Pectoralis Implant ACP 2-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B049ACP220), received between Aug 11, 2021 and Aug 11, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  A PATIENT HAD HANSON MEDICAL PECTORALIS IMPLANTS (HMI PART # ACP 2 - 2, PAIR / LOT # 18309) IMPLANTED ON (B)(6) 2021 BY DR. (B)(6). THE COMPLAINT NOTES INDICATE THAT THE PECTORALIS IMPLANTS WERE STERILIZED AT THE SURGERY CENTER, HOWEVER, NO RECORD OR METHOD OF STERILIZATION COULD BE PROVIDED. THE PATIENT COMPLAINED NUMEROUS TIMES TO DR. SHAH THAT HE WAS EXPERIENCING A RASH (BILATERALLY) WHICH WAS PROGRESSING EXTENSIVELY. THE PATIENT WAS TREATED WITH MEDROL DOSEPAK AND ANTIBIOTICS WITH NO IMPROVEMENT. THE PATIENT HAD SUBSEQUENT OFFICE VISITS ON (B)(6) 2021. THE IMPLANTS WERE REMOVED (EXPLANTED) ON (B)(6) 2021. HANSON MEDICAL WAS FIRST NOTIFIED OF THIS ISSUE ON JULY 12, 2021.

  Patient problems: Rash

  MAUDE report 12307523 ↗