GORE-TEX Suture Oral Health P5K17Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00733132628506), received between Jul 18, 2018 and May 8, 2023 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (8 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

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• MalfunctionJul 18, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  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 7697497 ↗
• MalfunctionJul 18, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  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 7697491 ↗