GalaFLEX LITE 100027-33Recalls & reported problems
Tepha, Inc. · GalaFLEX LITE Scaffold, 22.0 cm, Circle · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810054980797), received between Apr 22, 2026 and May 11, 2026 — classified as 1 injury, 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
- Patient-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Rash1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Device Contamination with Chemical or Other Material
AS REPORTED, DURING A BREAST RECONSTRUCTION PROCEDURE AFTER MASTECTOMY, A "HAIR" WAS FOUND IN THE GALAFLEX LITE PACKAGING. ANOTHER PRODUCT WAS USED FOR THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25136714 ↗InjuryApr 22, 2026Patient-Device Incompatibility
AS REPORTED ON 01-FEB-2026, THE PATIENT UNDERWENT IMPLANT OF GALAFLEX LITE. POST TWO (2) WEEKS OF IMPLANTATION THE PATIENT HAD EXPERIENCED FULL BODY RASHES. REPORTEDLY, THE PATIENT HAD NO KNOWN ALLERGIES BEFORE. THE PATIENT WAS TREATED WITH TOPICAL OINTMENTS AND STEROIDS WITH NO RESOLUTION OF THE RASH. THE PATIENT UNDERWENT REACTIVITY TESTING WITH THE PROVIDED GALAFLEX SAMPLE. THE REACTIVITY TEST WAS NEGATIVE, AND THE PATIENT HAD NO SENSITIVITIES TO ANY OF THE SURGICAL PRODUCTS TESTED. AS PER THE ALLERGIST, THEY WILL ATTEMPT TESTING OF THE SILICONE IMPLANT MATERIAL AS THIS WAS THE LAST MATERIAL TO BE TESTED.
Patient problems: Rash
MAUDE report 24948774 ↗
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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