GORE-TEX Suture 3N07Recalls & reported problems
W. L. Gore & Associates, Inc. · GORE-TEX SUTURE CV-3 91cm SingleArm TH-26-1dz · Class 2 · Implant
All models of GORE-TEX Suture (19)
Data updated Oct 16, 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 00733132628711), received between Mar 25, 2024 and Mar 25, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Frayed” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Frayed2
Patient problems
- Wound Dehiscence2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2024Material Frayed; Material Frayed
IT WAS REPORTED THE PHYSICIAN USED THE GORE-TEX® SUTURE. REPORTEDLY, THE FIRST SUTURE START FRAYING, THEN A SECOND SUTURE WAS USED AND IT START FRAYING AS WELL. IT WAS REPORTED THE 3RD SUTURE USED WORKED FINE. REPORTEDLY, THE PROCEDURE BEING PERFORMED WAS AUGMENTATION-MASTOPEXY. IT WAS REPORTED, THE SURGEON THOUGHT BECAUSE THE FRAY WAS AT THE END OF THE SUTURE THE PROXIMAL PORTION WOULD BE OK. IT SUBSEQUENTLY FRAYED IN THE PATIENTS BODY. REPORTEDLY, A DEHISCENCE ALONG THE SURGICAL INCISION OCCURRED, BUT WAS REPAIRED WITH ADDITIONAL SUTURES.
Patient problems: Wound Dehiscence
MAUDE report 18975214 ↗MalfunctionMar 25, 2024Material Frayed; Material Frayed
IT WAS REPORTED THE PHYSICIAN USED THE GORE-TEX® SUTURE. REPORTEDLY, THE FIRST SUTURE START FRAYING, THEN A SECOND SUTURE WAS USED AND IT START FRAYING AS WELL. IT WAS REPORTED THE 3RD SUTURE USED WORKED FINE. REPORTEDLY, THE PROCEDURE BEING PERFORMED WAS AUGMENTATION-MASTOPEXY. IT WAS REPORTED, THE SURGEON THOUGHT BECAUSE THE FRAY WAS AT THE END OF THE SUTURE THE PROXIMAL PORTION WOULD BE OK. IT SUBSEQUENTLY FRAYED IN THE PATIENTS BODY. REPORTEDLY, A DEHISCENCE ALONG THE SURGICAL INCISION OCCURRED, BUT WAS REPAIRED WITH ADDITIONAL SUTURES.
Patient problems: Wound Dehiscence
MAUDE report 18974391 ↗
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- PROLENE 8805HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death209 reports
- PROLENE 8521HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 deaths183 reports
- PROLENE 8735HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE163 reports
- PROLENE 8711HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall89 reports
- PROLENE 9702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE130 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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