Merit MAK™Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of Merit MAK (12)
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 00884450860311), received between Sep 16, 2025 and Sep 16, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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
- Fracture2
- Material Separation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2025Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THEY ARE EXPERIENCING ISSUES WITH THE GUIDEWIRES UNRAVELLING WHILE INSIDE OF THE PATIENT. THE WIRE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23068106 ↗MalfunctionSep 16, 2025Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THEY ARE EXPERIENCING ISSUES WITH THE GUIDEWIRES UNRAVELLING WHILE INSIDE OF THE PATIENT. THE WIRE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23068104 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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