Duramesh MSI-200Recalls & reported problems
Mesh Suture Inc. · DURAMESH™ 0 Mesh Suture: Small Needle – USA · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850008298080), received between Dec 17, 2023 and Mar 30, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method2
Patient problems
- Wound Dehiscence2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026Improper or Incorrect Procedure or Method
MIDLINE AND OSTOMY SITE HERNIAS, CDC 1 CASE. THE SIZE O DURAMESH WAS USED TO CLOSE THE OSTOMY SITE. THERE WAS A MESH UNDERNEATH IT. AT 4 HOURS AFTER SURGERY, THE PATIENT WAS NOTED TO HAVE BLEEDING IN THE DRAINS. HE WAS TAKEN BACK TO SURGERY, WHERE A HEMATOMA AT THE OSTOMY SITE WAS NOTED. THE DURAMESH O WAS FOUND TO BE IN TWO PIECES, WITH INTACT KNOTS AT EITHER END. THE DIVIDED DURAMESH SIZE O MAY HAVE LED TO TISSUE TEARING AND THE HEMATOMA. THE PATIENT HAD THE HEMATOMA EVACUATED, AND THE AREA WAS CLOSED WITH ANOTHER DURAMESH 0. HE IS FINE ON HIS POSTOPERATIVE VISIT AT 1 WEEK NUMBER OF PATIENTS: 1.
Patient problems: Wound Dehiscence
MAUDE report 24723561 ↗MalfunctionDec 17, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
A REVIEW OF THE SURGEON'S REPORT INDICATES THAT AFTER USING DURAMESH MSI-2005 / LOT #CB04PYU ON A SURGERY PERFORMED (B)(6) 2023 THE PATIENT WAS OBSERVED ON (B)(6) 2023 TO REQUIRE POST-SURGICAL INTERVENTION. THE PATIENT WAS ORIGINALLY ADMITTED FOR A RECURRENT UMBILICAL HERNIA MEASURING 5CM. THE DEFECT WAS REPAIRED USING DURAMESH USING A INTERMITTENT FIGURE-8 CLOSURE TECHNIQUE WITH KNOTS TIED AT THE END OF EACH INTERMITTENT STITCH. THE KNOTS APPEARED TO COME UNSECURED POST-SURGERY. NUMBER OF PATIENTS: 1.
Patient problems: Wound Dehiscence
MAUDE report 18342255 ↗
Other Suture, Nonabsorbable, Synthetic, Polypropylene devices
- PROLENE 8706HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE2 recalls294 reports
- PROLENE 8702HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 deaths254 reports
- PROLENE 8556HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death240 reports
- PROLENE 8805HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE1 death209 reports
- PROLENE 8521HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE3 deaths183 reports
- PROLENE 8735HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE163 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page