MAK-NV™ 00884450088821Recalls & reported problems
Merit Medical Systems, Inc. · Class 1
- 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 00884450088821), received between Oct 25, 2023 and Oct 25, 2023 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
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.
InjuryOct 25, 2023Fracture; Fracture
THE ACCOUNT ALLEGES THAT DURING ACCESS FOR NEPHROSTOMY CATHETER PLACEMENT, A PUNCTURE OF THE RENAL PELVIS WAS PERFORMED WITH A MICROPUNCTURE SET. THE ACCESS PROCEDURE WAS COMPLICATED FOR THE CLINICIAN. THE MICRO-MANDREL ACCESS WIRE WAS PASSED THROUGH THE MICRONEEDLE DOWN INTO THE URETHRA. THE NEEDLE WAS THEN REMOVED, AND THE ACCOMPANYING CATHETER WAS PASSED OVER THE MANDREL/MICROWIRE. IT WAS THEN OBSERVED THAT THE SOFT PART OF THE ACCESS MICRO-WIRE TIP (DISTAL END) HAD DETACHED WITHIN THE PATIENT'S URETHRA. NOT MUCH MANIPULATION OF THE WIRE [MANDIBLE] WAS PERFORMED. THE DETACHED TIP WAS REMOVED WITH A SNARE DEVICE. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18007975 ↗
Other NEEDLE, CATHETER devices
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- 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.