GORE-TEX Suture Oral Health P5K23Recalls & reported problems
W. L. Gore & Associates, Inc. · GORE-TEX SUTURE CV-5 61cm RT-18-1dz · Class 2 · Implant
All models of GORE-TEX Suture Oral Health (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132629923), received between Jan 14, 2019 and Feb 19, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Material Separation” (5 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.
Reports received per month
Most reported problems
Device problems
- Material Separation5
Patient problems
- No Known Impact Or Consequence To Patient4
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 19, 2025Material Separation; Material Separation
IT WAS REPORTED TO GORE THAT GORE-TEX® SUTURE WAS USED DURING A SURGICAL PROCEDURE AND BROKE (TEARING IN THE MIDDLE). THERE WAS NO IMPACT ON THE PATIENT AND NEW GORE-TEX® SUTURE WAS USED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21409989 ↗MalfunctionFeb 8, 2019Material Separation; Material Separation
IT WAS REPORTED TO GORE THAT WHEN A GORE-TEX® SUTURE WAS USED TO SUTURE A LESION IN THE PATIENT¿S MOUTH, A NEEDLE PULL OFF OCCURRED DURING THE PROCEDURE. THE OCCURRENCE DID NOT REQUIRE A REINTERVENTION AND NO FRAGMENTS REMAINED IN THE PATIENT¿S MOUTH.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8319608 ↗MalfunctionFeb 8, 2019Material Separation; Material Separation
IT WAS REPORTED TO GORE THAT WHEN A GORE-TEX® SUTURE WAS USED TO SUTURE A LESION IN THE PATIENT¿S MOUTH, A NEEDLE PULL OFF OCCURRED DURING THE PROCEDURE. THIS HAPPENED THREE TIMES WITH THREE SUTURES OF THE SAME LOT NUMBER EACH TIME. THE OCCURRENCE DID NOT REQUIRE A REINTERVENTION AND NO FRAGMENTS REMAINED IN THE PATIENT¿S MOUTH.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8319603 ↗MalfunctionFeb 8, 2019Material Separation; Material Separation
IT WAS REPORTED TO GORE THAT WHEN A GORE-TEX® SUTURE WAS USED TO SUTURE A LESION IN THE PATIENT¿S MOUTH, A NEEDLE PULL OFF OCCURRED DURING THE PROCEDURE. THIS HAPPENED THREE TIMES WITH THREE SUTURES OF THE SAME LOT NUMBER EACH TIME. THE OCCURRENCE DID NOT REQUIRE A REINTERVENTION AND NO FRAGMENTS REMAINED IN THE PATIENT¿S MOUTH.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8319599 ↗MalfunctionJan 14, 2019Material Separation; Material Separation
IT WAS REPORTED TO GORE THAT WHEN A GORE-TEX® SUTURE WAS USED TO SUTURE A LESION IN THE PATIENT¿S MOUTH, A NEEDLE PULL OFF OCCURRED DURING THE PROCEDURE. THIS HAPPENED THREE TIMES WITH THREE SUTURES OF THE SAME LOT NUMBER EACH TIME. THE OCCURRENCE DID NOT REQUIRE A REINTERVENTION AND NO FRAGMENTS REMAINED IN THE PATIENT¿S MOUTH.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8244127 ↗
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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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