Powerflex™ Pectoral Implant Size 4, RightRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M724ACPI4R1), received between Feb 8, 2017 and Mar 24, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2017Insufficient Device Problem Information

  COMPLAINANT REPORTED THAT AFTER EXPLANT AND IMMEDIATE REPLACEMENT OF PRIOR RIGHT SIDE PECTORAL IMPLANT (REFER TO MDR# 2028924-2017-00001), THAT THE PATIENT HAS HAD CONTINUING PROBLEMS WITH RECURRING SEROMAS ON THE RIGHT SIDE. APPROXIMATELY 6 WEEKS AFTER REPLACEMENT DEVICE WAS IMPLANTED, THE PECTORAL IMPLANTS WERE EXPLANTED BILATERALLY DUE TO THE RECURRING SEROMAS ON THE RIGHT SIDE. IMPLANTECH HAS ELECTED TO REPORT THIS EVENT ALTHOUGH THE PATIENT SYMPTOMOLOGY THAT LED TO THE REPORTABLE INTERVENTION WAS PRESENT IN THE PATIENT PRIOR TO THE DEVICE BEING IMPLANTED.

  Patient problems: Seroma

  MAUDE report 6431805 ↗
• InjuryFeb 8, 2017Patient-Device Incompatibility

  COMPLAINANT REPORTED THAT PATIENT WHO HAD A PREVIOUS SET OF PECTORAL IMPLANTS, HAD THEM REPLACED WITH IMPLANTECH PECTORAL IMPLANTS. THE PATIENT SUBSEQUENTLY DEVELOPED RECURRING SEROMAS ON THE RIGHT SIDE ONLY WHICH WERE INITIALLY REPORTED BY THE PATIENT APPROXIMATELY 14 WEEKS POST-OPERATIVELY. THE PATIENT SUBSEQUENTLY ELECTED TO HAVE ONLY THE RIGHT SIDE IMPLANT EXPLANTED AND IMMEDIATELY REPLACED APPROXIMATELY 24 WEEKS POST-OPERATIVELY. IMPLANTECH FOLLOWED UP TO CHECK THE STATUS OF THE PATIENT 3 WEEKS AFTER REPLACEMENT SURGERY, AND THE COMPLAINANT REPORTED THAT THE PATIENT WAS STILL HAVE PROBLEMS WITH SEROMAS ON THE RIGHT SIDE. THE PATIENT CURRENTLY PLANS TO HAVE IMPLANTS ON BOTH SIDES REMOVED WITHOUT IMMEDIATE REPLACEMENT. (IMPLANTECH HAS INITIATED A NEW COMPLAINT FILE TO INVESTIGATE THE NEW EVENT.)

  Patient problems: Failure of Implant; Seroma

  MAUDE report 6311605 ↗