GORE-TEX SutureRecalls & reported problems across all models
W. L. Gore & Associates, Inc. · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 19 models of GORE-TEX Suture by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Dec 12, 2018 and Jan 16, 2026 — classified as 6 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Break” (21 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 problems
Device problems
- Break21
- Material Frayed6
- Material Separation4
- Fracture2
- Loss of or Failure to Bond2
- Degraded1
- Detachment of Device or Device Component1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Known Impact Or Consequence To Patient8
- No Consequences Or Impact To Patient7
- Insufficient Information3
- Mitral Valve Insufficiency/ Regurgitation2
- Wound Dehiscence2
- Fluid Discharge1
- Foreign Body In Patient1
GORE-TEX Suture models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GORE-TEX Suture 2M25SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE4 reports
- GORE-TEX Suture 6M02SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 reports
- GORE-TEX Suture 6M04SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 reports
- GORE-TEX Suture 7M04SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 reports
- GORE-TEX Suture 2U17SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 reports
- GORE-TEX Suture 3200SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 reports
- GORE-TEX Suture 3N07SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 reports
- GORE-TEX Suture 4U06SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 reports
- GORE-TEX Suture 4U16SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 reports
- GORE-TEX Suture 7K04SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 reports
- GORE-TEX Suture 0N05SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- GORE-TEX Suture 3N08SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- GORE-TEX Suture 4N02SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- GORE-TEX Suture 6J04SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- GORE-TEX Suture 6K02SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- GORE-TEX Suture 7M02SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- GORE-TEX Suture 7M06SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- GORE-TEX Suture 8K08SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
- GORE-TEX Suture 8K10SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 report
Recent GORE-TEX Suture adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2026Break; Material Frayed
IT WAS REPORTED TO GORE THAT ON (B)(6) 2025, A PATIENT WAS TO BE IMPLANTED WITH GORE-TEX® SUTURE TO PERFORM ARTERIOVENOUS FISTULA. TWO SUTURES WERE FORKED. ONE SUTURE WAS BROKEN DURING THE KNOTTING. THEREFORE, NEW SUTURE WAS UTILIZED. THE PROCEDURE WAS PROLONGED AND COMPLETED WITHOUT ADVERSE EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24091476 ↗MalfunctionJan 15, 2026Break; Material Frayed
IT WAS REPORTED TO GORE THAT ON (B)(6) 2025, A PATIENT WAS TO BE IMPLANTED WITH GORE-TEX® SUTURE TO PERFORM AUTOLOGOUS VASCULAR SURGERY. ONE SUTURE WAS FORKED. THE OTHER ONE WAS BROKEN DURING THE KNOTTING. TOTALLY TWO SUTURES WERE BROKEN. THE PROCEDURE WAS COMPLETED WITH NEW SUTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24090476 ↗InjuryNov 19, 2025Degraded; Stretched; Degraded; Stretched
IT WAS REPORTED THAT THE PATIENT UNDERWENT MITRAL VALVE REPAIR SURGERY USING GORE-TEX® SUTURE (4N02A) FOR TENDON REPAIR ON (B)(6) 2025. AFTER THE SURGERY, IT WAS FOUND THAT THE MITRAL REGURGITATION HAD WORSENED, SO AN REINTERVENTION WAS PERFORMED ON THE SAME DAY. IT WAS OBSERVED THAT THE SUTURE THREAD 1.5 CM LONGER THAN ORIGINAL USED VISUALLY AFTER IT WAS REMOVED FROM PATIENT. THERE WAS NO SUTURE FRAY NOR BREAK OBSERVED. ANOTHER 4N02A SUTURE OF SAME LOT WAS TAKEN FOR IN VITRO TESTING, AND IT WAS FOUND THAT THE SUTURE COULD BE ELONGATED AND THERE WAS NO SUTURE FRAY NOR BREAK OBSERVED. THEREFORE, CV-5 SUTURE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. PATIENT TOLERATED THE PROCEDURE AND POSTOPERATIVE EXAMINATION WAS WELL.
Patient problems: Mitral Valve Insufficiency/ Regurgitation
MAUDE report 23601189 ↗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 ↗MalfunctionNov 25, 2024Break; Material Separation; Break; Material Separation
IT WAS REPORTED TO GORE THAT A GORE-TEX® SUTURE BROKE DURING A PROCEDURE. IT BROKE INSIDE A PATIENT DURING AN ONGOING SUTURING OF AN ANASTOMOSIS IN A NON-CALCIFIED VESSEL. THE PATIENT STATUS IS NOT DISCLOSED.
