GORE BIO-A Tissue Reinforcement FS2020Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132605446), received between Aug 25, 2020 and Jul 16, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS OBTAINED FROM MEDICAL RECORDS. IMPLANT PROCEDURE: INCISIONAL HERNIA REPAIR WITH MESH. [IMPLANT: GORE® BIO-A® TISSUE REINFORCEMENT, FS2020/(B)(6), 20CM X 20CM] IMPLANT DATE: (B)(6) 2021 (HOSPITALIZATION DATES (B)(6) 2021). PARTIAL EXPLANT PROCEDURE: INCISION AND DRAINAGE OF SURGICAL SITE, WASHOUT, SMALL BOWEL REPAIR. PARTIAL EXPLANT DATE: (B)(6) 2021 HOSPITALIZATION DATES (B)(6) 2021) IMPLANT #1: (B)(6). IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2021 WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2022, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ON (B)(6) 2021 BUNCHING UP OR FOLDING OF THE MESH IN CENTER; DRAINAGE OF SURGICAL SITE, WASHOUT, AND SMALL BOWEL REPAIR. ON (B)(6) 2021 LAPAROTOMY, WASHOUT, REPAIR OF BOWEL PERFORATION, AND ABDOMINAL CLOSURE WITH LIFECELL STRATTICE MESH PLACEMENT. THERE WAS AN ENTERIC LEAK FROM A SMALL BOWEL PERFORATION. SURGEON FOUND THAT THE REPAIR FROM THE PREVIOUS OPERATION HAD FALLEN APART AS THE BOWEL WALL WAS VERY FRIABLE. THERE WAS A FASC

  Patient problems: Bowel Perforation

  MAUDE report 19750355 ↗
• InjuryJun 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT INCISIONAL HERNIA REPAIR ON (B)(6) 2012 WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2013, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION, ADHESIONS. HERNIA RECURRENCE, AND BOWEL REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Adhesion(s); Hernia; No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 12093950 ↗
• InjuryJun 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT INCISIONAL HERNIA REPAIR ON (B)(6) 2012 WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2013, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION, ADHESIONS. HERNIA RECURRENCE, AND BOWEL REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Adhesion(s); Hernia; No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 12093816 ↗
• InjuryAug 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL/ INCISIONAL HERNIA REPAIR ON (B)(6) 2012 WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2010 AND (B)(6) 2013, AN ADDITIONAL IMPLANT PROCEDURES OCCURRED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ENTEROCUTANEOUS FISTULAS, BOWEL REST, PARENTERAL NUTRITION WITH NO ALLOWANCES FOR EATING OR DRINKING, AND WOUND CARE, INCLUDING INTERVAL CONTRACTION OF THE WOUND USING A WOUND MANAGER SMALL BOWEL RESECTION, ILEOCOLECTOMY, REPAIR OF THE RECURRENT HERNIA, BILATERAL POSTERIOR RECTUS FASCIAL RELEASE, BILATERAL TRANSVERSALIS FASCIAL RELEASE, CLOSURE OF ABDOMINAL WALL DEFECT, AND COMPLEX ABDOMINAL WALL WOUND CLOSURE WITH TISSUE ADVANCEMENT FLAP. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 10448750 ↗