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GORE BIO-A Hernia Plug HP01Recalls & reported problems

W. L. Gore & Associates, Inc. · GORE BIOABSORB HERNIA PLUG 2PK · Class 2 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132606146), received between May 7, 2020 and Sep 3, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Insufficient Device Problem Information3

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • Fistula2
  • Unspecified Infection2
  • No Code Available1
  • Obstruction/Occlusion1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjurySep 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2014 WHEREBY A GORE® BIO-A® HERNIA PLUG WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2019, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF PREVIOUS GORE MESH DUE TO EROSION TO THE COLON, SMALL BOWEL RESECTION DUE TO DENSE EROSION, GORE MESH WAS NOT INCORPORATED, INFECTION, EXTENSIVE ADHESIONS FROM MESH TO COLON FISTULA. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

    Patient problems: Fistula; No Clinical Signs, Symptoms or Conditions; Unspecified Infection

    MAUDE report 10489219 ↗
  • InjuryAug 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INGUINAL HERNIA REPAIR ON (B)(6) 2013 WHEREBY A GORE® BIO-A® HERNIA PLUG WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2017, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: PAIN, MESH BROKE APART AND ATTACHED TO THE STOMACH WALL AND INTESTINES, MESH REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

    MAUDE report 10385924 ↗
  • InjuryMay 7, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2015 WHEREBY A GORE® BIO-A® HERNIA PLUG WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2016, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: "CHRONIC GRANULATING WOUND; ENTEROCUTANEOUS FISTULA; REMOVAL OF INFECTED MESH; SUTURES, AND GRANULATION TISSUE; SMALL-BOWEL OBSTRUCTION DUE TO ADHESIONS." ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

    Patient problems: Fistula; No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion; Unspecified Infection

    MAUDE report 10032508 ↗

Other Mesh, surgical, absorbable, abdominal hernia devices

All Mesh, surgical, absorbable, abdominal hernia devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.