MAK-NV™ 00884450013564Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450013564), received between Apr 11, 2023 and Mar 19, 2025 — classified as 1 injury, 1 malfunction.
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
- Break1
- Material Separation1
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.
MalfunctionMar 19, 2025Break; Fracture; Break; Fracture
THE ACCOUNT ALLEGES THAT UPON REMOVAL FROM THE PATIENT THE FLOPPY END OF THE MANDREL WIRE SHEARED OFF AND WAS LEFT IN THE PATIENT'S BILE DUCT.
Patient problems: Foreign Body In Patient
MAUDE report 21644407 ↗InjuryApr 11, 2023Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT POST NEPHROSTOMY TUBE PLACEMENT PROCEDURE, THE TIP OF THE ACCESS GUIDEWIRE WAS MISSING. THE PHYSICIAN WAS UNSUCCESSFUL IN RETRIEVING THE FOREIGN BODY FROM THE PATIENT. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM FOR SURGICAL INTERVENTION RESULTING IN THE SUCCESSFUL REMOVAL OF THE FOREIGN BODY. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 16717136 ↗
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.
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