GORE DUALMESH PLUS BIOMATERIAL HOLESRecalls & reported problems across all models
W. L. Gore & Associates, Inc. · 6 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 66
- Deaths reported
- 0
- Injuries reported
- 66
- Recalls
- 0
We found 6 models of GORE DUALMESH PLUS BIOMATERIAL HOLES by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 66 adverse event reports in the FDA's MAUDE database, received between Jun 27, 2018 and Apr 15, 2024 — classified as 66 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (64 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported GORE DUALMESH PLUS BIOMATERIAL HOLES problems
Device problems
- Insufficient Device Problem Information64
- Adverse Event Without Identified Device or Use Problem2
- No Apparent Adverse Event2
- Appropriate Device Problem Term/Code Not Available1
- Contamination1
- Device Appears to Trigger Rejection1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Microbial Contamination of Device1
Patient problems
- Unspecified Infection38
- No Clinical Signs, Symptoms or Conditions35
- Adhesion(s)13
- Fistula12
- Obstruction/Occlusion12
- Hernia11
- Abscess10
- Pain6
GORE DUALMESH PLUS BIOMATERIAL HOLES models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GORE® DUALMESH® PLUS BIOMATERIAL HOLES 1DLMCPH04Mesh, Surgical, Polymeric23 reports
- GORE® DUALMESH® PLUS BIOMATERIAL HOLES 1DLMCPH06Mesh, Surgical, Polymeric14 reports
- GORE® DUALMESH® PLUS BIOMATERIAL HOLES 1DLMCPH08Mesh, Surgical, Polymeric9 reports
- GORE® DUALMESH® PLUS BIOMATERIAL HOLES 1DLMCPH03Mesh, Surgical, Polymeric8 reports
- GORE® DUALMESH® PLUS BIOMATERIAL HOLES 1DLMCPH07Mesh, Surgical, Polymeric7 reports
- GORE® DUALMESH® PLUS BIOMATERIAL HOLES 1DLMCPH02Mesh, Surgical, Polymeric5 reports
Recent GORE DUALMESH PLUS BIOMATERIAL HOLES adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2011 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES WAS IMPLANTED AND ON (B)(6) 2014 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2014 AND (B)(6) 2023, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: HERNIA RECURRENCE, REMOVAL, BOWEL INVOLVEMENT, ADHESIONS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Hernia; No Clinical Signs, Symptoms or Conditions
MAUDE report 19106085 ↗InjuryNov 15, 2023Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2003 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2004 AND (B)(6) 2017, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION, MESH REMOVAL, RECURRENCE, ADHESIONS, PAIN AND SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED. INFORMATION FROM OUTSIDE OF GORE RECEIVED ON SEPTEMBER 16, 2022 CHANGED THE ALLEGATIONS TO: ADDITIONAL SURGERIES; ENTEROTOMY; INFECTION, MESH REMOVAL, RECURRENCE, ADHESIONS, WOUND VAC; SERMOA; SMALL BOWEL OBSTRUCTION; EMESIS; PAIN AND SUFFERING. INFORMATION FROM OUTSIDE OF GORE RECEIVED ON SEPTEMBER 16, 2022 CONTAINED THE FOLLOWING: EXPLANT PHYSICIAN #2 CHANGED FROM (B)(6) M.D. TO (B)(6) MD.; EXPLANT DATE #3: (B)(6) 2017, EXPLANT PHYSICIAN #3: (B)(6) M.D.; EXPLANT LOCATION (HOSPITAL, STATE) #3: (B)(6) MEDICAL CENTER .
