MAK-NV™ CRecalls & reported problems
Merit Medical Systems, Inc. · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450820612), received between Jan 7, 2026 and Jan 7, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Advance1
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2026Difficult to Remove; Difficult to Advance
THE ACCOUNT ALLEGES THAT WHILE ADVANCING THE DILATOR SHEATH OVER THE GUIDEWIRE, RESISTANCE WAS ENCOUNTERED, AND THE SHEATH COULD NEITHER BE ADVANCED NOR WITHDRAWN. BOTH THE GUIDEWIRE AND SHEATH WERE THEN REMOVED TOGETHER, REVEALING THAT THE GUIDEWIRE SURFACE WAS FRAYED, LIKELY DUE TO RELATIVE CUTTING INTERACTION WITH THE PUNCTURE NEEDLE, RESULTING IN A SIGNIFICANT SEGMENT OF DEFORMATION. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23995541 ↗
Other NEEDLE, CATHETER devices
- Cook G09490Cook Incorporated · NEEDLE, CATHETER1 recall9 reports
- Cook G10100Cook Incorporated · NEEDLE, CATHETER7 reports
- Cook G09492Cook Incorporated · NEEDLE, CATHETER7 reports
- MAK-NV™ 00884450013588Merit Medical Systems, Inc. · NEEDLE, CATHETER6 reports
- Cook G09489Cook Incorporated · NEEDLE, CATHETER5 reports
- MAK-NV™ 00884450088791Merit Medical Systems, Inc. · NEEDLE, CATHETER5 reports
- Ring G03388Cook Incorporated · NEEDLE, CATHETER5 reports
- Skater™ Introducer System 651506300Argon Medical Devices, Inc. · Needle, Catheter5 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.