS WITH MICROINVASION INTERMEDIATE GRADE WITH COMEDONECROSIS AND CALCIFICATIONS WITH EXTENT OF ABNORMAL CALCIFICATIONS MEASURED AT LEAST 8.5CM. ER-72%, PR3%, HER2/NEU-. BILATERAL BREAST MRI ON (B)(6)2022 FOUND 8.5CM OF CLUMPED ENHANCEMENT ON INFERIOR MEDIAL ASPECT OF LEFT BREAST. NO SUSPICIOUS NODES AND NO EVIDENCE OF MALIGNANCY ON THE RIGHT. ON (B)(6)2022 THE PATIENT UNDERWENT LEFT AXILLARY SENTINEL NODE BIOPSY, LEFT PARTIAL MASTECTOMY WITH NEEDLE LOCALIZATION, ADJACENT TISSUE TRANSFER AND PLACEMENT OF 3X4CM BIOZORB MARKER IN INFERIOR POSTERIOR AREA SECURED IN PLACE W INTERRUPTED 3-0 PDS WITH ADDITIONAL TISSUE TRANSFER AND PLACEMENT OF A 2X2CM BIOZORB LOW PROFIL

  Patient problems: Bacterial Infection; Breast Discomfort/Pain; Erythema

  MAUDE report 21553382 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 68-YEAR-OLD PATIENT RECEIVED A BIOZORB (F0304) PLACEMENT ON (B)(6) 2019 DURING A LUMPECTOMY DUE TO RESULTS FROM A BIOPSY ON (B)(6) 2019 THAT REVEALED IDC, INVASIVE LOBULAR/MULTIFOCAL. PATIENT RECEIVED CEFAZOLIN PRE-SURGERY. PATIENT RECEIVED RADIATION THERAPY FROM ON (B)(6) 2019 UP UNTIL ON (B)(6) 2019. LATER IT WAS REPORTED THAT THE PATIENT STARTED EXPERIENCING PAIN IN HER BREAST AND HER AREA BECAME RED DURING RADIATION TREATMENTS. BIOZORB WAS REMOVED IN OFFICE AS IT WAS ERODING THROUGH THE SKIN ON (B)(6) 2019.

  Patient problems: Breast Discomfort/Pain; Erosion; Erythema

  MAUDE report 20758681 ↗
• 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 86 KG FEMALE PATIENT UNDERWENT A PARTIAL MASTECTOMY WITH TWO BIOZORB PLACEMENTS ON (B)(6) 2019. PATIENT REPORTED THAT 1 DAY AFTER THE SURGERY 1 BREAST WAS WARM AND RED. LATER ON AN UNKNOWN DATE PATIENT HAD IRRIGATION AND DEBRIDEMENT AND STARTED ON ANTIBIOTICS. PATIENT COMPLAINED OF BREAST SWELLING IN DRAINAGE LEADING TO REMOVAL OF THE BIOZORB ON (B)(6) 2019. PATIENT HAD A HISTORY OF HYPERTENSION. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Erythema; Swelling/ Edema; Wound Infection

  MAUDE report 20118254 ↗
• InjuryNov 28, 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 INFECTIONS NEAR THE SITE OF THE BIOZORB DEVICES ON OR AROUND (B)(6), 2023, AND (B)(6), 2023. ALSO REPORTED THAT ONE OF THE BIOZORB DEVICES MIGRATED AND NOW PROTRUDES OUT OF THE LEFT BREAST CAUSING CONSTANT PAIN, THAT IS SEVERELY WORSENED UPON CONTACT. THE PATIENT REPORTED THAT AS A RESULT OF THE PAIN AND POTENTIAL FOR INFECTION, HAD TO LIMIT HER MOBILITY SO AS TO NOT IRRITATE THE AREA. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Abscess; Bacterial Infection; Breast Discomfort/Pain; Erythema; Unspecified Infection

  MAUDE report 18222268 ↗
• InjuryNov 9, 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 ON (B)(6) 2021. THE PATIENT REPORTED THAT SHE IS SUFFERING FROM PAIN AND DISCOMFORT AT THE IMPLANTATION SITE AND THAT IT IS MAKING IT DIFFICULT FOR HER TO WEAR A SEATBELT AND THAT IS PAINFUL TO SLEEP ON HER SIDE AND IT¿S AFFECTING HER DAILY LIFE. NO OTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 18106444 ↗
• 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) 2018 IN WHICH A BIOZORB WAS IMPLANTED. THE PATIENT HAD A PRIOR DIAGNOSIS OF RIGHT BREAST INVASIVE LOBULAR CARCINOMA. PATIENT REPORTED THAT THE DEVICE ¨STUCK OUT¨OF HER CHEST AND CAUSED CONSTANT PAIN AND DISCOMFORT. PATIENT REPORTED THAT SHE HAD DIFFICULTY SLEEPING DUE TO PAIN AND COULD NOT HUG OTHER PEOPLE. PATIENT REPORTED THAT A PHYSICIAN SUGGESTED THAT THE DEVICE WOULD DISSOLVE IN TWO YEARS, THE PATIENT AWAITED ADDITIONALLY THREE YEARS FOR THE DEVICE TO REABSORB AND EVENTUALLY HAD A SURGERY TO REMOVE THE BIOZORB IN (B)(6)2022. PATIENT REPORTED RELIEF AFTER THE SURGERY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Bacterial Infection; Breast Discomfort/Pain; Deformity/ Disfigurement; Depression; Erythema; Loss of Range of Motion; Swelling/ Edema; Weight Changes

  MAUDE report 17695258 ↗
• 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 RIGHT BREAST MASTECTOMY ON (B)(6) 2018 DURING WHICH A BIOZORB WAS PROPERLY IMPLANTED. PATIENT HAD A PRIOR DIAGNOSIS OF INVASIVE DUCTAL CARCINOMA ON HE RIGHT BREAST. THE PATIENT WAS INSTRUCTED BY HER PHYSICIAN THAT THE BIOZORB SHOULD DISSOLVE WITHIN A YEAR, BUT THE PATIENT REPORTS THAT AFTER 4 YEARS IT IS STILL PALPABLE AND CAUSES HER PAIN. THE PATIENT IS REPORTING ITCHINESS AND PAIN SURROUNDING THE SITE OF IMPLANTATION AND REFERS THAT SHE CAN FEEL IT WHEN SHE RAISES HER ARM. IT WAS REPORTED THAT THE DEVICE OBSCURES VISUALIZATION OF THE LUMPECTOMY SITE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Contact Dermatitis; Itching Sensation

  MAUDE report 17691982 ↗
• 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) 2017 A BIOZORB WAS IMPLANTED IN THE PATIENT AND THE PATIENT REPORTED SUFFERING A HARD, PAINFUL LUMP AND IRRITATION AT THE SITE OF THE BIOZORB DEVICE. ALSO REPORTED THAT THE DEVICE FAILED TO DISSOLVE FOR ALMOST FIVE (5) YEARS. THE PATIENT REPORTED HAVING THE BIOZORB REMOVED ON OR AROUND (B)(6) 2022. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Bacterial Infection; Breast Discomfort/Pain; Breast Mass; Erythema

  MAUDE report 17690030 ↗