GORE BIO-A Hernia Plug HP02Recalls & reported problems
W. L. Gore & Associates, Inc. · GORE BIOABSORB HERNIA PLUG 1PK · Class 2 · Implant
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 00733132606153), received between Nov 4, 2019 and Sep 5, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
Patient problems
- Hernia2
- No Clinical Signs, Symptoms or Conditions2
- Adhesion(s)1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT AN UNKNOWN HERNIA REPAIR ON (B)(6), 2016, WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT WAS IMPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: LAPAROSCOPIC REPAIR INCARCERATED HERNIA REPAIR, DIFFICULT DISSECTION DUE TO PRIOR REPAIR, SCAR TISSUE AND PERMANENT SUTURES. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Hernia; No Clinical Signs, Symptoms or Conditions
MAUDE report 22977261 ↗InjuryNov 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INGUINAL HERNIA REPAIR ON (B)(6) 2014 WHEREBY A GORE® BIO-A® HERNIA PLUG AND GORE® BIO-A® TISSUE REINFORCEMENT WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2015 AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: RECURRENCE NECESSITATING REVISION, DEGRADATION OF MESH, ADHESIONS, PAIN, ETC. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Adhesion(s); Hernia; No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 9271340 ↗
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- NEOVEIL NV-ET-M60A-2Gunze Limited · Mesh, Surgical, Absorbable, Staple Line Reinforcement1 report
- GORE BIO-A Tissue Reinforcement FS1030W. L. Gore & Associates, Inc. · Mesh, surgical, absorbable, staple line reinforcement1 report
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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