GORE-TEX Soft Tissue Patch 1420030010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132600618), received between May 8, 2020 and Feb 28, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2004 WHEREBY A GORE-TEX® SOFT TISSUE PATCH 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: REMOVAL OF INFECTED MESH; INFECTION; ABSCESS; FISTULA; ADHESIONS; BOWEL RESECTION; GRANULATION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Fistula; Unspecified Infection

  MAUDE report 10037803 ↗