GalaFLEX LITE 100027-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810054980636), received between Jul 19, 2024 and Aug 12, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  PER JOURNAL ARTICLE, "PLASTIC AND RECONSTRUCTIVE SURGERY ADVANCE ONLINE ARTICLE - THE GALAFLEX ¿EMPANADA¿ FOR DIRECT TO IMPLANT PREFECTORAL BREAST RECONSTRUCTION". THIS ARTICLE IS A DESCRIPTION OF TECHNIQUE FOR IMMEDIATE PREFECTORAL IMPLANT-BASED BREAST RECONSTRUCTION USING A BREAST IMPLANT CIRCUMFERENTIALLY WRAPPED IN GALAFLEX AND EFFECTIVELY CREATES A TEMPORARY TEXTURED IMPLANT AND IS USEFUL FOR SECURING THE IMPLANT IN THE PREFECTORAL BREAST POCKET WITH THE AIM OF MINIMIZING POSTOPERATIVE COMPLICATIONS, INCLUDING SEROMA. IT WAS REPORTED THAT THIS TECHNIQUE CAN BE UTILIZED WITH BOTH NIPPLE-SPARING AND SKIN-SPARING MASTECTOMIES AND ANY INCISION PATTERN. THE HEALTH PROFESSIONALS TYPICALLY USE 15-CENTIMETER OF GALAFLEX LITE FOR IMPLANTS UP TO 300 CC OR 12 CENTIMETER IN DIAMETER, 17-CENTIMETER OF GALAFLEX LITE FOR BREAST IMPLANTS UP TO 485 CC OR 14 CENTIMETER IN DIAMETER AND 19 CM GALAFLEX LITE FOR LARGER BREAST IMPLANTS. IT WAS REPORTED THAT GALAFLEX 'EMPANADA' WAS A MECHANISM TO HELP SECURE THE IMPLANT IN PREFECTORAL PLANE AND REDUCE SUBSEQUENT MICROMOVEMENTS OF THE IMPLANT. IT WAS REPORTED THAT GALAFLEX 'EMPANADA' WAS A RELIABLE METHOD FOR REDUCING DELAYED SEROMA FORMATION AND STAB

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 19960434 ↗
• InjuryJul 19, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  PER JOURNAL ARTICLE, "PLASTIC AND RECONSTRUCTIVE SURGERY ADVANCE ONLINE ARTICLE - THE GALAFLEX ¿EMPANADA¿ FOR DIRECT TO IMPLANT PREPECTORAL BREAST RECONSTRUCTION". THIS ARTICLE IS A DESCRIPTION OF TECHNIQUE FOR IMMEDIATE PREPECTORAL IMPLANT-BASED BREAST RECONSTRUCTION USING A BREAST IMPLANT CIRCUMFERENTIALLY WRAPPED IN GALAFLEX AND EFFECTIVELY CREATES A TEMPORARY TEXTURED IMPLANT AND IS USEFUL FOR SECURING THE IMPLANT IN THE PREPECTORAL BREAST POCKET WITH THE AIM OF MINIMIZING POSTOPERATIVE COMPLICATIONS, INCLUDING SEROMA. IT WAS REPORTED THAT THIS TECHNIQUE CAN BE UTILIZED WITH BOTH NIPPLE-SPARING AND SKIN-SPARING MASTECTOMIES AND ANY INCISION PATTERN. THE HEALTH PROFESSIONALS TYPICALLY USE 15-CENTIMETER OF GALAFLEX LITE FOR IMPLANTS UP TO 300 CC OR 12 CENTIMETER IN DIAMETER, 17-CENTIMETER OF GALAFLEX LITE FOR BREAST IMPLANTS UP TO 485 CC OR 14 CENTIMETER IN DIAMETER AND 19 CM GALAFLEX LITE FOR LARGER BREAST IMPLANTS. IT WAS REPORTED THAT GALAFLEX 'EMPANADA' WAS A MECHANISM TO HELP SECURE THE IMPLANT IN PREPECTORAL PLANE AND REDUCE SUBSEQUENT MICROMOVEMENTS OF THE IMPLANT. IT WAS REPORTED THAT GALAFLEX 'EMPANADA' WAS A RELIABLE METHOD FOR REDUCING DELAYED SEROMA FORMATION AND STAB

  Patient problems: Necrosis; Seroma; Wound Dehiscence

  MAUDE report 19781595 ↗