GORE-TEX Suture 7K04Recalls & reported problems
W. L. Gore & Associates, Inc. · GORE-TEX SUTURE CV-7 61cm 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132629749), received between Jan 15, 2026 and Jan 16, 2026 — classified as 2 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 Frayed2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2026Break; Material Frayed
IT WAS REPORTED TO GORE THAT ON (B)(6) 2025, A PATIENT WAS TO BE IMPLANTED WITH GORE-TEX® SUTURE TO PERFORM ARTERIOVENOUS FISTULA. TWO SUTURES WERE FORKED. ONE SUTURE WAS BROKEN DURING THE KNOTTING. THEREFORE, NEW SUTURE WAS UTILIZED. THE PROCEDURE WAS PROLONGED AND COMPLETED WITHOUT ADVERSE EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24091476 ↗MalfunctionJan 15, 2026Break; Material Frayed
IT WAS REPORTED TO GORE THAT ON (B)(6) 2025, A PATIENT WAS TO BE IMPLANTED WITH GORE-TEX® SUTURE TO PERFORM AUTOLOGOUS VASCULAR SURGERY. ONE SUTURE WAS FORKED. THE OTHER ONE WAS BROKEN DURING THE KNOTTING. TOTALLY TWO SUTURES WERE BROKEN. THE PROCEDURE WAS COMPLETED WITH NEW SUTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24090476 ↗
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE devices
- PROLENE 8706HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 recalls294 reports
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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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