Merit MAK™ 00884450011454Recalls & 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
- 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 00884450011454), received between Jun 25, 2024 and Dec 4, 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Material Separation2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2025Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING A FEMORAL ANGIOGRAM PROCEDURE THE DEVICE SEPARATED FROM THE HUB. WHEN THE PROVIDER TWISTED THE SYRINGE ONTO THE HUB OF THE MICROPUNCTURE SHEATH, IT DETACHED FROM THE SHEATH AND LEFT THE SHAFT INSIDE THE VESSEL. THE PATIENT HAD TO BE TAKEN TO VASCULAR SURGERY FOR SHEATH REMOVAL.
Patient problems: Foreign Body In Patient
MAUDE report 23720198 ↗MalfunctionJun 25, 2024Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT THE TIP OF AN ACCESS WIRE DISLODGED WITHIN A PATIENTS VESSEL DURING ACCESS FOR HD CATHETER PLACEMENT. THE ACCESS WIRE DETACHED AND IS CURRENTLY WEDGED WITHIN THE PATIENT'S ADIPOSE TISSUE. THE PHYSICIAN IS NOT CONCERNED ABOUT POSSIBLE IATROGENIC FOREIGN BODY [IFB] MIGRATION OR EMBOLISM. THERE ARE NO PLANS TO REMOVE THE EMBEDDED IFB FROM THIS PATIENT. THE TIP OF THE ACCESS WIRE IS STERILE ENCAPSULATE.
Patient problems: Foreign Body In Patient
MAUDE report 19609853 ↗
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- TightRail Rotating Dilator Sheath 545-513Spectranetics Corporation · Dilator, Vessel, For Percutaneous Catheterization20 deaths74 reports
- VersaCross Connect LAAC Access Solution VXAK0003Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization2 deaths70 reports
- VersaCross Connect LAAC Access Solution VXAK0007Baylis Médicale Cie Inc · Dilator, Vessel, For Percutaneous Catheterization2 deaths54 reports
- AVANTI 504656XCordis Corporation · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall2 reports
- Mini Stick MAX H965457510Angiodynamics, Inc. · DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION1 recall1 report
- Abiomed® 00884450732311Merit Medical Systems, Inc. · Dilator, Vessel, For Percutaneous Catheterization1 recall1 report
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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