GORE-TEX Suture 6M04Recalls & reported problems
W. L. Gore & Associates, Inc. · GORE-TEX SUTURE CV-6 76cm DoubleArm TTc-13-1dz · 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 00733132629336), received between Nov 19, 2019 and Nov 25, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Material Separation2
Patient problems
- Insufficient Information1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 25, 2024Break; Material Separation; Break; Material Separation
IT WAS REPORTED TO GORE THAT A GORE-TEX® SUTURE BROKE DURING A PROCEDURE. IT BROKE INSIDE A PATIENT DURING AN ONGOING SUTURING OF AN ANASTOMOSIS IN A NON-CALCIFIED VESSEL. THE PATIENT STATUS IS NOT DISCLOSED.
Patient problems: Insufficient Information
MAUDE report 20771464 ↗MalfunctionJul 7, 2020Material Separation; Material Separation
IT WAS REPORTED TO GORE THAT DURING SUTURING THE ANASTOMOSIS USING GORE-TEX® SUTURE, THE NEEDLES SEPARATED FROM THE THREAT. IT WAS STATED THAT NO NEEDLE OR SUTURE FRAGMENTS REMAINED IN THE PATIENT AND THAT THE PATIENT WAS NOT HARMED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10239157 ↗MalfunctionNov 19, 2019Break; Break
THE FOLLOWING WAS REPORTED TO GORE: DURING A FEM. TEA WITH BOVINE PATCH (A. FEMORALIS), THE GORE-TEX® SUTURE TORE FROM THE NEEDLE AFTER TWO STITCHES WERE COMPLETED. THE PROCEDURE WAS REPORTEDLY FINISHED WITH A SUTURE FROM A DIFFERENT LOT. IT WAS STATED THE PATIENT TOLERATED THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9340407 ↗
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- 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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