GORE MYCROMESH PLUS Biomaterial 1MYMP06Recalls & reported problems
W. L. Gore & Associates, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132601646), received between May 2, 2025 and May 2, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Biocompatibility” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Biocompatibility1
- Device Dislodged or Dislocated1
Patient problems
- Abdominal Pain1
- Abscess1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Foreign Body Reaction1
- Granuloma1
- Hernia1
- Necrosis1
- Obstruction/Occlusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 2, 2025Biocompatibility; Device Dislodged or Dislocated; Biocompatibility; Device Dislodged or Dislocated
IT WAS REPORTED TO GORE THAT A PATIENT RECEIVED A GORE® MYCROMESH® PLUS BIOMATERIAL TO REPAIR MUSCLES TORN DURING SPORTING ACTIVITIES, WHICH RESULTED IN UMBILICAL AND INGUINAL HERNIAS BEING REPAIRED SOMETIME IN 2008. APPROXIMATELY A YEAR AFTER THE SURGERY, THE PATIENT REPORTEDLY BEGAN EXPERIENCING OCCASIONAL SUBTLE PAINS, WHICH BECAME MORE FREQUENT AND SEVERE TOWARDS THE END OF 2022. IN (B)(6) 2022, THE PAIN ALLEGEDLY BECAME EXCRUCIATING, LEADING TO AN EMERGENCY ROOM VISIT WHERE A SCAN REVEALED THE MESH HAD INFILTRATED AND INTEGRATED INTO THE INTESTINAL TISSUE, NECESSITATING IMMEDIATE REMOVAL SURGERY. ADDITIONAL SURGERIES WERE REPORTEDLY PROMPTED BY THE DISCOVERY OF THE MASS ON ANOTHER HERNIA DURING THE INITIAL DEVICE REMOVAL PROCEDURE WHICH LED TO TWO ADDITIONAL SURGERIES IN 2023. REPORTEDLY, THE MESH FORMED A MASS AROUND A BLOOD VESSEL, WHICH LED TO THE REMOVAL OF A TESTICLE AND PARTIAL INTESTINE. THE PATIENT TOLERATED THE PROCEDURES AND REPORTS TO BE PAIN FREE AFTER THE DEVICE REMOVAL.
Patient problems: Abdominal Pain; Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Granuloma; Hernia; Necrosis; Obstruction/Occlusion; Tissue Breakdown
MAUDE report 21955548 ↗
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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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