GORE® DUALMESH® PLUS BIOMATERIAL HOLES 1DLMCPH02Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132601226), received between Apr 30, 2019 and Jun 30, 2022 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryJun 30, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2013 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES 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: ADDITIONAL SURGERIES, MULTIPLE EMERGENCY ROOM VISITS, INFECTION, INFECTED MESH, MESH REMOVAL, SEROMA, INFLAMMATION, IMPAIRED NERVE FUNCTIONING, CHRONIC PAIN & SUFFERING WITH NEUROPATHIC SYMPTOMS, MUSCLE PAIN BLOCKS WITH ULTRASOUND. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 14877079 ↗
• InjuryNov 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2005 AND (B)(6) 2007 WHEREBY TWO GORE DUALMESH PLUS BIOMATERIAL WITH HOLES WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2007, (B)(6) 2012, AND (B)(6) 2012 ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF INFECTED GORE MESH, RESECTION OF BOWEL DUE TO GORE MESH EROSION. RECURRENT VENTRAL HERNIA DEFECT REPAIRED WITH PLACEMENT OF NEW MESH, FISTULA, EXTENSIVE HERNIATION OF INTESTINE AND OMENTUM INTO HERNIA DEFECT, DRAINAGE OF FLUID AROUND THE GORE MESH, EXTENSIVE ADHESIONS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 10862479 ↗
• InjuryAug 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2009 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL 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: BILATERAL PULMONARY EMBOLISM, AND THE SUBSEQUENT ANTICOAGULANT TREATMENT CAUSED AN INTRA-ABDOMINAL HEMORRHAGE, CREATING AN ENORMOUS HEMATOMA, PAIN AND ABDOMINAL DISTENSION, AS WELL AS ANEMIA ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pulmonary Embolism

  MAUDE report 10443081 ↗
• InjurySep 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN RIGHT SPIGELIAN HERNIA REPAIR ON (B)(6) 2003 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL 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: MESH WAS BALLED UP AND REMOVED. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 9135557 ↗
• InjuryApr 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2008, WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES 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: SMALL SEROMA OVERLYING VENTRAL HERNIA REPAIR SITE; SEVERAL SMALL SEROMAS OVER REPAIR AREA; PROBABLE HEMATOMA, ADHESIONS, CHRONIC ABDOMINAL PAIN, MESH SEPARATION, SURGERY TO REMOVE MESH, FOREIGN BODY GIANT CELL REACTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Adhesion(s); Hematoma; Hernia; Pain

  MAUDE report 8567319 ↗