GORE DUALMESH PLUS BIOMATERIALRecalls & reported problems across all models
W. L. Gore & Associates, Inc. · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 734
- Deaths reported
- 1
- Injuries reported
- 733
- Recalls
- 0
We found 12 models of GORE DUALMESH PLUS BIOMATERIAL by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 734 adverse event reports in the FDA's MAUDE database, received between Jun 26, 2018 and May 22, 2026 — classified as 1 death, 733 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (715 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 problems
Device problems
- Insufficient Device Problem Information715
- No Apparent Adverse Event39
- Adverse Event Without Identified Device or Use Problem27
- Patient Device Interaction Problem10
- Contamination9
- Microbial Contamination of Device7
- Migration6
- Loosening of Implant Not Related to Bone-Ingrowth4
Patient problems
- No Clinical Signs, Symptoms or Conditions354
- Unspecified Infection351
- Hernia185
- No Code Available179
- Adhesion(s)136
- Abscess111
- Obstruction/Occlusion108
- Seroma83
GORE DUALMESH PLUS BIOMATERIAL models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GORE DUALMESH PLUS BIOMATERIAL 1DLMCP04Mesh, Surgical, Polymeric210 reports
- GORE® DUALMESH® PLUS BIOMATERIAL 1DLMCP03Mesh, Surgical, Polymeric149 reports
- GORE DUALMESH PLUS BIOMATERIAL 1DLMCP06Mesh, Surgical, Polymeric117 reports
- GORE® DUALMESH® PLUS BIOMATERIAL 1DLMCP08Mesh, Surgical, Polymeric94 reports
- GORE DUALMESH PLUS BIOMATERIAL 1DLMCP07Mesh, Surgical, Polymeric1 death87 reports
- GORE DUALMESH PLUS BIOMATERIAL 1DLMCP02Mesh, Surgical, Polymeric38 reports
- GORE DUALMESH PLUS BIOMATERIAL 1DLMCP05Mesh, Surgical, Polymeric22 reports
- GORE® DUALMESH® PLUS BIOMATERIAL 1DLMCP203Mesh, Surgical, Polymeric6 reports
- GORE® DUALMESH® PLUS BIOMATERIAL 1DLMCP201Mesh, Surgical, Polymeric4 reports
- GORE DUALMESH PLUS BIOMATERIAL 1DLMCP200Mesh, Surgical, Polymeric3 reports
- GORE® DUALMESH® PLUS BIOMATERIAL 1DLMCP202Mesh, Surgical, Polymeric3 reports
- GORE® DUALMESH® PLUS BIOMATERIAL 1DLMCP204Mesh, Surgical, Polymeric1 report
Recent GORE DUALMESH PLUS BIOMATERIAL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 22, 2026Insufficient 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 WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6), 2018, AND (B)(6) 2019, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: HERNIA RECURRENCE, INFECTION, ABSCESS, DENSE ADHESIONS, WOUND VAC. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Abscess; Unspecified Infection
MAUDE report 25259826 ↗InjuryFeb 26, 2026Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2003, WHEREBY A GORE® DUALMESH PLUS® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2024, AND (B)(6) 2024, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: BOWEL RESECTION, INFECTION, BOWEL OBSTRUCTION, PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Obstruction/Occlusion
MAUDE report 24464210 ↗InjuryAug 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2012, WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADHESIONS, SEROMA/NECROTIC FLUID, ABDOMINAL CYST, HERNIA RECURRENCE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Seroma
MAUDE report 22926169 ↗InjuryDec 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN UMBILICAL VENTRAL HERNIA REPAIR ON (B)(6) 2010 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Unspecified Infection
MAUDE report 20856339 ↗InjuryNov 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6 2011 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. IT WAS ALSO REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2015 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2020, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH PULLED AWAY FROM ABDOMINAL WALL; MESH SEPARATED FROM FASCIA; RECURRENCES; CHRONIC SEROMA; MESH ADHERENT TO BOWEL; DENSE ADHESIONS; HERNIAS RECURRED IN GAPS WITHIN THE MESH; FOREIGN BODY GIANT CELL REACTION (INFLAMMATION); MESH REMOVAL SURGERIES. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Hernia; Seroma
MAUDE report 20734187 ↗InjuryNov 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2011 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. IT WAS ALSO REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2015 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2020, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH PULLED AWAY FROM ABDOMINAL WALL; MESH SEPARATED FROM FASCIA; RECURRENCES; CHRONIC SEROMA; MESH ADHERENT TO BOWEL; DENSE ADHESIONS; HERNIAS RECURRED IN GAPS WITHIN THE MESH; FOREIGN BODY GIANT CELL REACTION (INFLAMMATION); MESH REMOVAL SURGERIES. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Hernia; Seroma
