GalaFLEX LITE 100027-09Recalls & reported problems
Tepha, Inc. · GalaFLEX LITE Scaffold, 15.0 cm x 20.0 cm, Rectangle · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810054980582), received between Aug 1, 2024 and May 7, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
- Migration1
- Patient-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Rash1
- Unspecified Reproductive System or Breast Problem1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2025Migration; Migration
AS REPORTED, PATIENT UNDERWENT SURGERY, THE GALAFLEX LITE SCAFFOLD WAS CUT IN HALF AND USED ½ EACH SIDE. THE PATIENT DEVELOPED SIGNIFICANT MALPOSITION PRESENTING AT THE 9 MONTH FOLLOW UP APPT ON (B)(6) 2025. THE REPORTED MALPOSITION WAS ON THE LEFT BREAST ONLY. PATIENT IS SCHEDULED FOR A REVISION SURGERY, AUGMENTATION W/ GALAFLEX PLACEMENT.
Patient problems: Unspecified Reproductive System or Breast Problem
MAUDE report 21977212 ↗InjuryApr 22, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
AS REPORTED, PATIENT UNDERWENT BREAST IMPLANT EXCHANGE WITH GALAFLEX LITE MESH ON (B)(6) 2025. IT WAS REPORTED THAT PATIENT DID A FULL BODY WASH WITH HIBICLENS PRIOR TO PROCEDURE DUE TO A HISTORY OF MRSA. ON THE DAY OF THE PROCEDURE 1GM OF VANCOMYCIN WAS GIVEN BEFORE INCISION AND INTRAOPERATIVE IRRIGATION WAS DONE WITH PHASEONE AND IMPLANTS SOAKED IN PVP-I. ON (B)(6) 2025, PATIENT WENT TO URGENT CARE WITH A RASH STARTING ON THE ELBOWS AND PROGRESSED TO THE EYES, EARS, LEGS, NECK, AND BACK OF SHOULDERS AND WAS TREATED WITH PREDNISONE, DEXAMETHASONE, BENADRYL, AND ZYRTEC. ON (B)(6), STILL PRESENTING WITH RASH. THE PATIENT SAW A THIRD ALLERGIST, RECEIVED A XOLAIR INJECTION, AND IT APPEARS TO BE HELPING.
Patient problems: Rash
MAUDE report 21881843 ↗MalfunctionAug 1, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
AS REPORTED, DURING A BREAST RECONSTRUCTION PROCEDURE, IT WAS FOUND THAT THERE WAS A FOREIGN MATERIAL (HAIR) INSIDE THE GALAFLEX LITE PACKAGE WHILE OPENING THE STERILE PACKAGING. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19885953 ↗
Other Surgical Film devices
- GalaFLEX Scaffold 100035-09Tepha, Inc. · Surgical Film2 deaths90 reports
- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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