PERL Localization Device R2020Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00851766006092), received between Sep 6, 2023 and Mar 30, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Migration” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A BIOZORB IMPLANT ON (B)(6) 2021. IT IS REPORTED THAT THE PATIENT HAS EXPERIENCED FATIGUE AS WELL AS PAIN, SEROMA, PETECHIA, A HARD LUMP, NECROSIS AT THE SITE OF IMPLANTATION, SWELLING, NUMBNESS IN THE SHOULDER, LOSS OF RANGE OF MOTION AND LYMPHEDEMA. IT IS REPORTED THAT THE PATIENT IS SCHEDULED TO HAVE THE BIOZORB IMPLANT REMOVED ON (B)(6) 2026. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Breast Mass; Deformity/ Disfigurement; Loss of Range of Motion; Necrosis; Numbness; Rash; Seroma; Swelling/ Edema

  MAUDE report 24729453 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  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 AND DISCOMFORT, ITCHING, RASHES, A HARD MASS AND FAILURE TO REABSORB. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Breast Mass; Itching Sensation; Rash

  MAUDE report 22896584 ↗
• 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) 2020. IT IS REPORTED THAT SINCE THE TIME OF IMPLANTATION, THE PATIENT HAS SUFFERED INJURIES AT AND AROUND THE IMPLANTATION SITE WHICH INCLUDE SWELLING, SORENESS, SEVERE PAIN AND IRRITATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Seroma; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 21939328 ↗
• 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 ON (B)(6) 2021, AFTER THE IMPLANTATION THE PATIENT REPORTED EXPERIENCED PAIN, DISCOMFORT, DISCOLORATION, ITCHING, SWELLING, SENSITIVITY, FAILURE TO RESORB. THE PATIENT HAD THE DEVICE REMOVED ON (B)(6) 2025. NO OTHER INFORMATION AVAILABLE.

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

  MAUDE report 21938372 ↗
• InjuryApr 16, 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 REPORTED THAT FOLLOWING IMPLANTATION SHE EXPERIENCED IRRITATION, PAIN, HARD LUMPS, SENSITIVITY, RASHES, PROTRUSION, NECROSIS, DRAINAGE, AND DEFORMITY AT THE SITE OF IMPLANTATION. ADDITIONALLY, THE PATIENT REPORTED THAT SHE SUFFERED FROM A CHRONIC OPEN WOUND TO HER RIGHT BREAST. PATIENT REPORTED THAT THE BIOZORB FRACTURED AND FAILED TO RESORB. PATIENT HAD THE BIOZORB DEVICE REMOVED ON (B)(6) 2023. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Deformity/ Disfigurement; Erosion; Necrosis; Rash; Wound Dehiscence

  MAUDE report 21849016 ↗
• InjuryOct 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 BIOZORB PROCEDURE WAS PERFORMED, AND THE PATIENT REPORTED SUFFERED FROM IRRITATION, SWELLING, REDDENING OF THE SKIN, PAIN, ITCHING, DISCOMFORT, AND DIFFICULTY SLEEPING. THE PATIENT REPORTED HAVING THE BIOZORB DEVICE REMOVED ON OR AROUND (B)(6) 2023. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Bacterial Infection; Breast Discomfort/Pain; Erythema; Hypersensitivity/Allergic reaction; Itching Sensation; Rash; Scar Tissue; Seroma; Sleep Dysfunction; Swelling/ Edema

  MAUDE report 17881197 ↗
• 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 BILATERAL BREAST LUMPECTOMY IN WHICH TWO BIOZORB DEVICE WERE IMPLANTED. PATIENT HAD A PRIOR DIAGNOSIS OF MALIGNANT NEOPLASM ON HER LEFT BREAST, UNSPECIFIED ESTROGEN RECEPTOR STATUS AND UNSPECIFIED LOCATION. PATIENT REPORTED THAT ONE YEAR AFTER THE IMPLANTATION OF THE DEVICES SHE IS EXPERIENCING PAIN BILATERALLY. THE PATIENT WAS COUNSELLED BY A RADIOLOGIST THAT THE BIOZORB WERE STILL PRESENT IN HER BREAST ONE YEAR AFTER THE IMPLANTATION. THE PATIENT REPORTED THAT IS IN CONSTANT PAIN AND IS SEEKING OPTIONS ON THE NEXT STEPS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Breast Discomfort/Pain; Swelling/ Edema

  MAUDE report 17691570 ↗