GORE-TEX Suture Oral HealthRecalls & reported problems across all models
W. L. Gore & Associates, Inc. · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 4 models of GORE-TEX Suture Oral Health by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Jul 18, 2018 and Feb 19, 2025 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Break” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported GORE-TEX Suture Oral Health problems
Device problems
- Break9
- Material Separation6
- Separation Problem3
- Detachment of Device or Device Component2
Patient problems
- No Known Impact Or Consequence To Patient12
- No Consequences Or Impact To Patient6
- No Clinical Signs, Symptoms or Conditions2
GORE-TEX Suture Oral Health models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GORE-TEX Suture Oral Health P5K17SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE11 reports
- GORE-TEX Suture Oral Health P5K23SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE5 reports
- GORE-TEX Suture Oral Health P7K13SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 reports
- GORE-TEX Suture Oral Health P6K23SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
Recent GORE-TEX Suture Oral Health adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionMay 8, 2023Break; Break
IT WAS REPORTED TO GORE THAT DURING AN IMPLANT PROCEDURE OUT OF ONE PACKAGE OF GORE-TEX® SUTURE FOR ORAL HEALTH, FOUR THREADS TORE OFF THE NEEDLE DURING A DENTAL PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY OPENING AND USING A NEW THREAT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16885487 ↗MalfunctionJan 22, 2020Break; Break
IT WAS REPORTED TO GORE THAT THE GORE-TEX® SUTURE CV-5 (P5K17A) CHANGED FROM A MORE FLAT FORM TO A ROUND AND THINNER FORM THAT EASILY BREAKS. THE PHYSICIAN DID CHANGE TO A P4K13A IN HOPES THAT IT IS STRONGER AND MORE RESISTANT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9616628 ↗MalfunctionDec 5, 2019Break; Break
IT WAS REPORTED TO GORE THAT DURING SUTURING OF A LESION IN THE MOUTH USING GORE-TEX® SUTURE, THE SUTURE APPEARED TO GET LONGER AND THINNER UNTIL IT SEPARATED INTO TWO PIECES. IT WAS REPORTED THE PROCEDURE WAS COMPLETED USING A NEW SUTURE AND THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9416813 ↗MalfunctionDec 3, 2019Break; Break
IT WAS REPORTED TO GORE THAT THE GORE-TEX® SUTURE CV-5 (P5K17A) CHANGED FROM A MORE FLAT FORM TO A ROUND AND THINNER FORM THAT EASILY BREAKS. THE PHYSICIAN DID CHANGE TO A P4K13A IN HOPES THAT IT IS STRONGER AND MORE RESISTANT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9401891 ↗MalfunctionDec 2, 2019Break; Break
IT WAS REPORTED TO GORE THAT 5 GORE-TEX® SUTURE CV-5 WERE TORN DIRECT AT THE NEEDLE DURING EXTRACTING THE NEEDLE OUT OF THE TISSUE (DURING SUTURING).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9399555 ↗MalfunctionDec 2, 2019Break; Break
IT WAS REPORTED TO GORE THAT 5 GORE-TEX® SUTURE CV-5 WERE TORN DIRECT AT THE NEEDLE DURING EXTRACTING THE NEEDLE OUT OF THE TISSUE (DURING SUTURING).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9399395 ↗MalfunctionAug 20, 2019Break; Break
A DENTAL OFFICE REPORTED TO GORE THAT A GORE-TEX® SUTURE BROKE DURING THE MIDDLE OF USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8910810 ↗MalfunctionAug 1, 2019Break; Break
IT WAS REPORTED TO GORE THAT DURING A RIDGE AUGMENTATION PROCEDURE USING GORE-TEX® SUTURE, THE SUTURE DETACHED FROM THE NEEDLE DURING SUTURING. IT WAS REPORTED THE SURGEON USED ANOTHER SUTURE FROM THE SAME LOT TO COMPLETE THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8850831 ↗MalfunctionJul 3, 2019Break; Break
IT WAS REPORTED TO GORE THAT DURING A GINGIVAL GRAFT PROCEDURE, ONE OF THE GORE-TEX® SUTURE FOR ORAL HEALTH (P5K17A) KEPT BREAKING. IT WAS REPORTED WHEN THEY TRIED TO TIE THE SUTURE, IT WOULD BREAK CLOSE TO THE NEEDLE. THE SURGEON USED ANOTHER SUTURE TO COMPLETE THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8761368 ↗MalfunctionMar 22, 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 BENT WAS EXPERIENCED AT THE FIRST NEEDLE PUNCTURE. IT WAS STATED THAT THEREFORE A SECOND GORE-TEX® SUTURE WAS USED WHERE IT WAS REPORTED THAT A NEEDLE PULL OFF OCCURRED DURING THE PROCEDURE. THE OCCURRENCES 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 8442911 ↗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 ↗
Other W. L. Gore & Associates, Inc. products
- GORE EXCLUDER AAA Endoprosthesis81 models · 1,121 reports
- GORE DRYSEAL FLEX Introducer Sheath29 models · 1,009 reports
- GORE EXCLUDER AAA Endoprosthesis with C3 Delivery51 models · 988 reports
- GORE DUALMESH PLUS BIOMATERIAL12 models · 734 reports
- GORE VIABAHN VBX Balloon Expandable Endo111 models · 557 reports · 1 recall
- GORE DUALMESH Biomaterial13 models · 485 reports
- GORE EXCLUDER Iliac Branch Endoprosthesis6 models · 469 reports
- GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral10 models · 427 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page