GORE BIO-A Tissue Reinforcement FS2030Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00733132605453), received between May 10, 2019 and Apr 20, 2023 — classified as 9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2023Use of Device Problem; Migration; Use of Device Problem; Migration

  THE FOLLOWING INFORMATION WAS OBTAINED FROM MEDICAL RECORDS. IMPLANT #1 PROCEDURE: EXPLORATORY LAPAROTOMY, ADHESIOLYSIS FOR 120 MINUTES, SEGMENTAL SMALL BOWEL RESECTION WITH PRIMARY ENTEROENTEROSTOMY, AND COMPLEX CLOSURE OF ABDOMINAL WALL WITH BIOLOGIC MESH 20CM X 30CM. IMPLANT: GORE® BIO-A® TISSUE REINFORCEMENT, FS2030/(B)(4), 20CM X 30 CM]. IMPLANT #1 DATE: (B)(6) 2015 (HOSPITALIZATION (B)(6) 2015). REVISION #1 PROCEDURE: REOPENING RECENT LAPAROTOMY WITH REPAIR OF FASCIAL DEHISCENCE, PLACEMENT OF VICRYL MESH OVERLAY, AND NEGATIVE PRESSURE THERAPY DRESSING 30CM X 15CM. REVISION #1 DATE: (B)(6) 2015. EXPLANT #1 PROCEDURE: EXPLORATORY LAPAROTOMY, SMALL BOWEL RESECTION X2 WITH PRIMARY ANASTOMOSIS, ABTHERA WOUND VAC NEGATIVE PRESSURE DRESSING PLACEMENT. EXPLANT #1 DATE: (B)(6) 2016 [HOSPITALIZATION (B)(6) 2016]. IMPLANT #2 AND #3 PROCEDURE: REOPENING OF RECENT LAPAROTOMY, ABDOMINAL WASHOUT, DEBRIDEMENT OF ABDOMINAL WALL (EXCISION OF SKIN MEASURING APPROX. 50 SQ. CM, PLACEMENT OF TWO 20X30 CM GORE DUAL MESH PLUS TO SKIN FOR SALVAGE ABDOMINAL CLOSURE. [IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL PLUS X2, 1DLMCP203/(B)(4), 20CM X 30CM X 2MM THICK AND 1DLMCP203/(B)(4), 20CM X 30CM X 2MM THI

  Patient problems: Hernia

  MAUDE report 16775863 ↗
• InjuryMar 28, 2023Contamination; Contamination

  THE FOLLOWING INFORMATION WAS OBTAINED FROM MEDICAL RECORDS. IMPLANT#: 1 PROCEDURE: LAPAROSCOPIC REPAIR OF VENTRAL HERNIA WITH POLYTETRAFLUOROETHYLENE SOFT TISSUE PATCH. [IMPLANT GORE® DUALMESH® PLUS BIOMATERIAL, 1DLMCP08/05729033, 26CM X 34CM X 1MM THICK, OVAL]. IMPLANT#: 1 DATE: ON (B)(6) 2008 [HOSPITALIZATION DATES ON (B)(6) 2008]. IMPLANT#: 2 AND EXPLANT#: 1 PROCEDURE: OPEN RECURRENT INCISIONAL HERNIA REPAIR. REMOVAL OF PROSTHETIC MESH. IMPLANTATION OF MESH. ENTEROLYSIS. DEBRIDEMENT OF MUSCLE AND FASCIA, FIRST 20 SQ CM. DEBRIDEMENT OF MUSCLE AND FASCIA, ADDITIONAL 20 SQ CM. INCISIONAL NEGATIVE PRESSURE WOUND THERAPY. [IMPLANT: GORE® BIO-A® TISSUE REINFORCEMENT, FS2030/14969704, 20CM X 30CM]. IMPLANT#: 2 AND EXPLANT#: 1 DATE: ON (B)(6) 2016 [HOSPITALIZATION DATES NOT PROVIDED]. IMPLANT#: 3 [NO ALLEGATIONS] AND EXPLANT#: 2 PROCEDURE: OPEN RECURRENT INCISIONAL HERNIA REPAIR. END JEJUNOSTOMY. REMOVAL OF PROSTHETIC MESH. IMPLANTATION OF MESH. [IMPLANT: GORE® BIO-A® TISSUE REINFORCEMENT, FS2030/15116434, 20CM X 30CM.]. IMPLANT#: 3 AND EXPLANT#: 2 DATE: ON (B)(6) 2016 [HOSPITALIZATION DATES NOT PROVIDED]. IMPLANT#: 1: 2409-1. IMPLANT#: 2: 2409-2. IT WAS INITIALLY REPORTED TO GORE THAT

  Patient problems: Erosion; Fistula

  MAUDE report 16627555 ↗
• InjuryJul 27, 2021Off-Label Use; Improper or Incorrect Procedure or Method; Microbial Contamination of Device; Off-Label Use; Improper or Incorrect Procedure or Method; Microbial Contamination of Device

