GORE-TEX Suture 7M04Recalls & reported problems
W. L. Gore & Associates, Inc. · GORE-TEX SUTURE CV-7 76cm DoubleArm PT-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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132629787), received between Dec 12, 2018 and Oct 28, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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.
Most reported problems
Device problems
- Break3
Patient problems
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 28, 2020Break; Break
IT WAS REPORTED TO GORE THAT DURING AN ARTERIOVENOUS GRAFT (AVG) WHILE USING GORE-TEX® SUTURE, THE SUTURE BROKE WHEN THE PHYSICIAN WENT TO TIE IT. REPORTEDLY, UPON TYING THE FINAL KNOT, THE SUTURE BROKE ALONG THE COURSE OF THE ANASTOMOSIS, NOT AT THE KNOT. IT WAS REPORTED THE ANASTOMOSIS WAS REDONE. IT WAS REPORTED THE PROCEDURE WAS COMPLETED WITHOUT DIFFICULTY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10750908 ↗MalfunctionDec 12, 2018Break; Break
IT WAS REPORTED THAT WHEN THE GORE-TEX® SUTURES WERE OBSERVED THE THREAD BEING FLATTENED AFTER REMOVING FROM THE PACKAGE, AND THE NEEDLE WAS REPORTEDLY BROKEN DURING SEWING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8155049 ↗MalfunctionDec 12, 2018Break; Break
IT WAS REPORTED THAT WHEN THE GORE-TEX® SUTURES WERE OBSERVED THE THREAD BEING FLATTENED AFTER REMOVING FROM THE PACKAGE, AND THE NEEDLE WAS REPORTEDLY BROKEN DURING SEWING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8155043 ↗
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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