GORE BIO-A Tissue Reinforcement FS0915Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00733132605422), received between Jan 4, 2019 and Apr 19, 2023 — classified as 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 19, 2023Migration; Migration

  THE FOLLOWING INFORMATION WAS OBTAINED FROM MEDICAL RECORDS. IMPLANT #1 PROCEDURE: REPAIR OF INCISIONAL HERNIA WITH GORE BIO-A MESH, 10 X 15 CM PRODUCT WAS USED. [IMPLANT: GORE® BIO-A® TISSUE REINFORCEMENT, FS0915/(B)(4), 9CM X 15 CM]. IMPLANT #1 DATE: (B)(6) 2014 ((B)(6) 2014) IMPLANT #2 EXPLANT #1 PROCEDURE: INCISION OF OLD MESH FROM THE ABDOMINAL WALL WITH REPAIR OF INCISIONAL HERNIA WITH GORE-BIO A MESH. LYSES OF ADHESIONS REQUIRING 30 MINUTES OF OPERATIVE TIME. PERITONEAL LAVAGE WAS ALSO DONE. [IMPLANT: GORE® BIO-A® TISSUE REINFORCEMENT, FS2020/(B)(4), 20CM X 20 CM] . IMPLANT #2 EXPLANT #1 PROCEDURE DATE: (B)(6) 2014 (HOSPITALIZATION (B)(6) - (B)(6) 2014) EXPLANT #2 PROCEDURE: NO EVIDENCE THAT AN ADDITIONAL PROCEDURE OCCURRED RELATED TO THE GORE® BIO-A® TISSUE REINFORCEMENT, FS2020/(B)(4). IMPLANT #1: 3483-1. IMPLANT #2: 3483-2. ____________________________________________________________________________________________________________________ IT WAS INITIALLY REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2014 AND (B)(6) 2014 WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2014 AND (B)(6) 201

  Patient problems: Hernia

  MAUDE report 16769968 ↗
• InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE FIELD SALES ASSOCIATE THAT THE PHYSICIAN USED THE GORE® BIO-A® TISSUE REINFORCEMENT FOR A BREAST RECONSTRUCTION PROCEDURE. REPORTEDLY, THE PATIENT EXPERIENCED SEROMA AND INFECTION. IT WAS REPORTED THE PHYSICIAN REMOVED THE DEVICE DUE TO THE INFECTION. REPORTEDLY, THE PATIENT IS DOING WELL ACCORDING TO THE FOLLOW UPS. REPORTEDLY, THE DEVICE WAS EXPLANTED 3 WEEKS AFTER INTERVENTION AND WAS REMOVED VIA SKIN INCISION. IT WAS REPORTED THE INFECTION WAS TREATED WITH ANTIBIOTICS AND THE MESH WAS REMOVED. REPORTEDLY, THERE WAS A WOUND DEHISCENCE AND THERE WERE DRAINS PLACED DURING THE PROCEDURE. IT WAS REPORTED THE SEROMA WAS ASPIRATED. DRAINED AND THE DEVICE WAS PLACED NEXT TO WELL VASCULARIZED TISSUE ON BOTH SIDES.

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 14680788 ↗
• InjuryJun 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE FIELD SALES ASSOCIATE THAT THE PHYSICIAN USED THE GORE® BIO-A® TISSUE REINFORCEMENT FOR A BREAST RECONSTRUCTION PROCEDURE. REPORTEDLY, THE PATIENT EXPERIENCED SEROMA AND INFECTION. IT WAS REPORTED THE PHYSICIAN REMOVED THE DEVICE DUE TO THE INFECTION. REPORTEDLY, THE PATIENT IS DOING WELL ACCORDING TO THE FOLLOW UPS. REPORTEDLY, THE DEVICE WAS EXPLANTED 3 WEEKS AFTER INTERVENTION AND WAS REMOVED VIA SKIN INCISION. IT WAS REPORTED THE INFECTION WAS TREATED WITH ANTIBIOTICS AND THE MESH WAS REMOVED. REPORTEDLY, THERE WAS A WOUND DEHISCENCE AND THERE WERE DRAINS PLACED DURING THE PROCEDURE. IT WAS REPORTED THE SEROMA WAS ASPIRATED. DRAINED AND THE DEVICE WAS PLACED NEXT TO WELL VASCULARIZED TISSUE ON BOTH SIDES.

