GORE-TEX Suture 2U17Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132628636), received between Oct 9, 2023 and Nov 15, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2023Loss of or Failure to Bond; Material Separation; Loss of or Failure to Bond; Material Separation

  IT WAS REPORTED TO GORE THAT THE PATIENT WAS TREATED WITHIN AN LAPAROSCOPIC PROCEDURE FOR A LARGE HIATAL HERNIA REOCURRENCE. IT WAS STATED THAT THE GORE-TEX®SUTURE THREAD SEPARATED FROM THE NEEDLE. IT WAS STATED THAT THE NEEDLE WAS PULLED UP THROUGH THE 5MM TROCAR NEEDLE HOLDER (NON-GORE DEVICE), GRASPED WITH FORCEPS AND ATTEMPTED TO BE REMOVED. REPORTEDLY THE NEEDLE GOT STUCK IN THE PERITONEUM AND WAS FOUND AFTER TRANSLUCENCY AND GOT REMOVED. A LONGER INTERVENTION TIME DUE TO THE SLIGHTLY EXTENDED INCISION AND THE USE OF TRANSILLUMINATION WAS REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18138821 ↗
• MalfunctionOct 9, 2023Loss of or Failure to Bond; Material Separation; Loss of or Failure to Bond; Material Separation

  IT WAS REPORTED TO GORE THAT THE PATIENT PRESENTED WITH A HIATAL HERNIA WAS TREATED WITHIN AN LAPAROSCOPIC PROCEDURE. IT WAS STATED THAT THE GORE-TEX® SUTURE SEPARATED FROM THE THREAD. REPORTEDLY THE USED NEEDLE HOLDER WAS PLACED ON THE THREAD APPROXIMATELY 1.5 CM FROM THE NEEDLE, AFTER WHICH THE SUTURE AND THE NEEDLE HOLDER WERE LED THROUGH A PORT INTO THE PATIENT'S ABDOMEN. REPORTEDLY THE NEEDLE DROPPED OF THE THREAD WHEN THE NEEDLE HOLDER CAME THROUGH THE PORT. THE NEEDLE LANDED INSIDE THE PATIENT. IT WAS STATED THAT THE NEEDLE WAS FOUND IN THE PATIENT, WAS REMOVED SUCCESSFULLY AND THE INTERVENTION WAS COMPLETED BY USING AN IDENTICAL GORE-TEX® SUTURE. A LONGER INTERVENTION TIME HAS BEEN REPORTED, NO FURTHER CONSEQUENCES HAVE BEEN REPORTED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17894398 ↗