GORE DUALMESH BiomaterialRecalls & reported problems across all models
W. L. Gore & Associates, Inc. · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 485
- Deaths reported
- 0
- Injuries reported
- 485
- Recalls
- 0
We found 13 models of GORE DUALMESH Biomaterial by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 485 adverse event reports in the FDA's MAUDE database, received between Jun 26, 2018 and Sep 5, 2025 — classified as 485 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (477 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 Biomaterial problems
Device problems
- Insufficient Device Problem Information477
- No Apparent Adverse Event25
- Adverse Event Without Identified Device or Use Problem17
- Contamination8
- Microbial Contamination of Device6
- Patient Device Interaction Problem5
- Improper or Incorrect Procedure or Method4
- Loosening of Implant Not Related to Bone-Ingrowth3
Patient problems
- No Clinical Signs, Symptoms or Conditions262
- Unspecified Infection239
- Hernia127
- No Code Available119
- Adhesion(s)101
- Abscess69
- Obstruction/Occlusion58
- Pain54
GORE DUALMESH Biomaterial models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GORE DUALMESH Biomaterial 1DLMC04Mesh, Surgical, Polymeric117 reports
- GORE DUALMESH Biomaterial 1DLMC03Mesh, Surgical, Polymeric85 reports
- GORE DUALMESH Biomaterial 1DLMC07Mesh, Surgical, Polymeric74 reports
- GORE DUALMESH Biomaterial 1DLMC06Mesh, Surgical, Polymeric61 reports
- GORE DUALMESH Biomaterial 1DLMC02Mesh, Surgical, Polymeric47 reports
- GORE DUALMESH Biomaterial 1DLMC08Mesh, Surgical, Polymeric43 reports
- GORE DUALMESH Biomaterial 1DLMC05Mesh, Surgical, Polymeric22 reports
- GORE DUALMESH Biomaterial 1DLMC200Mesh, Surgical, Polymeric11 reports
- GORE DUALMESH Biomaterial 1DLMC201Mesh, Surgical, Polymeric8 reports
- GORE DUALMESH Biomaterial 1DLMC09Mesh, Surgical, Polymeric5 reports
- GORE DUALMESH Biomaterial 1DLMC203Mesh, Surgical, Polymeric5 reports
- GORE DUALMESH Biomaterial 1DLMC204Mesh, Surgical, Polymeric5 reports
- GORE DUALMESH Biomaterial 1DLMC202Mesh, Surgical, Polymeric2 reports
Recent GORE DUALMESH Biomaterial adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6), 2022 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6), 2024, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: EXTENSIVE ADHESIOLYSIS FOR 2 HRS. ENTIRE ABDOMINAL WALL FREED OF ADHESIONS, BOWEL SIGNIFICANTLY ADHERED TO MESH-MESH WAS CONTRACTED CAUSING MESHOMA WITH SEVERE CHRONIC INFLAMMATION. LIKELY CAUSE OF CHRONIC ABDOMINAL WALL PAIN. ALL LAYERS OF ABDOMINAL MESH (6 SHEETS TOTAL), TACKS AND SUTURES REMOVED. ABDOMINAL RECONSTRUCTION REQUIRED TO ACHIEVE SAFE, DURABLE CLOSURE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Hernia; Inflammation
MAUDE report 22977099 ↗InjurySep 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2022 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2024, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: EXTENSIVE ADHESIOLYSIS FOR 2 HRS. ENTIRE ABDOMINAL WALL FREED OF ADHESIONS, BOWEL SIGNIFICANTLY ADHERED TO MESH-MESH WAS CONTRACTED CAUSING MESHOMA WITH SEVERE CHRONIC INFLAMMATION. LIKELY CAUSE OF CHRONIC ABDOMINAL WALL PAIN. ALL LAYERS OF ABDOMINAL MESH (6 SHEETS TOTAL), TACKS AND SUTURES REMOVED. ABDOMINAL RECONSTRUCTION REQUIRED TO ACHIEVE SAFE, DURABLE CLOSURE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Hernia; Inflammation
MAUDE report 22977084 ↗InjuryJan 27, 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® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2024, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: HEMATOMA, INFECTION, PAIN, RECURRENCE, ADHESIONS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Hematoma
