MAK-NV™ 00884450013601Recalls & 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
- 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 00884450013601), received between Apr 3, 2020 and Apr 3, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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 18, 2026.
Most reported problems
Device problems
- Fracture1
- Material Separation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2020Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING BILE DUCT ACCESS UNDER FLUOROSCOPY WITH A MICROPUNCTURE ACCESS KIT, THE TIP OF THE ACCESS WIRE UNRAVELED AND DETACHED WITHIN THE INTRAHEPATIC BILE DUCT OF THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 9920865 ↗
Other NEEDLE, CATHETER devices
- Cook G09490Cook Incorporated · NEEDLE, CATHETER1 recall9 reports
- Cook G09492Cook Incorporated · NEEDLE, CATHETER7 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page