MAK-NV™ 00884450013571Recalls & reported problems
Merit Medical Systems, Inc. · Class 1
All models of MAK-NV (11)
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 00884450013571), received between Oct 21, 2021 and Jan 9, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation2
- Fracture1
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.
MalfunctionJan 9, 2024Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS NEPHROSTOMY PROCEDURE THE TIP OF THE ACCESS WIRE DETACHED WITHIN A PATIENT. NO RISK OF MIGRATION. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18477874 ↗MalfunctionOct 21, 2021Material Separation; Material Separation
THE ACCOUNT ALLEGES THAT THE CLINICIAN EXPERIENCED ACCESS RELATED COMPLICATIONS WHILE ATTEMPTING TO ACQUIRE VASCULAR ACCESS FOR A THORACENTESIS PLACEMENT PROCEDURE WHEN THE DISTAL ACCESS WIRE TIP WAS ACCIDENTALLY SHEARED OFF WITHIN THE PATIENT'S CHEST. THE FOREIGN BODY WAS EXTERNALIZED, AND THE CHEST TUBE WAS SUCCESSFULLY PLACED WITHOUT ANY ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12676129 ↗
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- Cook G10100Cook Incorporated · NEEDLE, CATHETER7 reports
- MAK-NV™ 00884450013588Merit Medical Systems, Inc. · NEEDLE, CATHETER6 reports
- Ring G03388Cook Incorporated · NEEDLE, CATHETER5 reports
- Cook G09489Cook Incorporated · NEEDLE, CATHETER5 reports
- Skater™ Introducer System 651506300Argon Medical Devices, Inc. · Needle, Catheter5 reports
- MAK-NV™ 00884450088791Merit Medical Systems, Inc. · NEEDLE, CATHETER5 reports
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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