GalaFLEX 3DR 100043-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810054980025), received between Jun 3, 2026 and Jun 3, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION SURGERY ON (B)(6) 2021, DURING WHICH A GALAFLEX 3DR WAS IMPLANTED. ON (B)(6) 2026, THE GALAFLEX MESH WAS SURGICALLY EXCISED DUE TO THE REPORTED PAIN AND INJURY. PATIENT WAS INJURED SEVERELY AND PERMANENTLY. AS ALLEGED, THE PATIENT EXPERIENCED SURGICAL INTERVENTION, MENTAL ANGUISH AND PAIN. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE DEVICE WAS DEFECTIVE.

  Patient problems: Pain

  MAUDE report 25376214 ↗