GORE-TEX Suture 4N02Recalls & reported problems
W. L. Gore & Associates, Inc. · GORE-TEX SUTURE CV-4 91cm DoubleArm TH-18-1dz · Class 2 · Implant
All models of GORE-TEX Suture (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132628810), received between Nov 19, 2025 and Nov 19, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Degraded” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Degraded1
- Stretched1
Patient problems
- Mitral Valve Insufficiency/ Regurgitation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2025Degraded; Stretched; Degraded; Stretched
IT WAS REPORTED THAT THE PATIENT UNDERWENT MITRAL VALVE REPAIR SURGERY USING GORE-TEX® SUTURE (4N02A) FOR TENDON REPAIR ON (B)(6) 2025. AFTER THE SURGERY, IT WAS FOUND THAT THE MITRAL REGURGITATION HAD WORSENED, SO AN REINTERVENTION WAS PERFORMED ON THE SAME DAY. IT WAS OBSERVED THAT THE SUTURE THREAD 1.5 CM LONGER THAN ORIGINAL USED VISUALLY AFTER IT WAS REMOVED FROM PATIENT. THERE WAS NO SUTURE FRAY NOR BREAK OBSERVED. ANOTHER 4N02A SUTURE OF SAME LOT WAS TAKEN FOR IN VITRO TESTING, AND IT WAS FOUND THAT THE SUTURE COULD BE ELONGATED AND THERE WAS NO SUTURE FRAY NOR BREAK OBSERVED. THEREFORE, CV-5 SUTURE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. PATIENT TOLERATED THE PROCEDURE AND POSTOPERATIVE EXAMINATION WAS WELL.
Patient problems: Mitral Valve Insufficiency/ Regurgitation
MAUDE report 23601189 ↗
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE devices
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- PROLENE 8556HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death240 reports
- 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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