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 14680195 ↗
• InjurySep 22, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2012 WHEREBY A GORE¿ DUALMESH¿ PLUS BIOMATERIAL WAS IMPLANTED AND ON (B)(6) 2013 WHEREBY A GORE¿ BIO-A¿ TISSUE REINFORCEMENT WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2013 AND (B)(6) 2018, ADDITIONAL PROCEDURES OCCURRED WHEREBY A GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION, RECURRENCE, REMOVAL OF MESH, ABSCESSES, SEVERE AND CHRONIC PAIN/DISCOMFORT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 12513041 ↗
• InjuryJan 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC HIATAL HERNIA REPAIR ON (B)(6) 2013 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: ADHESIONS, INFLAMMATION, PARTIAL REMOVAL OF SURGICAL MESH, WEIGHT LOSS, SEVERE AND CHRONIC PAIN/DISCOMFORT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Dysphagia/ Odynophagia; Foreign Body Reaction; Inflammation

  MAUDE report 11239819 ↗
• InjuryJan 14, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2017 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: REMOVAL OF TORN GORE MESH, PREVIOUS GORE MESH WAS FOUND SEVERELY DEGRADED AND HAD ZERO STRENGTH, PRIMARY REPAIR OF RECURRENT INCARCERATED VENTRAL HERNIA DEFECT, ADHESIONS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 11171595 ↗
• InjuryMay 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2008 WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2010, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: EXTENSIVE ADHESIONS, ENTEROCUTANEOUS FISTULA, INFECTION, FOREIGN BODY REACTION, CHRONIC INFLAMMATION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 10030942 ↗
• InjuryMar 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT INCISIONAL HERNIA REPAIR ON (B)(6) 2017 WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2018, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH MIGRATION, INFECTION, CHRONIC PAIN, AND HERNIA RECURRENCE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia; Insufficient Information; No Clinical Signs, Symptoms or Conditions; Pain; Unspecified Infection

  MAUDE report 9871293 ↗
• InjuryNov 4, 2019Insufficient 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® TISSUE REINFORCEMENT WAS 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. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 9271253 ↗
• InjuryMay 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC PARASTOMAL HERNIA REPAIR ON (B)(6) 2013, WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT AND A GORE® DUALMESH® PLUS BIOMATERIAL WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2014, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADHESIONS, SURGERY TO REMOVE MESH, ADHESIONS TO THE BOWEL, SCARRING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Adhesion(s); No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 8569937 ↗
• InjuryApr 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2009 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL AND A GORE® BIO-A® TISSUE REINFORCEMENT WERE IMPLANTED. THE FOLLOWING WAS REPORTED: ¿ON (B)(6) 2011 THE PATIENT BEGAN A LENGTHY HOSPITALIZATION FOR INFECTED MESH WITH SEROMA. ON (B)(6) 2011, A CT GUIDED ASPIRATION WAS PERFORMED. REMOVAL AND REPLACEMENT OF THE MESH WAS THEN PERFORMED ON (B)(6) 2011. THE MESH WAS NOTED TO BE SURROUNDED WITH FLUID AND A PEEL. THE MESH HAD ALSO BECOME DEFORMED AND WAS NOT ATTACHED IN SEVERAL LOCATIONS.¿ IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING PRODUCT DEFICIENCIES: STRICT PRODUCTS LIABILITY, NEGLIGENCE, IMPLIED AND ESPRESS WARRANTY, FRAUD, FRAUDULENT CONCEALMENT, PUNITIVE DAMAGES. ADDITIONAL EVENT SPECIFIC INFORMATION AND MEDICAL RECORDS HAVE BEEN REQUESTED.

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

  MAUDE report 8558277 ↗
• InjuryJan 4, 2019No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2013, WHEREBY A GORE DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2013, AN ADDITIONAL PROCEDURE WAS PERFORMED WHEREBY EXPLANT OF THE GORE DEVICE WAS PERFORMED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERY, INFECTION, ABDOMINAL PAIN, DEBRIDEMENT OF WOUND, REMOVAL OF MESH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Not Applicable; Unspecified Infection

  MAUDE report 8216788 ↗