GalaFLEX LITE 100027-10Recalls & reported problems
Tepha, Inc. · GalaFLEX LITE Scaffold, 25.0 cm x 30.0 cm, Rectangle · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810054980827), received between Apr 2, 2024 and Apr 2, 2024 — classified as 2 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Patient-Device Incompatibility1
Patient problems
- Bacterial Infection1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 2, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
AS REPORTED, THE PATIENT UNDERWENT BILATERAL IMPLANT EXCHANGE AND MASTOPEXY PROCEDURE WITH THE IMPLANT OF TWO GALAFLEX LITE MESHES IN LEFT AND RIGHT BREASTS ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH STAPHYLOCOCCUS INFECTION IN THE LEFT BREAST AND UNDERWENT REVISION SURGERY BY REMOVING THE GALAFLEX LITE MESHES FROM BOTH BREASTS ON (B)(6) 2023. THE SURGEON DOES NOT KNOW WHAT COULD HAVE CAUSED THE PATIENT'S INFECTION. IT WAS REPORTED THAT PATIENT WAS TREATED WITH IV ANTIBIOTICS AND THE INFECTION WAS CLEARED.
Patient problems: Bacterial Infection
MAUDE report 19024496 ↗InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED, THE PATIENT UNDERWENT BILATERAL IMPLANT EXCHANGE AND MASTOPEXY PROCEDURE WITH THE IMPLANT OF TWO GALAFLEX LITE MESHES IN LEFT AND RIGHT BREASTS ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH STAPHYLOCOCCUS INFECTION IN THE LEFT BREAST AND UNDERWENT REVISION SURGERY BY REMOVING THE GALAFLEX LITE MESHES FROM BOTH THE LEFT AND RIGHT BREASTS ON (B)(6) 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19021454 ↗
Other Surgical Film devices
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- GalaFLEX Scaffold 100035-15Tepha, Inc. · Surgical Film64 reports
- GalaFORM 3D 100043-02Tepha, Inc. · Surgical Film41 reports
- Phasix 1190500Davol Inc. · surgical film39 reports
- GalaSHAPE 3D 100042-04Tepha, Inc. · Surgical Film37 reports
- GalaFORM 3D 100043-04Tepha, Inc. · Surgical Film29 reports
- Phasix 1190400Davol Inc. · surgical film26 reports
- Phasix 1190200Davol Inc. · surgical film22 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.