GORE-TEX Suture 4U16Recalls & reported problems
W. L. Gore & Associates, Inc. · GORE-TEX SUTURE CV-4 122cm DoubleArm PH-24-1dz · Class 2 · Implant
All models of GORE-TEX Suture (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132628995), received between Jan 27, 2021 and Jan 28, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Break” (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
Device problems
- Break2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 28, 2021Break; Break
IT WAS REPORTED TO GORE BY THE PRODUCT SPECIALIST THAT ON (B)(6) 2020 A BREAST REDUCTION MAMMAPLASTY AND AREOLA RECONSTRUCTION WAS PERFORMED ON THE BREAST USING THE 4U16A GORE-TEX® SUTURE. THE NEEDLES WERE REMOVED AND THE SUTURE WAS ATTACHED TO A KEITH NEEDLE FOR THE PROCEDURE. ON (B)(6) 2021 THE PHYSICIAN OBSERVED THAT THE SUTURE HAD BROKEN. IT WAS REPORTED THE PATIENT WILL RETURN FOR A RE-OPERATION, BUT A DATE HAS NOT BEEN SCHEDULED YET.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11247655 ↗InjuryJan 27, 2021Break; Break
IT WAS REPORTED TO GORE BY THE PRODUCT SPECIALIST THAT ON MAY 15TH, 2019 A 4U16A GORE-TEX® SUTURE WAS USED FOR A BREAST REDUCTION MAMMAPLASTY AND AREOLA RECONSTRUCTION. THE NEEDLES WERE REMOVED AND THE SUTURE WAS ATTACHED TO A KEITH NEEDLE FOR THE PROCEDURE. ON (B)(6) 2019 THE PHYSICIAN OBSERVED THAT THE SUTURE HAD BROKEN. ON (B)(6) 2020 A RE-OPERATION WAS PERFORMED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11241443 ↗
Other SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE devices
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- PROLENE 8556HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death240 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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