Merit MAK™ 00884450012840Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450012840), received between Dec 11, 2024 and Nov 25, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Fracture1
- Material Frayed1
Patient problems
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 25, 2025Material Frayed; Material Frayed
CUSTOMER REPORTS DURING A CARDIAC CATH-LAB PROCEDURE, A MICRO PUNCTURE WIRE WAS INSERTED INTO THE PATIENT. UPON REMOVAL, THE WIRE BEGAN TO "FRAY"- THE PATIENT WAS EXAMINED UNDER X-RAY TO MAKE SURE NO PIECES OF THE WIRE REMAINED IN THE PATIENT'S BODY. NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23645276 ↗InjuryJan 8, 2025Fracture; Fracture
THE ACCOUNT ALLEGES THAT THE TIP OF THE WIRE BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN WAS ABLE TO SNARE IT OUT.
Patient problems: Foreign Body In Patient
MAUDE report 21102930 ↗InjuryDec 11, 2024Break; Break
CUSTOMER ALLEGES THAT THE WIRE TIP SHEARED OFF DURING VASCULAR ACCESS.
Patient problems: Foreign Body In Patient
MAUDE report 20904005 ↗
Other DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION devices
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- TandemLife 5740-2417Cardiacassist, Inc. · Dilator, Vessel, For Percutaneous Catheterization2 recalls0 reports
- 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
- Abiomed® 00884450732311Merit Medical Systems, Inc. · Dilator, Vessel, For Percutaneous Catheterization1 recall1 report
- Mini Stick MAX H965457510Angiodynamics, 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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