GORE-TEX Suture 4U06Recalls & reported problems
W. L. Gore & Associates, Inc. · GORE-TEX SUTURE CV-4 122cm DoubleArm TH-26-1dz · Class 2 · Implant
All models of GORE-TEX Suture (19)
Data updated Oct 18, 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 00733132628988), received between Mar 27, 2019 and Mar 27, 2019 — 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 18, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 27, 2019Break; Break
IT WAS REPORTED TO GORE THAT DURING AN ABDOMINAL AORTIC ANEURYSM RESECTION, A GORE-TEX® SUTURE WAS USED TO SUTURE A GORE-TEX® VASCULAR GRAFT TO THE ROOT OF THE MIDDLE ARTERY VESSELS. HOWEVER THE SUTURE WAS REPORTEDLY BROKEN DURING KNOT TYING. THEN THE PHYSICIAN USED THE REMAINING SUTURE TO TIE THE KNOT TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8456090 ↗MalfunctionMar 27, 2019Break; Break
IT WAS REPORTED TO GORE THAT DURING AN ABDOMINAL AORTIC ANEURYSM RESECTION, A GORE-TEX® SUTURE WAS USED TO SUTURE A GORE-TEX® VASCULAR GRAFT TO THE ROOT OF THE MIDDLE ARTERY VESSELS. HOWEVER THE SUTURE WAS REPORTEDLY BROKEN DURING KNOT TYING. THEN THE PHYSICIAN USED THE REMAINING SUTURE TO TIE THE KNOT TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8456085 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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