Patient problems: Insufficient Information
MAUDE report 20771464 ↗MalfunctionAug 14, 2024Fracture; Fracture
IT WAS REPORTED TO GORE THAT ON (B)(6) 2024, A PATIENT WAS TO BE USED WITH GORE-TEX® SUTURE (6M02A)) DURING PROCEDURE. THE SUTURE AIMED TO SUTURE VASCULAR GRAFT (GORE, RRT08070070L). BUT THE SUTURE WAS BROKEN IMMEDIATELY WHEN PHYSICIAN WAS ATTEMPTING TO SLIP THE KNOB AFTER PUNCTURING THE VASCULAR GRAFT. ANOTHER SUTURE OF SAME MODEL WAS USED TO SUCCESSFULLY COMPLETE THE SURGERY. THE PATIENT'S CONDITION REMAINED STABLE AFTER SURGERY WITHOUT ANY ADVERSE REACTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19979086 ↗MalfunctionJun 5, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED TO GORE THAT A GORE-TEX® SUTURE FOR CHORDAE TENDINEAE (4 DEVICES) BROKE DURING TYING OF THE KNOT DURING A TRICUSPID VALVE ANNULOPLASTY. THERE HAS BEEN NO CONSEQUENCES FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19467227 ↗MalfunctionMay 21, 2024Premature Separation; Premature Separation
THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, IT WAS FOUND THAT SUTURE WAS SPLIT DURING SUTURING. IT WAS UNABLE TO USE. ANOTHER NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19356712 ↗MalfunctionMar 25, 2024Material Frayed; Material Frayed
IT WAS REPORTED THE PHYSICIAN USED THE GORE-TEX® SUTURE. REPORTEDLY, THE FIRST SUTURE START FRAYING, THEN A SECOND SUTURE WAS USED AND IT START FRAYING AS WELL. IT WAS REPORTED THE 3RD SUTURE USED WORKED FINE. REPORTEDLY, THE PROCEDURE BEING PERFORMED WAS AUGMENTATION-MASTOPEXY. IT WAS REPORTED, THE SURGEON THOUGHT BECAUSE THE FRAY WAS AT THE END OF THE SUTURE THE PROXIMAL PORTION WOULD BE OK. IT SUBSEQUENTLY FRAYED IN THE PATIENTS BODY. REPORTEDLY, A DEHISCENCE ALONG THE SURGICAL INCISION OCCURRED, BUT WAS REPAIRED WITH ADDITIONAL SUTURES.
Patient problems: Wound Dehiscence
MAUDE report 18975214 ↗MalfunctionMar 25, 2024Material Frayed; Material Frayed
IT WAS REPORTED THE PHYSICIAN USED THE GORE-TEX® SUTURE. REPORTEDLY, THE FIRST SUTURE START FRAYING, THEN A SECOND SUTURE WAS USED AND IT START FRAYING AS WELL. IT WAS REPORTED THE 3RD SUTURE USED WORKED FINE. REPORTEDLY, THE PROCEDURE BEING PERFORMED WAS AUGMENTATION-MASTOPEXY. IT WAS REPORTED, THE SURGEON THOUGHT BECAUSE THE FRAY WAS AT THE END OF THE SUTURE THE PROXIMAL PORTION WOULD BE OK. IT SUBSEQUENTLY FRAYED IN THE PATIENTS BODY. REPORTEDLY, A DEHISCENCE ALONG THE SURGICAL INCISION OCCURRED, BUT WAS REPAIRED WITH ADDITIONAL SUTURES.
Patient problems: Wound Dehiscence
MAUDE report 18974391 ↗MalfunctionNov 20, 2023Break; Fracture; Break; Fracture
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT A GRAFT ANASTOMOSIS USING GORE-TEX® SUTURE. IT WAS STATED THAT 11 UNITS FROM THE BOX WERE BREAKING DURING THE INTERVENTION. THE INTERVENTION WAS COMPLETED BY USING IDENTICAL GORE-TEX® SUTURES. THE TORN DEVICES ARE AVAILABLE FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18168438 ↗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 ↗MalfunctionNov 14, 2023Break; Break
IT WAS REPORTED THAT WHENEVER THE SURGEON TRIED TO TIE THE GORE-TEX® SUTURE, IT WOULD BREAK. REPORTEDLY, A TOTAL OF 8 OUT OF THE 36 IN THE BOX WAS DISCARDED. MULTIPLE ATTEMPTS WERE MADE TO GET ADDITIONAL INFORMATION, HOWEVER NO RESPONSE FROM THE COMPLAINANT WAS RECEIVED, THE CASE WILL BE CLOSED WITH THE REPORTED INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18136483 ↗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 ↗MalfunctionJul 28, 2023Unraveled Material; Unraveled Material
IT WAS REPORTED BY THE CUSTOMER THAT WHEN THE DOCTOR TRIED TO USE GORE-TEX® SUTURE, IT BEGAN UNRAVELING ON HIM. REPORTEDLY, HE PUT ABOUT 10 KNOTS IN THE SUTURE AND IT CONTINUED TO UNRAVEL. IT WAS REPORTED A NEW BOX WAS OPENED AND THE SUTURES UNRAVELED ON THE DOCTOR AGAIN WHEN ATTEMPTING TO USE THEM ON THE PATIENT. REPORTEDLY, THE DOCTOR TOOK THEM ALL OUT AND RE-SUTURED THE PATIENT. THE COMPLAINANT ((B)(6)) CONFIRMED THE UNRAVELLING OCCURRED DURING THE PROCEDURE. SHE WAS NOT ABLE TO CONFIRM ANY ADDITIONAL DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17420147 ↗
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 16, 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