GORE-TEX Suture 0N05Recalls & reported problems
W. L. Gore & Associates, Inc. · GORE-TEX SUTURE CV-0 91cm SingleArm THX-26-1dz · Class 2 · Implant
All models of GORE-TEX Suture (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132625789), received between Oct 6, 2020 and Oct 6, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (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.
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Fluid Discharge1
- Foreign Body In Patient1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 6, 2020Use of Device Problem; Use of Device Problem
THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019, DURING THE PROCEDURE OF RHINOPLASTY, PHYSICIAN A USED A GORE-TEX® SUTURE TO SUTURE ON THE PATIENT¿S NOSE AND FOREHEAD. AFTER THE PROCEDURE, THE PATIENT FOUND THERE WAS UNKNOWN FLUID FLOWED FROM THE NOSE AND TOLD TO PHYSICIAN (B)(6). PHYSICIAN (B)(6) APPLIED SOME MEDICINE TO THE PATIENT AND CONFIRMED THAT PATIENT'S SYMPTOMS WERE FINE. HOWEVER, THE PATIENT'S SYMPTOMS DIDN'T IMPROVE AND WERE EVEN WORSENED, NOT ONLY THE AFFECTED AREA BECAME MORE PAINFUL, BUT ALSO THE NOSE WAS ATROPHY. ON (B)(6) 2020, THE PATIENT WENT TO HOSPITAL FOR REVIEW. AND ON (B)(6) 2020, PHYSICIAN (B)(6) FROM OTHER HOSPITAL PERFORMED FOREIGN BODY AND GORE-TEX® SUTURE REMOVAL, AND REPAIRED OF SEPTAL PERFORATION BY MUCOSAL FLAP. THE SUTURE WAS BROKEN WHEN PHYSICIAN (B)(6) CUT IT FOR REMOVING. AFTER THIS OPERATION, THE PATIENT'S PAIN WAS RELIEVED SLIGHTLY. HOWEVER, THE PATIENT'S NOSE HAS BEEN DEFORMED DUE TO MUSCLE ATROPHY. BEFORE THIS OPERATION, THE PATIENT WENT TO ANOTHER CLINIC FOR CONSULTATION. IT WAS DIAGNOSED THAT THE PATIENT WAS SUFFERING FROM INFECTION OF THE NOSE TISSUE. THIS INFECTION WAS SUSPICIOUSLY CAUSED BY PHYSICIAN A'S PROCEDURE OFF-LABEL USE AND TH
Patient problems: Fluid Discharge; Foreign Body In Patient; Pain; Unspecified Infection
MAUDE report 10639589 ↗
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE devices
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- PROLENE 8805HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death209 reports
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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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