GORE BIO-A Tissue Reinforcement HH0710Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00733132606139), received between May 4, 2020 and Aug 30, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2013 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2014, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTED ABDOMINAL WALL MESH WITH RECURRENT HERNIA. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 17651426 ↗
• InjuryAug 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6), 2013 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6), 2014, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTED ABDOMINAL WALL MESH WITH RECURRENT HERNIA. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 17651403 ↗
• InjuryApr 14, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT HIATAL HERNIA REPAIR ON (B)(6) 2017 WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT 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: INFECTION, HERNIA RECURRENCE, MESH EROSION, OBSTRUCTION, VOMITING, AND SWELLING ABDOMEN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 11668199 ↗
• InjuryJan 26, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HIATAL HERNIA REPAIR ON (B)(6) 2010, (B)(6) 2017, AND (B)(6) 2017, WHEREBY GORE® DUALMESH® PLUS BIOMATERIAL AND GORE® BIO-A® TISSUE REINFORCEMENT WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2014, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY ONE OF THE GORE DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF GORE MESH DUE TO DENSE EROSION AND INFECTION, GORE MESH WAS STAINED THROUGHOUT DUE TO EROSION, FOUL SMELL FROM THE INFECTED GORE MESH, LARGE PORTION OF THE STOMACH ERODED TO THE GORE MESH, GASTRECTOMY DUE TO MESH EROSION, PORTION OF GORE MESH APPEARED DARK AND DISCOLORED, DENSE ADHESIONS NOTED ALONG THE UNDERSURFACE OF THE LIVER, PRIMARY REPAIR OF RECURRENT HIATAL HERNIA DEFECT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 11231914 ↗
• InjuryJul 31, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT HIATAL HERNIA REPAIR ON (B)(6) 2014 WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT 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: ORGAN PERFORATION, CHRONIC PAIN, ADHESION AND MESH EROSION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 10353759 ↗
• InjuryMay 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2014 WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2014, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: RECURRENT INCISIONAL HERNIA; REMOVAL OF MESH DUE TO MIGRATION AND WHICH WAS DENSELY ADHERED TO BOWEL LOOPS; PAIN & SUFFERING; GRANULATION TISSUE; DRAINING WOUNDS WITH TUBE INSERTIONS; CHRONIC INFECTION & INFLAMMATION; SEVERE PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 10021755 ↗