GalaFLEX LITE 100027-31Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810054980629), received between Sep 4, 2024 and Sep 4, 2024 — classified as 1 injury.

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

• InjurySep 4, 2024Migration; Migration

  AS REPORTED, THE PATIENT UNDERWENT BREAST REPAIR PROCEDURE WITH ONE PIECE OF THE GALAFLEX LITE 17 CM, CUT IT IN HALF AND USED THOSE PIECES TO SECURE THE IMPLANTS ON (B)(6) 2024. IT WAS REPORTED THAT THE CUT PIECES LIKELY WERE NOT LARGE ENOUGH TO PROPERLY SUPPORT THE 350CC IMPLANTS. IT WAS ALSO REPORTED THAT THE SCAFFOLD WAS SECURED TO THE CHEST WALL, BUT THE IMPLANTS HAVE MIGRATED TOGETHER, AND SO THE PATIENT WILL REQUIRE REVISION SURGERY TO CORRECT THE SITUATION WITH GALAFLEX AGAIN.

  Patient problems: Insufficient Information

  MAUDE report 20133720 ↗