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCARCERATED VENTRAL HERNIA REPAIR ON (B)(6) 2020, WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2021, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADHESIONS, SURGERY TO REMOVE MESH, BOWEL RESECTION, WOUND VAC, SEVERE AND CHRONIC PAIN/DISCOMFORT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12233994 ↗
• InjuryJun 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT UMBILICAL 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: INFECTION, CHRONIC PAIN, HERNIA RECURRENCE, AND SWELLING ABDOMEN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 12093622 ↗
• InjuryAug 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) 2014 WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT WAS IMPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTED MESH, SEROMA, ABDONIMAL PAIN, NAUSEA, VOMITING, WOUND VAC, ADDITIONAL SURGICAL PROCEDURE TO REMOVE NECROTIC SKIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 10381988 ↗
• InjuryNov 26, 2019Material Separation; Material Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019 A SURGEON IMPLANTED A GORE® BIO-A® TISSUE REINFORCEMENT IN CLEAN FIELD VENTRAL HERNIA REPAIR USING RIVES TECHNIQUE. IT WAS REPORTED THE PATIENT HAD A RECURRENCE ON (B)(6) 2019. ON (B)(6) 2019 THE SURGEON RE-OPERATED ON THE PATIENT AND FOUND THAT THE DEVICE WAS BROKEN IN SMALL PIECES. THE DEVICE WAS REMOVED. A PP MESH WAS PLACED AND IN TWO DAYS THE PATIENT WAS SENT HOME IN GOOD CONDITION. IT WAS FURTHER REPORTED THE DEFECT SIZE WAS 3X4 CMS ON THE MIDLINE SUVRA UMBILICAL AT THE EXTRACTION SITE AFTER ROBOTIC PROSTATECTOMY. REPORTEDLY, THE DEVICE WAS PLACED RETRORECTUS SUBLAY AND WAS TRIMMED ON 4 CORNERS WITHOUT REDUCING SIZE. ADDITIONALLY, VYCRIL 1/0 WAS USED TO CLOSE THE DEFECT IN THE POSTERIOR FASCIA. PROLENE 2/0 WAS USED AT THE FOUR CORNERS.

  Patient problems: Hernia

  MAUDE report 9378211 ↗
• InjuryJun 1, 2019Material Separation; Material Separation

  IT WAS REPORTED TO GORE THAT A PHYSICIAN WAS CONCERNED THAT AFTER ONE WEEK POST IMPLANT OF A GORE® BIO-A® TISSUE REINFORCEMENT (ITEM: FS2030) IT WAS NOT INTEGRATING CORRECTLY AND TEARING WHILE IN SITU. THE GORE® BIO-A® TISSUE REINFORCEMENT WAS IMPLANTED IN A PATIENT WHO HAD PRONOUNCED LOSS OF ABDOMEN. THE PHYSICIAN COULD NOT GET CLOSURE AND PLACED THE GORE® BIO-A® TISSUE REINFORCEMENT IN THE RETRO RECTUS PLANE. THE PHYSICIAN DECIDED TO EXPLANT THE MATERIAL DUE TO IT TEARING, AND IT HAS BEEN SAVED TO BE SENT BACK TO GORE FOR EVALUATION.

  Patient problems: Hernia

  MAUDE report 8661179 ↗
• InjuryMay 10, 2019Patient-Device Incompatibility

  THE PATIENT WAS IMPLANTED WITH TWO GORE® BIO-A® TISSUE REINFORCEMENTS ON (B)(6) 2016. IT WAS STATED THAT THE PATIENT RECEIVED A VACUUM THERAPY AND AN ¿ABDOMINAL WASHING¿ PRIOR DEVICE IMPLANTATION. IT WAS STATED THAT THE TWO DEVICES WERE IMPLANTED WITH DIRECT CONTACT OF THE BOWEL FOLLOWED BY A COLOSTOMY AND VACUUM THERAPY. ON (B)(6) 2019, THE TWO GORE® BIO-A® TISSUE REINFORCEMENTS WERE EXPLANTED AS IT WAS STATED THAT PIECES FROM THE MATERIAL WERE REJECTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8601456 ↗
• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH TWO GORE® BIO-A® TISSUE REINFORCEMENTS ON (B)(6) 2016. IT WAS STATED THAT THE PATIENT RECEIVED A VACUUM THERAPY AND AN ¿ABDOMINAL WASHING¿ PRIOR DEVICE IMPLANTATION. IT WAS STATED THAT THE TWO DEVICES WERE IMPLANTED WITH DIRECT CONTACT OF THE BOWEL FOLLOWED BY A COLOSTOMY AND VACUUM THERAPY. ON (B)(6) 2019, THE TWO GORE® BIO-A® TISSUE REINFORCEMENTS WERE EXPLANTED AS IT WAS STATED THAT PIECES FROM THE MATERIAL WERE REJECTED.

  Patient problems: No Code Available

  MAUDE report 8601445 ↗