GORE-TEX Soft Tissue Patch 1310015020Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132600519), received between Jun 4, 2019 and Aug 16, 2023 — classified as 7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 16, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE FOLLOWING INFORMATION WAS OBTAINED FROM MEDICAL RECORDS. IMPLANT PROCEDURE: REPAIR OF GIANT VENTRAL HERNIA IN TRIFURCATION, LEFT AND RIGHT SUBCOSTAL REGIONS. IMPLANT: GORE-TEX® SOFT-TISSUE PATCH [1310015020/01294039, 15CM X 20CM X 2MM THICK]. IMPLANT DATE: (B)(6) 2007. EXPLANT PROCEDURE: REPAIR OF NON INCARCERATED RECURRENT VENTRAL INCISIONAL HERNIA, CLOSURE WITH 15 X 20 GORE-TEX MESH. IMPLANT #2: GORE-TEX® SOFT-TISSUE PATCH. [NO ALLEGATIONS OR ADVERSE EVENTS FOR THIS DEVICE, THEREFORE THIS PRODUCT IS NOT INCLUDED AS A COMPLAINT.] EXPLANT DATE: (B)(6) 2011. IMPLANT #1: 3736-1. ------------------------------------------------------------------ IT WAS INITIALLY REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL INCISIONAL HERNIA REPAIR ON (B)(6) 2007 WHEREBY A GORE-TEX® SOFT TISSUE PATCH WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2011, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: RECURRENCE, MESH DETACHMENT. EXPLANT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia

  MAUDE report 17556813 ↗
• InjuryApr 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC PARASTOMAL HERNIA REPAIR ON (B)(6) 2009 WHEREBY A GORE-TEX® SOFT TISSUE PATCH WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON SEPTEMBER 19, 2011 AND AUGUST 13, 2012, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION- DUE TO SEEDING FROM COLOSTOMY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 11755965 ↗
• InjuryMar 25, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2003 WHEREBY A GORE-TEX® SOFT TISSUE PATCH WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2012, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ABSCESS, INFECTION, AND EXPLANT. REMOVAL DUE TO LARGE INFECTION, ABSCESS, FLUID COLLECTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 11569993 ↗
• InjuryAug 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN CLOSURE OF GIANT OMPHALOCELE ON (B)(6) 2015 WHEREBY A GORE-TEX® SOFT TISSUE PATCH WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2016, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF INFECTED MESH, DEBRIDIMENT OF FASCIA. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 10393580 ↗
• InjuryMar 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN UMBILICAL HERNIA REPAIR ON (B)(6) 2012 WHEREBY A GORE-TEX® SOFT TISSUE PATCH 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: BOWEL OBSTRUCTION, EXTENSIVE LYSIS OF ADHESIONS, SURGERY TO REMOVE MESH, DILATED BOWEL, OMENTECTOMY, SEVERE AND CHRONIC PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Adhesion(s); No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion; Pain

  MAUDE report 9830965 ↗
• InjuryAug 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT AN OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2013 WHEREBY A GORE-TEX® SOFT TISSUE PATCH WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2016 AND (B)(6) 2016, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVAL (2X), ADDITIONAL SURGERIES, MESH FAILURE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 8891283 ↗
• InjuryJun 4, 2019Contamination; Insufficient Device Problem Information; Patient Device Interaction Problem; Contamination; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2013 WHEREBY A GORE DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2016, AN ADDITIONAL PROCEDURE WAS PERFORMED WHEREBY EXPLANT OF THE GORE DEVICE WAS PERFORMED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ABDOMINAL PAIN, INFECTED MESH, REVISION SURGERY, AND LOSS OF CONSORTIUM. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Erosion; No Code Available; Pain; Unspecified Infection

  MAUDE report 8665921 ↗