GORE-TEX Soft Tissue Patch 1320030020Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132600533), received between Aug 11, 2020 and May 27, 2021 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryMay 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2010 AND (B)(6) 2011 WHEREBY A GORE-TEX® SOFT TISSUE PATCH 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: INFECTION [MULTIPLE SEEDINGS], EXPLANT "3 GORE DEVICES. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 11898870 ↗
• InjuryMar 24, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN DIAPHRAGMATIC HERNIA REPAIR ON (B)(6) 2014 WHEREBY A GORE-TEX® SOFT TISSUE PATCH 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: HERNIA RECURRENCE, INFECTED MESH, BOWEL PERFORATION, MESH MIGRATION, ABSCESS, MESH EROSION, REMOVAL OF INFECTED MESH AND ADHESIONS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia; Unspecified Infection

  MAUDE report 11564188 ↗
• InjuryMar 24, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN DIAPHRAGMATIC HERNIA REPAIR ON (B)(6) 2014 WHEREBY A GORE-TEX® SOFT TISSUE PATCH 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: HERNIA RECURRENCE, INFECTED MESH, BOWEL PERFORATION, MESH MIGRATION, ABSCESS, MESH EROSION, REMOVAL OF INFECTED MESH AND ADHESIONS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Erosion; Hernia; Perforation; Unspecified Infection

  MAUDE report 11564140 ↗
• InjuryAug 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2009 WHEREBY A GORE-TEX® SOFT TISSUE PATCH, AND ON (B)(6) 2013 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2013, (B)(6) 2013, (B)(6) 2015 AND (B)(6) 2016 ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICES WERE EXPLANTED OR PARTIALLY EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: FOR THE GORE-TEX® SOFT TISSUE PATCH; REMOVAL OF INFECTED MESH; RECURRENT INCISIONAL HERNIA; ABSCESS; CHRONIC INFECTION & INFLAMMATION; LYSIS OF ADHESION'S; SEVERE PAIN, THERE WAS A RECURRENT DEFECT BELOW THE GORE MESH. FOR THE GORE® DUALMESH® BIOMATERIAL; ((B)(6) 2015) EXCISION OF ELLIPTICAL SKIN AND SUBCUTANEOUS TISSUE AND SINUS TRACT OF THE ABSCESS, DRAINAGE OF ABDOMINAL WALL AND INTRA-ABDOMINAL ABSCESS AND PARTIAL MESH EXCISION, ((B)(6) 2016) REMOVAL OF INFECTED MESH, INCISIONAL HERNIA REPAIR, LYSIS OF ADHESION'S, LAPAROTOMY DUE TO INFECTED MESH, ABSCESS, DRAINAGE OF SINUS TRACT AND ABSCESS CAVITY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10393505 ↗