GORE® DUALMESH® PLUS BIOMATERIAL HOLES 1DLMCPH03Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00733132601233), received between May 1, 2019 and Aug 17, 2022 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2002 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2003 AND (B)(6) 2005, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERIES; ADHESIONS; MESH REMOVAL; RECURRENCE; BOWEL RESECTION; INFECTED MESH; SEROMA; ABSCESS; WOUND VAC; PAIN & SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 15245832 ↗
• InjuryJan 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL INCISIONAL HERNIA REPAIR ON (B)(6) 2003, AND (B)(6) 2015 WHEREBY GORE® DUALMESH® PLUS BIOMATERIAL DEVICES WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2003 AND (B)(6) 2017, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF GORE MESH BECAUSE THERE WAS A SMALL DEFECT ON THE RIGHT SIDE OF THE MESH, BOWEL WAS FREED FROM THE EDGES OF THE WOUND, RECURRENT INCISIONAL HERNIA DEFECT REPAIRED WITH PLACEMENT OF NEW MESH, ADHESIONS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 11158846 ↗
• InjuryAug 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2008 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2014, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH CONTRACTED RESULTING IN RECURRENCE AND ADDITIONAL HERNIA REPAIR. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 10390920 ↗
• InjuryDec 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN UMBILICAL HERNIA REPAIR ON (B)(6) 2008 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2012 AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ABSCESS, INFECTION, SURGERY TO REMOVE MESH, FISTULA. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 9433253 ↗
• InjuryNov 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT INCISIONAL HERNIA REPAIR ON (B)(6) 2010 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL 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: REMOVAL OF INFECTED MESH AND DEBRIDEMENT OF ABDOMINAL WOUND. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 9275911 ↗
• InjurySep 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2007 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES 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: MESH REMOVAL REQUIRING AN ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 9128123 ↗
• InjurySep 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2010 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2017, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVAL AND ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 9112508 ↗
• InjuryMay 1, 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) 2007, WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES 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: ADHESIONS, ADHESIONS TO BOWEL, HERNIA RECURRENCE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Adhesion(s); Fistula; Hernia; Unspecified Infection

  MAUDE report 8571623 ↗