MAUDE report 21247506 ↗InjuryNov 19, 2024Insufficient 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 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. IT WAS ALSO REPORTED TO GORE THAT THE PATIENT UNDERWENT ADDITIONAL HERNIA REPAIR ON (B)(6) 2004 WHEREBY A GORE® DUALMESH® BIOMATERIAL 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: MESH REMOVAL; MESH FAILURE TO INCORPORATE; MESH PULLED AWAY FROM TISSUE; DENSE ADHESIONS; RECURRENCE; FIBROSIS; INFLAMMATION; LONG HOSPITALIZATION FOR REMOVAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Hernia
MAUDE report 20723549 ↗InjuryNov 19, 2024Insufficient 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 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. IT WAS ALSO REPORTED TO GORE THAT THE PATIENT UNDERWENT ADDITIONAL HERNIA REPAIR ON (B)(6) 2004 WHEREBY A GORE® DUALMESH® BIOMATERIAL 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: MESH REMOVAL; MESH FAILURE TO INCORPORATE; MESH PULLED AWAY FROM TISSUE; DENSE ADHESIONS; RECURRENCE; FIBROSIS; INFLAMMATION; LONG HOSPITALIZATION FOR REMOVAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Hernia
MAUDE report 20723536 ↗InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PHYSICIAN WAS PERFORMING A REINTERVENTION FOR A PATIENT HE RECENTLY IMPLANTED A GORE® DUALMESH® BIOMATERIAL DEVICE. WHEN THE PHYSICIAN WAS EXPLORING THE PATIENT LAPAROSCOPICALLY, HE SAW A LOT OF ADHESIONS AND SEROMA WITH A LOT OF CONTRACTION. THE IMPLANT SITE DID REQUIRE ASPIRATION DUE TO THE SEROMA/FLUID ACCUMULATION. REPORTEDLY, GORE-TEX® SUTURE WAS ALSO USED IN THE PROCEDURE. IT WAS REPORTED THE PHYSICIAN IS CONCERNED ABOUT THE PERFORMANCE OF THE MESH AND THE ADHESIONS, NOT SO MUCH THE SEROMA OR THE INFECTION. AFTER THE REVIEW AND PLACEMENT OF THE MESH IN THE RIGHT WAY, THE PHYSICIAN PROCEEDED TO TAKE A SAMPLE TO TEST FOR INFECTION. IT WAS REPORTED THE PHYSICIAN LEFT A 14 FRENCH BLAKE DRAIN IN BETWEEN THE MESH AND PERITONEUM, UNTIL HE HAS THE TEST RESULTS. AN ABDOMINAL BINDER WAS USED POSTOPERATIVELY TO CLOSE THE DEAD SPACE. REPORTEDLY, THE LAB RESULTS SHOWED NEGATIVE FOR INFECTION. IT WAS REPORTED THERE WAS NO PRE-EXISTING INFECTION IN THE FIELD OF TREATMENT OR AN IATROGENIC INJURY. REPORTEDLY, THE PATIENT IS STABLE AND GETTING BETTER WITH LOWER INFLAMMATORY RESPONSE. REPORTEDLY, "THE PHYSICIAN SAID HE USED LOCAL ANESTHESIA IN THE PORT SITES FOR THE LAPAROSC
Patient problems: Seroma
MAUDE report 19909634 ↗InjuryJul 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT SACROCOLPOPEXY HERNIA REPAIR ON (B)(6) 2009 WHEREBY A GORE® DUALMESH® 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: EROSION, INFECTED MESH, MESH REMOVAL, DEVELOPED COMPLICATIONS INCLUDING BLOOD CLOT POST-REVISION PROCEDURE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Erosion; No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 19690634 ↗InjuryJun 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2014 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2019 AND (B)(6) 2019, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: BOWEL, COLON, OR OMENTUM ADHESIONS TO MESH, SEROMA/ABSCESS, BOWELL OR COLON RESECTION, BOWEL, COLON OR OTHER ORGAN PERFORATION, WOUND TREATMENT/WOUND VAC FOR 90+ DAYS ON (B)(6)2 014 - INCISIONAL HERNIA REPAIRED WITH GORE DUAL MESH. ON (B)(6) 2019 - TAKEN TO EMERGENCY SURGERY FOR COLONIC PERFORATION, OLD MESH AND PORTIONS OF COLON REMOVED. MESH WAS DENSELY ADHERENT TO THE UNDERLYING VISCERA. DURING THE LYSIS OF ADHESIONS A RIGHT RETROPERITONEAL ABSCESS WAS NOTED BEHIND THE TERMINAL ILEUM. ON (B)(6) 2019 - END COLOSTOMY CREATION AND PARTIAL SKIN CLOSURE WITH PACKING.. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Abscess; Tissue Breakdown; Unspecified Infection
