GORE® DUALMESH® PLUS BIOMATERIAL HOLES 1DLMCPH07Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132601264), received between Feb 27, 2019 and Oct 11, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL INCISIONAL HERNIA REPAIR ON (B)(6) 2003 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2008, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERIES; RECURRENCE; ADHESIONS; MESH MIGRATION; MESH REMOVAL; NECROTIC & STRANGULATED OMENTUM; SEROMA; WOUND DEBRIDEMENT; WOUND VAC. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 15583461 ↗
• InjuryMay 19, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2006 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES 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, PAIN, FAILED. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 14439936 ↗
• InjuryMar 25, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) , 2006 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES 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; RECURRENT VENTRAL HERNIA; ABSCESS; SINUS TRACT; FISTULA TRACT; INFECTION; CHRONIC ABDOMINAL FLUID COLLECTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Fistula; Unspecified Infection

  MAUDE report 11571190 ↗
• InjuryAug 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2005 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES 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: ABDOMINAL PAIN, ABSCESS, INFECTED MESH, MULTIPLE DEBRIDEMENT PROCEDURES, MESH REMOVAL, ADDITIONAL SURGERY ((B)(6) 2005, (B)(6) 2006). ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 8946633 ↗
• InjuryAug 29, 2019Insufficient 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 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: ABDOMINAL WALL INFECTION WITH I&D ON (B)(6) 2015, MESH INFECTION AND ABDOMINAL WALL ABSCESS, MESH REMOVAL REQUIRING AN ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 8945264 ↗
• InjuryMar 21, 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)2001 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES WAS IMPLANTED. IT WAS REPORTED THE PATIENT WAS ADDITIONALLY IMPLANTED WITH A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES ON (B)(6) 2003.

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

  MAUDE report 8442338 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2006, WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2006, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2006, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION OF MESH, REMOVAL OF MESH (2X), MESH EXPOSED POSTOPERATIVELY, SEROMA, ADDITIONAL SURGERIES. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Code Available; Seroma; Tissue Breakdown; Unspecified Infection

  MAUDE report 8374266 ↗