GORE-TEX Soft Tissue PatchRecalls & reported problems across all models
W. L. Gore & Associates, Inc. · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 52
- Deaths reported
- 0
- Injuries reported
- 52
- Recalls
- 0
We found 10 models of GORE-TEX Soft Tissue Patch by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 52 adverse event reports in the FDA's MAUDE database, received between Jun 27, 2018 and Nov 7, 2023 — classified as 52 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (51 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported GORE-TEX Soft Tissue Patch problems
Device problems
- Insufficient Device Problem Information51
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Contamination1
- Deformation Due to Compressive Stress1
- No Apparent Adverse Event1
- Patient Device Interaction Problem1
Patient problems
- Unspecified Infection29
- No Clinical Signs, Symptoms or Conditions24
- No Code Available14
- Hernia13
- Erosion8
- Abscess7
- Adhesion(s)6
- Obstruction/Occlusion5
GORE-TEX Soft Tissue Patch models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GORE-TEX Soft Tissue Patch 1315020020Mesh, Surgical, Polymeric12 reports
- GORE-TEX Soft Tissue Patch 1410015010Mesh, Surgical, Polymeric8 reports
- GORE-TEX Soft Tissue Patch 1310015020Mesh, Surgical, Polymeric7 reports
- GORE-TEX Soft Tissue Patch 1415020010Mesh, Surgical, Polymeric7 reports
- GORE-TEX Soft Tissue Patch 1405010010Mesh, Surgical, Polymeric5 reports
- GORE-TEX Soft Tissue Patch 1305010020Mesh, Surgical, Polymeric4 reports
- GORE-TEX Soft Tissue Patch 1320030020Mesh, Surgical, Polymeric4 reports
- GORE-TEX Soft Tissue Patch 1420030010Mesh, Surgical, Polymeric3 reports
- GORE-TEX Soft Tissue Patch 132603402AMesh, Surgical, Polymeric1 report
- GORE-TEX Soft Tissue Patch 1405015010Mesh, Surgical, Polymeric1 report
Recent GORE-TEX Soft Tissue Patch adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryNov 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6), 2009 WHEREBY A GORE-TEX® SOFT TISSUE PATCH WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6), 2009, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVED DUE TO INFECTION WITH ABSCESS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Abscess; Unspecified Infection
MAUDE report 18083004 ↗InjuryNov 1, 2023Insufficient 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-TEX® SOFT TISSUE PATCH WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2004, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVED DUE TO INFECTION WITH ABDOMINAL WALL SINUS TRACT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Unspecified Infection
MAUDE report 18048261 ↗InjuryNov 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2007 WHEREBY A GORE-TEX® SOFT TISSUE PATCH WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2008, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVED DUE TO RECURRENT HERNIA. MESH WAS FOUND TO BE UNATTACHED. ADHESIONS OF THE BOWEL TO THE MESH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Hernia
MAUDE report 18047607 ↗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 5, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INGUINAL HERNIA REPAIR ON (B)(6) 2017, WHEREBY A GORE-TEX® SOFT TISSUE PATCH 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: INFECTED MESH, EXPLANATION OF MESH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Abscess; Unspecified Infection
MAUDE report 16686530 ↗InjuryApr 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT AN UNKNOWN VENTRAL HERNIA REPAIR ON (B)(6) 2004 WHEREBY A GORE-TEX® SOFT TISSUE PATCH WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2007, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION, CHRONIC PAIN . ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 16668235 ↗InjuryFeb 20, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN UMBILICAL HERNIA REPAIR ON (B)(6) 2004 WHEREBY A GORE-TEX® SOFT TISSUE PATCH 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: INFECTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Erosion; Unspecified Infection
