Merit MAK™ 00884450012598Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of Merit MAK (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450012598), received between Mar 13, 2020 and Jul 27, 2022 — classified as 1 injury, 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 18, 2026.
Most reported problems
Device problems
- Fracture2
- Material Separation2
- Physical Resistance/Sticking1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2022Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING PROCEDURE, WHILE THE SHEATH WAS REMOVED IT BROKE AND DISCONNECTED IN PATIENT BODY. THE BROKEN SHEATH WAS REMOVED WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15114738 ↗MalfunctionDec 8, 2021Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT WHILE USING FLUOROSCOPY, THE TIP OF THE GUIDEWIRE WAS DETACHED DURING INSERTION INTO THE VEIN WITH ECHO-GUIDE. RESISTANCE WAS FELT, AND THE TIP DETACHED WITHIN THE HYPODERMAL TISSUE. THE TIP WAS REMOVED FROM THE PATIENT'S BODY. NO INJURY TO REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 12961460 ↗MalfunctionMar 13, 2020Physical Resistance/Sticking
ELDERLY FEMALE WITH HISTORY OF CORONARY ARTERY DISEASE, ELEVATED CHOLESTEROL AND ASTHMA. DURING THE PROCEDURE- TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR), THE WIRE GOT STUCK IN THE MINI STICK SHEATH ACCESS AND HAD TO BE REMOVED. ACCESS HAD TO BE REGAINED, WITHOUT KNOWN HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9828861 ↗
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- Mini Stick MAX H965457510Angiodynamics, Inc. · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall1 report
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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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