GalaFLEX 3D 100042-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810054980285), received between May 9, 2024 and May 9, 2024 — classified as 2 injuries.

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

1 other recall cover devices cleared under the same FDA submission (K161092); they may or may not involve this specific model.

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.

• InjuryMay 9, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT A BILATERAL MASTOPEXY WITH BREAST IMPLANTS AND A GALAFLEX 3D. IT WAS REPORTED THAT THE PATIENT EXPERIENCED BILATERAL INCISIONAL WOUND DEHISCENCE POST-OPERATIVELY. THE PATIENT WAS TREATED WITH WOUND CARE AND THE RIGHT BREAST WAS HEALED; HOWEVER, ON THE LEFT BREAST SIDE, THE WOUND REMAINS OPEN AND DID NOT APPEAR TO BE INCORPORATING. AS REPORTED, SURGEON IS CONSIDERING A REVISION PROCEDURE TO POSSIBLY REMOVE THE MESH BILATERALLY.

  Patient problems: Wound Dehiscence

  MAUDE report 19277643 ↗
• InjuryMay 9, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT A BILATERAL MASTOPEXY WITH BREAST IMPLANTS AND A GALAFLEX 3D. IT WAS REPORTED THAT THE PATIENT EXPERIENCED BILATERAL INCISIONAL WOUND DEHISCENCE POST-OPERATIVELY. THE PATIENT WAS TREATED WITH WOUND CARE AND THE RIGHT BREAST WAS HEALED; HOWEVER, ON THE LEFT BREAST SIDE, THE WOUND REMAINS OPEN AND DID NOT APPEAR TO BE INCORPORATING. AS REPORTED, SURGEON IS CONSIDERING A REVISION PROCEDURE TO POSSIBLY REMOVE THE MESH BILATERALLY.

  Patient problems: Wound Dehiscence

  MAUDE report 19277642 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161092. One submission often covers many models, so check the product and lot details in each record.

• Z-0948-2017 · Nov 21, 2016 · Terminated
  GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce de