GORE DUALMESH Biomaterial 1DLMC202Recalls & reported problems
W. L. Gore & Associates, Inc. · GORE DUALMESH BIOMATERIAL 18.0cmX24.0cmX2.0mm · Class 2 · Implant
All models of GORE DUALMESH Biomaterial (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132601059), received between Aug 20, 2019 and Oct 10, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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
Device problems
- Insufficient Device Problem Information2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Information1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 10, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL UMBILICAL HERNIA REPAIR ON (B)(6) 2001 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2002, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERY; ADHESIONS; MESH MIGRATION; MESH REMOVAL; RECURRENCE; WOUND DEBRIDEMENT; INFECTION; SEVERE COUGHING; FISTULA; SKIN NECROSIS; PAIN & SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Unspecified Infection
MAUDE report 15573679 ↗InjuryAug 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN UMBILICAL HERNIA REPAIR ON (B)(6) 2011, WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: "MESH FAILURE, ADDITIONAL REVISION SURGERY ON (B)(6) 2011". ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Information
MAUDE report 8913024 ↗
Other Mesh, Surgical, Polymeric devices
- PROCEED PVPMJohnson & Johnson International Inc. · Mesh, surgical, polymeric1,233 reports
- PROCEED PCDN1Johnson & Johnson International Inc. · Mesh, surgical, polymeric744 reports
- PROCEED PCDG1Johnson & Johnson International Inc. · Mesh, surgical, polymeric1 recall1 death637 reports
- PROCEED PVPSJohnson & Johnson International Inc. · Mesh, surgical, polymeric622 reports
- ProGrip LPG1510Sofradim Production · Mesh, surgical, polymeric2 deaths616 reports
- VENTRALEX 0010302Davol Inc. · Mesh, surgical, polymeric4 deaths531 reports
- BARD 0112680Davol Inc. · Mesh, surgical, polymeric1 death494 reports
- ProGrip TEM1509GSofradim Production · Mesh, surgical, polymeric3 deaths471 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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