GORE-TEX Soft Tissue Patch 1315020020Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00733132600526), received between Feb 5, 2019 and Nov 7, 2023 — classified as 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (12 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 12 most recent of 12 reports, 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 ↗
• 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 ↗
• InjuryAug 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC MORGAGNI HERNIA REPAIR ON (B)(6) 2016 WHEREBY A GORE-TEX® SOFT TISSUE PATCH WAS IMPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: PAIN, SMALL BOWEL OBSTRUCTION, RECURRENT HERNIAS, FAILURE OF GORE MESH, MESH REVISION, MESH REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia; No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 10440021 ↗
• InjuryAug 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LEFT INGUINAL HERNIA REPAIR ON (B)(6) 2007 WHEREBY A GORE-TEX® SOFT TISSUE PATCH WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2010, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: SURGERY TO REMOVE MESH, GROSS PUS, OPEN DRAINING WOUND, INFECTION, HERNIA RECURRENCE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 10396888 ↗
• InjuryMay 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2016 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: INFECTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Tissue Breakdown; Unspecified Infection

  MAUDE report 10020227 ↗
• InjuryDec 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN LEFT INGUINAL HERNIA REPAIR ON (B)(6) 2010 WHEREBY A GORE-TEX® SOFT TISSUE PATCH WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2018, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: HERNIA RECURRENCE, REVISION SURGERY, CHRONIC PAIN, HERNIA SAC ADHERENT TO MESH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 9419590 ↗
• InjurySep 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2005, 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: ABDOMINAL PAIN, INFECTED MESH, OPEN DRAINING WOUND, A MESH REMOVAL, ADDITIONAL SURGERY ((B)(6) 2007, (B)(6) "1008"). ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abdominal Pain; No Clinical Signs, Symptoms or Conditions; No Code Available; Unspecified Infection

  MAUDE report 8969655 ↗
• InjuryJun 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT A LAPAROSCOPIC DIAPHRAGMATIC HERNIA REPAIR ON (B)(6) 2013 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: ADHESIONS, INFECTION, HERNIA RECURRENCE, SWISS CHEESE DEFECT, COMPONENT SEPARATION, OPEN DRAINING WOUND, CHRONIC ABDOMINAL PAIN, SCARRING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Adhesion(s); Hernia; No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 8704771 ↗
• InjuryMay 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2010, 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: MESH INFECTION, DEBRIDEMENT, MESH REMOVAL, ADDITIONAL SURGERIES. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 8579351 ↗
• InjuryApr 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2017 WHEREBY A ¿GORE-TEX SOFT MESH¿ WAS IMPLANTED. THE FOLLOWING WAS REPORTED: ¿PATIENT DEVELOPED OPEN WOUNDS AND MESH INFECTION SEVERAL MONTHS AFTER PLACEMENT. ON (B)(6) 2017, PT. UNDERWENT SURGERY FOR IRRIGATION, DEBRIDEMENT AND PARTIAL REMOVAL OF THE GORE MESH. PURULENT MATERIAL WAS OBSERVED ABOVE AND BENEATH THE MESH. THE MESH WAS ALSO NOTED TO BE CONTRACTED/BULGING. ON [SIC] A PORTION OF THE MESH COULD BE REMOVED, SO INFECTED MESH WAS STILL IMPLANTED. HE REQUIRED A SECOND SURGICAL DEBRIDEMENT ON (B)(6) 2017 WITH APPLICATION OF A WOUND VAC FOR THE WOUND. [THE PATIENT] WAS AGAIN ADMITTED FROM (B)(6) 2017 DUE TO MESH INFECTION AND FOR REMOVAL OF THE REMAINING PIECES OF GORE TEX MESH. HE HAD BEEN UNDERGOING TREATMENT WITH THE WOUND VAC AND ANTIBIOTICS SINCE HIS DISCHARGE IN (B)(6) 2017 TO PREPARE FOR SURGICAL REMOVAL". IT WAS ALLEGED THAT ¿ON (B)(6) 2017, [THE PATIENT] UNDERWENT OPEN SURGERY TO REMOVE THE INFECTED MESH AND FOR FURTHER TISSUE DEBRIDEMENT. A WOUND VAC WAS AGAIN PLACED TO ALLOW FOR DELAYED HEALING AND SUBSEQUENT REPAIR. ON (B)(6) 2017, HE REQUIRED ANOTHER SURGICAL PROCEDUR

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

  MAUDE report 8558574 ↗
• InjuryFeb 5, 2019No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; 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. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: DISSECTION OF GORE MESH FROM BOWEL, RESECTION OF BOWEL, ADDITIONAL SURGERY, EXTENSIVE ADHESIONS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Adhesion(s); No Code Available; Not Applicable

  MAUDE report 8306470 ↗