GORE-TEX Suture 3200Recalls & reported problems
W. L. Gore & Associates, Inc. · GORE-TEX SUTURE CHORDAE TENDIN CV-4 91cm DoubleArm TH-22-1dz · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132628650), received between Jul 11, 2023 and Jun 5, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Detachment of Device or Device Component1
- Material Split, Cut or Torn1
Patient problems
- Mitral Valve Insufficiency/ Regurgitation1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED TO GORE THAT A GORE-TEX® SUTURE FOR CHORDAE TENDINEAE (4 DEVICES) BROKE DURING TYING OF THE KNOT DURING A TRICUSPID VALVE ANNULOPLASTY. THERE HAS BEEN NO CONSEQUENCES FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19467227 ↗InjuryJul 11, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT A MITRAL ANNULOPLASTY ON (B)(6) 2023 AND WAS TREATED WITH GORE-TEX® SUTURE FOR CHORDAE TENDINEAE. REPORTEDLY ON (B)(6) 2023 A REINTERVENTION WAS PERFORMED DUE TO THE IDENTIFICATION OF A MITRAL LEAK. IT WAS STATED THAT THE GORE-TEX® SUTURE FOR CHORDAE TENDINEAE HAD TORN OFF AND DISCOLORED YELLOWISH. THE PATIENT TOLERATED THE PROCEDURE AND RETURNED HOME. THE RESIDUES OF THE EXPLANTED THREADS ARE AVAILABLE FOR EVALUATION.
Patient problems: Mitral Valve Insufficiency/ Regurgitation
MAUDE report 17296483 ↗
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE devices
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- 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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