GalaFLEX Scaffold 100035-23Recalls & reported problems
Tepha, Inc. · GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB). · Class 2 · Implant
All models of GalaFLEX Scaffold (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00855920006058), received between Jun 8, 2022 and Jun 8, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 reports).
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.
Most reported problems
Device problems
- Patient-Device Incompatibility2
Patient problems
- Impaired Healing2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 8, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
PER CLINICAL TRIAL CP-1060: ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL SUPERIOR BREAST REDUCTION USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFLEX (DEVICE #1 AND DEVICE #2) WERE USED. CONCOMITANT PROCEDURES INCLUDED LIPOSUCTION OF LATERAL BREASTS AND CHIN. ON (B)(6) 2017, DELAYED WOUND HEALING OF BILATERAL BREASTS AT T JUNCTION OF INCISIONS WAS REPORTED. PATIENT DID NOT RECEIVE ANY TREATMENT/MEDICATION. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED AE IS LIKELY RELATED TO THE DEVICE AND NOT SERIOUS.
Patient problems: Impaired Healing
MAUDE report 14636562 ↗MalfunctionJun 8, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
PER CLINICAL TRIAL CP-1060: ON (B)(6) 2017, PATIENT UNDERWENT BILATERAL SUPERIOR BREAST REDUCTION USING A FULL VERTICAL AND HORIZONTAL T INCISION. 2 PIECES OF GALAFLEX (DEVICE #1 AND DEVICE #2) WERE USED. CONCOMITANT PROCEDURES INCLUDED LIPOSUCTION OF LATERAL BREASTS AND CHIN. ON (B)(6) 2017, DELAYED WOUND HEALING OF BILATERAL BREASTS AT T JUNCTION OF INCISIONS WAS REPORTED. PATIENT DID NOT RECEIVE ANY TREATMENT/MEDICATION. RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018. REVIEW BY MEDICAL AFFAIRS IDENTIFIES THE REPORTED AE IS LIKELY RELATED TO THE DEVICE AND NOT SERIOUS.
Patient problems: Impaired Healing
MAUDE report 14636536 ↗
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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