GORE MYCROMESH Biomaterial 1MYM07Recalls & 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 00733132601530), received between Sep 25, 2019 and Oct 7, 2020 — 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
- Fistula1
- Insufficient Information1
- No Information1
- Obstruction/Occlusion1
- 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 7, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN UMBILICAL HERNIA REPAIR ON (B)(6) 2007 WHEREBY A GORE® MYCROMESH® 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: CONTINUED DRAINAGE, ADDITIONAL SURGERIES, FOREIGN BODY RESPONSE, FISTULA, ABDOMINAL WALL RECONSTRUCTION, ADHESIONS, SURGERY TO REMOVE MESH, PARTIAL SMALL BOWEL OBSTRUCTION, ADHESIONS TO SMALL INTESTINE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Fistula; Obstruction/Occlusion; Unspecified Infection
MAUDE report 10643522 ↗InjurySep 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2001 WHEREBY A GORE® DUALMESH® BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON AN UNKNOWN DATE, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVED REQUIRING AN ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: Insufficient Information; No Information
MAUDE report 9119412 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page