GalaFLEX LITE GFLT0019BDRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741233814), received between Feb 13, 2026 and Feb 13, 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.

• InjuryFeb 13, 2026Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT LEFT MASTECTOMY RECONSTRUCTION ON (B)(6) 2025 USING GALAFLEX LITE, POST IMPLANT OF THE MESH THE PATIENT EXPERIENCED ERYTHEMA OBSERVED ON THE LEFT BREAST AND ALONG WITH MILD NECROSIS. IT WAS ALSO REPORTED THAT AS PER THE CLINICAL ASSESSMENT, THE FINDING IS UNLIKELY TO BE RELATED TO THE USE OF GALAFLEX LITE. THE PATIENT IS CURRENTLY UNDER CLOSE CLINICAL MONITORING AND CONTINUED OBSERVATION. ADDITIONALLY, THE ERYTHEMA IS ABSENT WHEN THE PATIENT IS IN A SUPINE POSITION.

  Patient problems: Erythema; Necrosis

  MAUDE report 24331434 ↗