GORE-TEX Suture 6M02Recalls & reported problems
W. L. Gore & Associates, Inc. · GORE-TEX SUTURE CV-6 76cm 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
- 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 00733132629329), received between Feb 11, 2020 and Aug 14, 2024 — classified as 3 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
- Fracture1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2024Fracture; Fracture
IT WAS REPORTED TO GORE THAT ON (B)(6) 2024, A PATIENT WAS TO BE USED WITH GORE-TEX® SUTURE (6M02A)) DURING PROCEDURE. THE SUTURE AIMED TO SUTURE VASCULAR GRAFT (GORE, RRT08070070L). BUT THE SUTURE WAS BROKEN IMMEDIATELY WHEN PHYSICIAN WAS ATTEMPTING TO SLIP THE KNOB AFTER PUNCTURING THE VASCULAR GRAFT. ANOTHER SUTURE OF SAME MODEL WAS USED TO SUCCESSFULLY COMPLETE THE SURGERY. THE PATIENT'S CONDITION REMAINED STABLE AFTER SURGERY WITHOUT ANY ADVERSE REACTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19979086 ↗MalfunctionFeb 11, 2020Material Frayed; Material Frayed
IT WAS REPORTED TO GORE THAT DURING CAROTID CASES USING GORE-TEX® SUTURE, SEVERAL SUTURES FRAYED. NO PATIENT HARM WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9694207 ↗MalfunctionFeb 11, 2020Material Frayed; Material Frayed
IT WAS REPORTED TO GORE THAT DURING CAROTID CASES USING GORE-TEX® SUTURE, SEVERAL SUTURES FRAYED. NO PATIENT HARM WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9694197 ↗
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- 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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