MAK-NV™ 00884450088845Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450088845), received between Aug 12, 2021 and Aug 12, 2021 — classified as 1 injury.
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
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.
InjuryAug 12, 2021Fracture; Fracture
THE ACCOUNT ALLEGES THAT DURING A NEPHROSTOMY PROCEDURE, THE ACCESS WIRE TIP FROM THE MICROPUNCTURE KIT DETACHED WITHIN THE PATIENT. THE PHYSICIAN ATTEMPTED TO REMOVE THE FOREIGN BODY BUT WAS UNSUCCESSFUL. PHYSICIAN WAS NOT CONCERNED ABOUT MIGRATION DUE TO FOREIGN BODY ENTRAPMENT WITHIN THE RENAL CORTEX. A NEW DEVICE WAS USED TO SUCCESSFULLY COMPLETE THIS PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12313279 ↗
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