GORE-TEX Suture Oral Health P7K13Recalls & reported problems
W. L. Gore & Associates, Inc. · GORE-TEX SUTURE CV-7 61cm RT-11-1dz · Class 2 · Implant
All models of GORE-TEX Suture Oral Health (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132628490), received between Aug 15, 2018 and Aug 15, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Separation Problem” (3 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
Device problems
- Separation Problem3
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 15, 2018Separation Problem; Separation Problem
IT WAS REPORTED TO GORE THAT DURING A CONNECTIVE TISSUE GRAFT PROCEDURE USING GORE-TEX® SUTURE, ITEM# P7K13A/15829623A, THE SUTURE BROKE AS THE SUTURE WAS BEING PULLED THROUGH THE GUM. IT WAS REPORTED THE THREAD BROKE NEAR THE END OF SUTURING AND THE REMAINING PIECE OF SUTURE WAS CUT OFF AND DISCARDED. IT WAS REPORTED THAT A DIFFERENT LOT OF SUTURE WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7785258 ↗MalfunctionAug 15, 2018Separation Problem; Separation Problem
IT WAS REPORTED TO GORE THAT DURING A CONNECTIVE TISSUE GRAFT PROCEDURE USING GORE-TEX® SUTURE, ITEM# P7K13A/15829623A, TWO SUTURES BROKE AS THE SUTURE WAS BEING PULLED THROUGH THE GUM. IT WAS REPORTED THE THREAD BROKE NEAR THE END OF SUTURING AND THE REMAINING PIECE OF SUTURE WAS CUT OFF AND DISCARDED. IT WAS REPORTED THAT A DIFFERENT LOT OF SUTURES WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7785204 ↗MalfunctionAug 15, 2018Separation Problem; Separation Problem
IT WAS REPORTED TO GORE THAT DURING A CONNECTIVE TISSUE GRAFT PROCEDURE USING GORE-TEX® SUTURE, ITEM# P7K13A/15829623A, TWO SUTURES BROKE AS THE SUTURE WAS BEING PULLED THROUGH THE GUM. IT WAS REPORTED THE THREAD BROKE NEAR THE END OF SUTURING AND THE REMAINING PIECE OF SUTURE WAS CUT OFF AND DISCARDED. IT WAS REPORTED THAT A DIFFERENT LOT OF SUTURES WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7785194 ↗
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE devices
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- PROLENE 8805HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death209 reports
- PROLENE 8521HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 deaths183 reports
- PROLENE 8735HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE163 reports
- PROLENE 8711HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall89 reports
- PROLENE 9702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE130 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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