GORE MYCROMESH Biomaterial 1MYM18Recalls & reported problems
W. L. Gore & Associates, Inc. · Class 2 · Implant
All models of GORE MYCROMESH Biomaterial (7)
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 00733132601608), received between Sep 10, 2019 and Oct 16, 2019 — 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 Conditions2
- No Code Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCARCERATED UMBILICAL HERNIA REPAIR ON (B)(6) 2005, WHEREBY A GORE® MYCROMESH® 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: THE HERNIA SAC WAS DEBRIDED WITH THE MESH, PARTIAL MESH REMOVAL REQUIRING AN ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available
MAUDE report 9197089 ↗InjurySep 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INGUINAL HERNIA REPAIR ON (B)(6) 2013 WHEREBY A GORE® MYCROMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT AN ADDITIONAL PROCEDURE OCCURRED; HOWEVER, THE DATE OF SURGERY IS CURRENTLY UNKNOWN. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REVISION RESULTING IN AN ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available
MAUDE report 8979427 ↗
Other Mesh, Surgical, Polymeric devices
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- PROCEED PCDG1Johnson & Johnson International Inc. · Mesh, surgical, polymeric1 recall1 death637 reports
- PROCEED PVPSJohnson & Johnson International Inc. · Mesh, surgical, polymeric622 reports
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- 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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