MAUDE report 20734175 ↗InjuryJun 5, 2024Insufficient 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 WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2022, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: (B)(6) 2022 - EXPLANTATION OF ABDOMINAL WALL HERNIOPLASTY MESH FOR INFECTION. PLACEMENT OF WOUND VAC. ¿AS EXPECTED, THE MESH WAS NOT INCORPORATED AND COULD EASILY BE PULLED OFF OF THE ABDOMINAL WALL. SUPERFICIAL TO THE MESH WAS A CHRONIC ABSCESS CAVITY WITH INFECTED APPEARING FLUID¿. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Abscess; Unspecified Infection
MAUDE report 19468151 ↗InjuryApr 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC UMBILICAL HERNIA REPAIR ON (B)(6) 2017 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2018, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTED MESH, SEVERE BACTERIAL SEPSIS, MESH REMOVAL, ABSCESS, ADHESIONS, WOUND DEHISCENCE, WOUND DEBRIDEMENT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Abscess; Unspecified Infection
MAUDE report 19163288 ↗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) 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
MAUDE report 19106363 ↗InjuryApr 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2019 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2023, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: FISTULA, ADHESIONS, ADHESIONS OF BOWEL TO MESH, BOWEL RESECTION, PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Seroma
MAUDE report 19059132 ↗InjuryApr 8, 2024Insufficient 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® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6), 2023, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: FISTULA, BOWEL ADHESION TO MESH, ADHESIONS, BOWEL RESECTION, FIBROSIS, INFLAMMATION, PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Fistula; Obstruction/Occlusion; Unspecified Infection
MAUDE report 19058797 ↗InjuryFeb 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2002 WHEREBY TWO GORE® DUALMESH® PLUS BIOMATERIAL WERE 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: ADHESIONS TO BOWEL, HERNIA RECURRENCE, MESH DISRUPTION, SMALL BOWEL OBSTRUCTION, ADHESIONS, OPEN DRAINING WOUND, SURGERY TO REMOVE PARTIAL MESH, EXPOSED MESH, INFECTION, FISTULA, BOWEL RESECTION, SCARRING, SURGERY TO REMOVE MESH, ABDOMINAL WALL RECONSTRUCTION, GROSS PURULENCE ON MESH, ABSCESS, MESH DETACHMENT, SUCCUS STAINING ON MESH, SMALL BOWEL FISTULA TO MESH, ADHESIONS TO SMALL INTESTINE, CHRONIC INFLAMMATION, INFLAMMATION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Hernia
MAUDE report 18632400 ↗InjuryFeb 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2002 WHEREBY TWO GORE® DUALMESH® PLUS BIOMATERIAL WERE 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: ADHESIONS TO BOWEL, HERNIA RECURRENCE, MESH DISRUPTION, SMALL BOWEL OBSTRUCTION, ADHESIONS, OPEN DRAINING WOUND, SURGERY TO REMOVE PARTIAL MESH, EXPOSED MESH, INFECTION, FISTULA, BOWEL RESECTION, SCARRING, SURGERY TO REMOVE MESH, ABDOMINAL WALL RECONSTRUCTION, GROSS PURULENCE ON MESH, ABSCESS, MESH DETACHMENT, SUCCUS STAINING ON MESH, SMALL BOWEL FISTULA TO MESH, ADHESIONS TO SMALL INTESTINE, CHRONIC INFLAMMATION, INFLAMMATION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Hernia
MAUDE report 18630160 ↗InjuryDec 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6), 2007 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6), 2020, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: CHRONIC PAIN, MESH REMOVAL, ADDITIONAL SURGERY; ADHESIONS; RECURRENCE; PAIN AND SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Bowel Perforation
MAUDE report 18347670 ↗InjuryDec 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(3) 2007 WHEREBY A GORE® MYCROMESH® BIOMATERIAL WAS IMPLANTED. PATIENT UNDERWENT A SECOND OPEN INCISION HERNIA REPAIR ON (B)(3) 2007 WHEREBY A GORE® MYCROMESH® BIOMATERIAL WAS IMPLANTED. PATIENT ALSO UNDERWENT A THIRD INCISIONAL HERNIA REPAIR ON (B)(3) 2009 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(3) 2007 AND (B)(3) 2009, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MULTIPLE RECURRENT HERNIAS WITH ADHESIONS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Hernia
MAUDE report 18343666 ↗
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 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
- GORE TAG Conformable Thoracic Stent Graft25 models · 325 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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