MAUDE report 16405774 ↗InjuryJan 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN LEFT FLANK HERNIA REPAIR ON (B)(6) 2002 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2005 AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION, HERNIA RECURRENCE, SEROMA, OPEN DRAINING WOUND, SEVERE AND CHRONIC PAIN/DISCOMFORT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Abscess; Unspecified Infection
MAUDE report 16194996 ↗InjuryFeb 28, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC PARASTOMAL HERNIA REPAIR ON (B)(6) 2017 WHEREBY A GORE-TEX® SOFT TISSUE PATCH WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2019, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: HERNIA RECURRENCE, SOFT TISSUE ABDOMINAL WALL EXCISION-MESH WITH FIBRINOPURULENT DEBRIS, INFECTED MESH, INFECTED PROSTHETIC MESH OF ABDOMINAL WALL, AND INFECTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Hematoma; Unspecified Infection
MAUDE report 13619985 ↗InjuryJan 4, 2022Insufficient 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-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: REMOVAL OF GORE MESH DUE TO FAILED MESH AND PAIN, RECURRENT HERNIA REPAIRED WITH NEW MESH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Erosion; Inflammation
MAUDE report 13158113 ↗InjuryJan 4, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC PARASTOMAL HERNIA REPAIR ON (B)(6) 2016 WHEREBY A GORE-TEX® SOFT TISSUE PATCH WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2019 AND (B)(6) 2021, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: SURGERY TO REMOVE MESH, MESH ERODING INTO BOWEL, OPEN DRAINING WOUND, INFLAMMATION, BOWEL RESECTION, BOWEL PERFORATION, ADHESIONS TO SMALL INTESTINE, ADHESIONS TO BOWEL, ADHESIONS, HERNIA RECURRENCE, SEVERE AND CHRONIC PAIN/DISCOMFORT, SMALL BOWEL OBSTRUCTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Erosion; Obstruction/Occlusion; Unspecified Infection
MAUDE report 13152462 ↗InjuryAug 19, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT CONGENITAL DIAPHRAGMATIC HERNIA REPAIR ON (B)(6) 2014 WHEREBY A GORE-TEX® SOFT TISSUE PATCH WAS IMPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: PNEUMOPERITONEUM, FREE AIR, CONCERN FOR A PERFORATED VISCUS, LOOP OF SMALL INTESTINE ISCHEMIC AND PERFORATED, SEROSAL TEAR, RESECT 30CM SEGMENT OF SMALL BOWEL, ISCHEMIC SMALL BOWEL, OSTOMY MUCOUS FISTULA FORMATION, ADHESIONS, MEDIAL RECURRENCE, SPLEEN ADHERENT TO PATCH, STOMACH, COLON, AND PANCREAS WERE WITHIN THE CHEST, COLON HERNIATED INTO THE CHEST. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Hernia; No Clinical Signs, Symptoms or Conditions
MAUDE report 12346042 ↗InjuryAug 19, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN ABDOMINAL HERNIA REPAIR ON (B)(6) 2005 AND (B)(6) 2011 WHEREBY A GORE-TEX® SOFT TISSUE PATCH AND A GORE® DUALMESH® BIOMATERIAL WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2012 AND (B)(6) 2013, ADDITIONAL PROCEDURES OCCURRED WHEREBY A GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: BOWEL OBSTRUCTION, RECURRENCES, MULTIPLE LYSIS OF DENSE ADHESIONS, REMOVAL OF MESH, BOWEL PERFORATION, MULTIPLE ROUNDS OF TREATING INFECTED MESH WITH ABSCESSES, MESH MIGRATION, AND PAIN AND SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Abscess; No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion; Unspecified Infection
MAUDE report 12345814 ↗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 ↗InjuryApr 30, 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. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 11757607 ↗
Other W. L. Gore & Associates, Inc. products
- GORE EXCLUDER AAA Endoprosthesis81 models · 1,121 reports
- GORE DRYSEAL FLEX Introducer Sheath29 models · 1,009 reports
- GORE EXCLUDER AAA Endoprosthesis with C3 Delivery51 models · 988 reports
- GORE DUALMESH PLUS BIOMATERIAL12 models · 734 reports
- GORE VIABAHN VBX Balloon Expandable Endo111 models · 557 reports · 1 recall
- GORE DUALMESH Biomaterial13 models · 485 reports
- GORE EXCLUDER Iliac Branch Endoprosthesis6 models · 469 reports
- GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral10 models · 427 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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