GalaFLEX 3D 100042-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810054980308), received between Mar 10, 2022 and Nov 12, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryNov 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT WAS IMPLANTED WITH GALAFLEX 3D DURING AN IMPLANT EXCHANGE PROCEDURE. IT WAS REPORTED THAT 5 MONTHS POST IMPLANTATION THE IMPLANT IN THE LEFT BREAST HAS SHIFTED LATERALLY AND INFERIORLY. THE SURGEON IS PLANNING TO REPLACE THE GALAFLEX WITH ANOTHER VERSION AND TO PERFORM ADDITIONAL INTERNAL TIGHTENING TO REPOSITION THE IMPLANT.

  Patient problems: Ptosis

  MAUDE report 23533791 ↗
• InjuryMar 10, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  PER CLINICAL TRIAL CP-1060: ON (B)(6) 2016, PATIENT UNDERWENT A REVISION LEFT SIDE CENTRAL MOUND BREAST MASTOPEXY/REDUCTION WITH A FULL VERTICAL AND HORIZONTAL T INCISION. CONCOMITANT PROCEDURES INCLUDED RIGHT REVISION AND FAT GRAFTING. ONE PIECE OF GALASHAPE (GALAFLEX 3D) WAS USED. ON (B)(6) 2016, MESH EXTRUSION WAS REPORTED. INCISION HAD DRAINAGE AND ODOR. PATIENT WAS INSTRUCTED HOW TO DO WET TO DRY DRESSING CHANGES TWICE DAILY. INCISION WAS RED AND TENDER. WITH DRESSING CHANGES, INCISION BEGAN TO FILL AND GRANULATE SLOWLY. ON (B)(6) 2017, PATIENT PRESENTED WITH INFECTION IN LEFT BREAST. DRESSING CHANGES CONTINUED. EXPOSED MESH WAS DEBRIDED ON BOTH (B)(6) 2017 AND (B)(6) 2017. AQUAPHOR OINTMENT APPLIED. EXCISION AND PRIMARY CLOSURE WITH MEDICATIONS (BACTRIM, BACTROBAN AND CIPRO) PERFORMED ON (B)(6) 2017. PROBLEM REPORTED TO HAVE RESOLVED ON (B)(6) 2017. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THIS AS RELATED TO THE DEVICE AND SERIOUS.

  Patient problems: Unspecified Infection

  MAUDE report 13724011 ↗

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