GORE-TEX Suture 2M25Recalls & reported problems
W. L. Gore & Associates, Inc. · GORE-TEX SUTURE CV-2 76cmSingleArm CS-65-1dz · Class 2 · Implant
All models of GORE-TEX Suture (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132628933), received between Aug 20, 2020 and Jun 3, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (4 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.
Reports received per month
Most reported problems
Device problems
- Break4
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2025Break; Break
IT WAS REPORTED BY THE CONSUMER THAT THE LAST BOX THEY HAD AVAILABLE OF THE GORE-TEX® SUTURE (ITEM 2M25A), 2 SUTURES SNAPPED ON THE DOCTOR UPON TYING. REPORTEDLY THEY HAD TO OPEN A NEW BOX FOR HIM. THE NEW BOX DID NOT SNAP ON HIM AFTER HAVING TO RUN HIS STITCH FOR THE 3RD TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22137572 ↗MalfunctionApr 22, 2022Break; Break
IT WAS REPORTED AS THE PHYSICIAN WAS PREPARING TO USE THE GORE-TEX® SUTURE TO SEW THE NIPPLE ON A PATIENT, THE SUTURE JUST FELL INTO PIECES. IT WAS REPORTED THIS OCCURRED WITH 2 SUTURES FROM THE SAME BOX. REPORTEDLY, ONE SUTURE COULD NOT BE KEPT FOR ANALYSIS AS IT FELL INTO TOO MANY PIECES. IT WAS REPORTED ONE WAS KEPT AND WILL BE SENT BACK FOR ANALYSIS. REPORTEDLY, THE PATIENT IS DOING WELL AND IS STABLE, HOWEVER THERE WAS SOME DELAY TO THE SURGERY BECAUSE OF THE INCIDENT. IT WAS REPORTED ANOTHER GORE SUTURE FROM ANOTHER BOX/LOT WHICH WORKED PERFECTLY. REPORTEDLY, THE CLIENT MISTAKENLY DISPOSED OF THE SUTURE THAT WAS USED. IT WAS REPORTED THE DEVICE FELL INTO PIECES DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14189911 ↗MalfunctionAug 20, 2020Break; Break
IT WAS REPORTED TO GORE THAT WHEN USING GORE-TEX® SUTURE (CV-2, ITEM 2M25A) IT KEPT COMING APART FROM AN UNKNOWN AREA AFTER THE KNOT WAS TIED. IT WAS REPORTED THERE WAS 5 TOTAL IN THE BOX. TWO WILL BE CAPTURED IN THIS EVENT AND THE OTHER THREE ARE CAPTURED IN (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10434820 ↗MalfunctionAug 20, 2020Break; Break
IT WAS REPORTED TO GORE THAT WHEN USING GORE-TEX® SUTURE (CV-2, ITEM 2M25A) IT KEPT COMING APART FROM AN UNKNOWN AREA AFTER THE KNOT WAS TIED. IT WAS REPORTED THERE WAS 5 TOTAL IN THE BOX.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10434695 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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