Patient problems: Seroma; Unspecified Infection
MAUDE report 18140929 ↗InjuryOct 16, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2003 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2003, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVED DUE TO INFECTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Unspecified Infection
MAUDE report 17946892 ↗InjurySep 11, 2023Migration; Migration
THE FOLLOWING INFORMATION WAS OBTAINED FROM MEDICAL RECORDS. IMPLANT PROCEDURE: REPAIR OF VENTRAL INCISIONAL HERNIA WITH GORE-TEX DUAL MESH PLUS BIOMATERIAL. [IMPLANT: GORE® DUALMESH® PLUS BIOMATERIAL, 1DLMCPH06/(B)(6), 18CM X 24 CM X 1 MM THICK]. IMPLANT DATE: (B)(6) 2008. EXPLANT PROCEDURE: ABDOMINAL EXPLORATION. LYSIS OF ADHESIONS. REMOVAL OF OLD MESH. EXTENSIVE FASCIAL RESECTION. VENTRAL HERNIORRHAPHY WITH 10 X 8¿ BARD VENTRIO ST MESH. EXPLANT DATE: (B)(6) 2014. IMPLANT #1: 5700-1. IT WAS INITIALLY REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL 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: BOWEL OBSTRUCTION, DENSE ADHESIONS, RECURRENCE, MESH MIGRATION, REMOVAL OF OLD MESH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Hernia
MAUDE report 17724361 ↗InjuryFeb 20, 2023Patient-Device Incompatibility; Insufficient 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) 2013, 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: Unspecified Infection
MAUDE report 16405243 ↗InjuryJan 31, 2023Insufficient 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 AND ON (B)(6) 2012 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2008 AND (B)(6) 2010 AND (B)(6) 2010, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERIES; MULTIPLE RECURRENCES; MESH REMOVAL; INFECTED MESH; SEROMA; SEROSAL TEAR; WOUND VAC PAIN & SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Hernia; Unspecified Infection
MAUDE report 16271724 ↗InjuryOct 11, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2002 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2008, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERIES; RECURRENCE; SEROMA,; INFECTED MESH; MESH MIGRATION; GRANULOMAS; MESH REMOVAL; WOUND VAC; DENSE ADHESIONS; PAIN & SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Unspecified Infection
MAUDE report 15583610 ↗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 ↗InjuryAug 19, 2022Insufficient 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) 2013, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERY; MESH REMOVAL; BOWEL RESECTION; INFECTED MESH; FISTULA; ABSCESS; WOUND VAC; SEROMA; NECROTIC TISSUE; PAIN & SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Fistula; No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 15259492 ↗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 ↗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 ↗InjuryMay 23, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL 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: ADHESIONS, RECURRENCE, SEROMA, AND REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Hernia; Seroma
MAUDE report 14477614 ↗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 ↗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) 2010 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: PAIN AND DISCOMFORT, MESH INFECTION, FAILED INCORPORATION OF MESH, AND SEROMA. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Seroma; Unspecified Infection
MAUDE report 14436211 ↗InjuryFeb 8, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2004 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WITH HOLES WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2005, (B)(6) 2005, (B)(6) 2006, AND (B)(6) 2008 ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERY, INFECTION, MESH REMOVAL, RECURRENCE, REVISION, BILATERAL COMPONENT SEPARATION, DEBRIDEMENT OF SCAR TISSUE AND FIBROSIS, DRAINAGE OF PURULENT MATERIAL, REOPENING OF WOUND, PAIN AND SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Unspecified Infection
MAUDE report 13486271 ↗
Other W. L. Gore & Associates, Inc. products
- GORE EXCLUDER AAA Endoprosthesis81 models · 1,121 reports
- GORE DRYSEAL FLEX Introducer Sheath29 models · 1,009 reports
- GORE EXCLUDER AAA Endoprosthesis with C3 Delivery51 models · 988 reports
- GORE DUALMESH PLUS BIOMATERIAL12 models · 734 reports
- GORE VIABAHN VBX Balloon Expandable Endo111 models · 557 reports · 1 recall
- GORE DUALMESH Biomaterial13 models · 485 reports
- GORE EXCLUDER Iliac Branch Endoprosthesis6 models · 469 reports
- GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral10 models · 427 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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