Duramesh MSI-501Recalls & reported problems
Mesh Suture Inc. · DURAMESH™ 2 Mesh Suture: Large Needle – USA · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850008298134), received between Jul 10, 2025 and Jul 10, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
Patient problems
- Wound Dehiscence1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
A REVIEW OF THE SURGEON'S REPORT INDICATES THAT AFTER USING DURAMESH MSI-5015 / LOT #F404GFR ON A SURGERY PERFORMED (B)(6) 2025 THE PATIENT WAS OBSERVED ON (B)(6) 2025 TO REQUIRE POST-SURGICAL INTERVENTION. THE PATIENT WAS ADMITTED FOR AN END ILEOSTOMY TAKEDOWN PROCEDURE AND FASCIAL CLOSURE WITH DURAMESH. THE KNOTS APPEARED TO COME UNSECURED POST-SURGERY. NUMBER OF PATIENTS: 1
Patient problems: Wound Dehiscence
MAUDE report 22472418 ↗
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- PROLENE 8711HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 recall89 reports
- PROLENE 9702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE130 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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