MAUDE report 19578309 ↗InjuryApr 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN AND LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2011 WHEREBY A GORE® DUALMESH® 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: ADHESION, INFECTED MESH, MESH REMOVAL, SEROMA, WOUND DÉBRIDEMENT, NECROSIS, ADHESIONS, JP DRAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Abscess; Unspecified Infection
MAUDE report 19163136 ↗InjuryDec 4, 2023Mechanical Problem; Migration; Mechanical Problem; Migration
THE FOLLOWING INFORMATION WAS OBTAINED FROM MEDICAL RECORDS. IMPLANT PROCEDURE: RIGHT THORACOTOMY FOR REPAIR OF CHEST WALL/INTERCOSTAL HERNIA AS WELL AS DIAPHRAGMATIC/UPPER ABDOMINAL WALL HERNIA WITH GORE-TEX PROSTHETIC. [IMPLANT: GORE® DUALMESH® BIOMATERIAL, 1DLMC07/(B)(6), 20CM X 30CM X 1MM THICK.] IMPLANT DATE: (B)(6) 2013 [HOSPITALIZATION DATES (B)(6) 2013]. PARTIAL EXPLANT PROCEDURE: (B)(6) MD. REDO RIGHT THORACOTOMY FOR COMPLEX REPAIR OF CHEST WALL AND INTERCOSTAL HERNIA, AS WELL AS UPPER ABDOMINAL WALL HERNIA WITH PROLENE MESH. [IMPLANT PROLENE] DAVID ALAN SPAIN, MD. REPAIR OF RIGHT CHEST WALL HERNIA WITH MESH. PLACATION OF RIGHT OBLIQUE MUSCLES WITH MESH. PARTIAL EXPLANT DATE: (B)(6) 2014 [HOSPITALIZATION DATES (B)(6) 2014]. IMPLANT #1: 6981-1. IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN DIAPHRAGMATIC / UPPER ABDOMINAL WALL HERNIA REPAIR ON (B)(6) 2013 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON OCTOBER 29, 2014, AN ADDITIONAL PROCEDURE OCCURRED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERIES, PAIN, ADHESIONS, BREAKAGE, MIGRATION, HERNIA RECURRENCE, REVISION. ADDITIONAL EVENT SPECIFIC INFOR
Patient problems: Hernia
MAUDE report 18258943 ↗InjuryNov 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN UMBILICAL HERNIA REPAIR ON (B)(6) 2012 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6), 2019, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVED DUE TO INFECTION. FISTULOUS TRACT TO THE MESH. DENSE ADHESIONS OF THE SMALL AND LARGE BOWEL CREATING OBSTRUCTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Abscess; Unspecified Infection
MAUDE report 18234291 ↗InjuryNov 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL, VENTRAL SUPRAUMBILICAL HERNIA REPAIR ON (B)(6) 2001 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. IF APPLICABLE: 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: RECURRENT HERNIA WITH ADHESIONS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Hernia
MAUDE report 18085714 ↗InjuryNov 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL, VENTRAL SUPRAUMBILICAL HERNIA REPAIR ON (B)(6) 2001 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. IF APPLICABLE: 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: RECURRENT HERNIA WITH ADHESIONS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Hernia
MAUDE report 18085700 ↗InjuryNov 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2009, WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. PATIENT UNDERWENT AN ADDITIONAL OPEN VENTRAL HERNIA ON (B)(6) 2009, WHEREBY A SECOND GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2009 AND (B)(6) 2012, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REVISED DUE TO RECURRENT VENTRAL HERNIA. DENSE ADHESIONS OF THE BOWEL TO THE MESH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Hernia
MAUDE report 18084983 ↗InjuryNov 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2009, WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. PATIENT UNDERWENT AN ADDITIONAL OPEN VENTRAL HERNIA ON (B)(6) 2009, WHEREBY A SECOND GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2009 AND (B)(6) 2012, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REVISED DUE TO RECURRENT VENTRAL HERNIA. DENSE ADHESIONS OF THE BOWEL TO THE MESH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Hernia
MAUDE report 18084980 ↗
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 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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