GORE-TEX Suture 6K02Recalls & reported problems
W. L. Gore & Associates, Inc. · GORE-TEX SUTURE CV-6 61cm DoubleArm TTc-9-1dz · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132629268), received between Oct 30, 2019 and Oct 30, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2019Break; Break
ON (B)(6) 2019 THE PATIENT UNDERWENT ARTERIOVENOUS GRAFT PLACEMENT FOR HEMODIALYSIS USING GORE-TEX® SUTURE. IT WAS REPORTED THAT THE SUTURE FRAYED AND BROKE INTRAOPERATIVELY, AND THE NEEDLE BECAME DISENGAGED. REPORTEDLY ENOUGH THROWS WERE TIED SO THAT THE SUTURE STAYED IN PLACE UPON BREAKING AND ALL KNOTS REPORTEDLY REMAINED INTACT. THE PHYSICIAN TIED OFF AT THE POINT OF THE SUTURE BREAK. THE NEEDLE WAS REMOVED AND DID NOT REMAIN IN THE PATIENT. IT WAS REPORTED THAT THE PHYSICIAN IS A FREQUENT USER OF THE GORE-TEX® SUTURE AND HAS MUCH PRACTICE WITH THE USE OF THE DEVICE. REPORTEDLY THE PHYSICIAN DID NOT HAVE A SUSPECTED REASON FOR WHY THE SUTURE FRAYED AND BROKE. ANOTHER GORE-TEX® SUTURE FROM A DIFFERENT LOT WAS OBTAINED TO COMPLETE THE PROCEDURE. THERE WERE NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9258419 ↗
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE devices
- PROLENE 8706HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 recalls294 reports
- PROLENE 8702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 deaths254 reports
- 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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