GORE-TEX Soft Tissue Patch 1405010010Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132600564), received between Apr 16, 2019 and Feb 20, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryMay 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: CHRONIC PAIN, MESH REVISION, ADDITIONAL SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 8579923 ↗
• InjuryApr 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT AN UNSPECIFIED LAPAROSCOPIC HERNIA REPAIR ON (B)(6) 2006 WHEREBY A GORE-TEX® SOFT TISSUE PATCH WAS IMPLANTED. THE FOLLOWING WAS REPORTED: ¿ON (B)(6) 2016, (THE PATIENT) REQUIRED SURGERY SECONDARY TO THE GORE MESH CAUSING A SEVERE "FOREIGN BODY REACTION" AND MIGRATING. THE MESH WAS REMOVED AND DESCRIBED AS ¿MESH GRANULOMA.¿ A PHOTO WAS TAKEN OF THE EXPLANTED MESH.¿ IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING PRODUCT DEFICIENCIES: STRICT PRODUCTS LIABILITY, NEGLIGENCE, IMPLIED AND ESPRESS WARRANTY, FRAUD, FRAUDULENT CONCEALMENT, PUNITIVE DAMAGES. ADDITIONAL EVENT SPECIFIC INFORMATION AND MEDICAL RECORDS HAVE BEEN REQUESTED.

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

  MAUDE report 8558646 ↗
• InjuryApr 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT A PATIENT UNDERWENT A HERNIA REPAIR ON (B)(6) 2012 WHEREBY A "GORE-TEX SOFT TISSUE PATCH" WAS IMPLANTED. IT WAS REPORTED TO GORE THAT THE DEVICE "WAS INFECTED AND REMOVED ON (B)(6) 2017." IT WAS REPORTED TO GORE THAT THE PATIENT "UNDERWENT A SURGERY TWO (2) WEEKS EARLIER, WHICH RESULTED IN REMOVAL OF OBSTRUCTED AND HERNIA-INCARCERATED BOWEL, BUT LEAVING IN PLACE THE INFECTED MESH." IT WAS REPORTED TO GORE THAT ¿IN THE DAYS FOLLOWING SURGERY, [THE PATIENT¿S] KIDNEYS FAILED." SHE GAINED 30 POUNDS DUE TO FLUID RETENTION. IT WAS REPORTED TO GORE THAT ¿WOUND VAC PROCEDURES" WERE USED FOR A MONTH. IT WAS REPORTED TO GORE THAT THE PATIENT ¿WAS OUT OF WORK FROM (B)(6) 2017 UNTIL (B)(6) 2017. BETWEEN (B)(6) 2017 AND (B)(6) 2018, [THE PATIENT] WORKED PART-TIME AS SHE WAS ABLE. SHE RESUMED FULL TIME WORK (37.5 HOURS PER WEEK) ON (B)(6) 2018." IT WAS REPORTED TO GORE THAT ¿...WHEN SHE COMES HOME FROM WORK, SHE IS SHAKY AND SOMETIMES CRYING. SHE FREQUENTLY FEELS CHILLS. SHE LOST HER HAIR. HER LEGS ARE WEAK. HER FEET OFTEN FEEL NUMB. SHE DOES NOT HAVE THE ENERGY THAT SHE HAD BEFORE. SHE HAS DIFFICULTY WALKING UP A HILL. SHE HAS LOST SOME BOWEL CONTROL. SHE VISITS THE

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion; Renal Failure; Unspecified Infection

  MAUDE report 8520054 ↗