MAK-NVRecalls & reported problems across all models
Merit Medical Systems, Inc. · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls
- 0
We found 11 models of MAK-NV by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Oct 25, 2019 and Jan 7, 2026 — classified as 14 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Fracture” (19 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported MAK-NV problems
Device problems
- Fracture19
- Material Separation17
- Break5
- Material Integrity Problem2
- Obstruction of Flow2
- Difficult to Advance1
- Difficult to Remove1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Foreign Body In Patient9
- No Known Impact Or Consequence To Patient1
MAK-NV models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MAK-NV™ 00884450013588NEEDLE, CATHETER6 reports
- MAK-NV™ 00884450088791NEEDLE, CATHETER5 reports
- MAK-NV™ 00884450088838NEEDLE, CATHETER4 reports
- MAK-NV™ 00884450013564NEEDLE, CATHETER2 reports
- MAK-NV™ 00884450013571NEEDLE, CATHETER2 reports
- MAK-NV™ 00884450088876NEEDLE, CATHETER2 reports
- MAK-NV™ 00884450013601NEEDLE, CATHETER1 report
- MAK-NV™ 00884450088807NEEDLE, CATHETER1 report
- MAK-NV™ 00884450088821NEEDLE, CATHETER1 report
- MAK-NV™ 00884450088845NEEDLE, CATHETER1 report
- MAK-NV™ CNEEDLE, CATHETER1 report
Recent MAK-NV adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2026Difficult to Remove; Difficult to Advance
THE ACCOUNT ALLEGES THAT WHILE ADVANCING THE DILATOR SHEATH OVER THE GUIDEWIRE, RESISTANCE WAS ENCOUNTERED, AND THE SHEATH COULD NEITHER BE ADVANCED NOR WITHDRAWN. BOTH THE GUIDEWIRE AND SHEATH WERE THEN REMOVED TOGETHER, REVEALING THAT THE GUIDEWIRE SURFACE WAS FRAYED, LIKELY DUE TO RELATIVE CUTTING INTERACTION WITH THE PUNCTURE NEEDLE, RESULTING IN A SIGNIFICANT SEGMENT OF DEFORMATION. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23995541 ↗InjuryJul 16, 2025Break; Fracture; Material Separation; Material Integrity Problem; Break; Fracture; Material Separation; Material Integrity Problem
THE ACCOUNT ALLEGES THAT DURING A PYELOSTOMY PROCEDURE, THE THIN NITINOL GUIDE WIRE BROKE AND THE TIP REMAINED IN THE PATIENT'S KIDNEY. THE DETACHED PIECE WAS REMOVED WITH A FOREIGN OBJECT REMOVAL SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22521302 ↗MalfunctionJul 16, 2025Break; Fracture; Material Separation; Material Integrity Problem; Break; Fracture; Material Separation; Material Integrity Problem
THE ACCOUNT ALLEGES THAT WHEN THEY PULLED THE NITINOL WIRE OUT OF THE CASING FROM THE DEVICE PACKAGE, IT WAS SPLIT AT ONE POINT, AND IT WAS NOT SMOOTH AND STRAIGHT. IT WAS CROOKED AND APPEARED THAT THE BRAIDING BECAME UNRAVELED. NO PATIENT INJURY OR INTERACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22521298 ↗MalfunctionJun 18, 2025Break; Break
THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE, THE CATHETER TIP DETACHED AND WAS LEFT IN THE BODY. IT IS UNKNOWN IF THE TIP HAS BEEN REMOVED AT THIS TIME.
Patient problems: Foreign Body In Patient
MAUDE report 22286377 ↗InjuryMay 16, 2025Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING A PROCEDURE, A 6 FR MAK-NV WIRE WAS USED AND THE TIP SPLIT AND DETACHED INTO 2 DIFFERENT PIECES INSIDE THE PATIENT'S KIDNEY. BOTH PIECES WERE SUCCESSFULLY RETRIEVED BY THE SURGEON AND AN X-RAY CONFIRMED NO WIRE WERE LEFT BEHIND. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22033381 ↗MalfunctionApr 7, 2025Material Split, Cut or Torn
A 6 FR MAKNV WIRE WAS USED AND THE TIP SPLIT INTO 2 DIFFERENT PIECES INSIDE THE PATIENT'S KIDNEY, BOTH PIECES WERE RETRIEVED BY SURGEON AND X-RAY WAS TAKEN TO CONFIRM NO WIRE WAS LEFT BEHIND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21786953 ↗InjuryApr 1, 2025Obstruction of Flow; Obstruction of Flow
THE ACCOUNT ALLEGES THAT WHEN INSERTING THE 0.018" GUIDE WIRE THROUGH THE 21G NEEDLE IT BECAME STUCK. NO MEDICAL INTERVENTION WAS DEEMED NECESSARY AND NO FOREIGN BODY INTRODUCTION OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21746093 ↗InjuryApr 1, 2025Obstruction of Flow; Obstruction of Flow
THE ACCOUNT ALLEGES THAT WHEN INSERTING THE 0.018" GUIDE WIRE THROUGH THE 21G NEEDLE IT BECAME STUCK. NO MEDICAL INTERVENTION WAS DEEMED NECESSARY AND NO FOREIGN BODY INTRODUCTION OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21745888 ↗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 ↗InjuryNov 22, 2024Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING AN INTERVENTIONAL RADIOLOGY INSERTION PROCEDURE, THE MINI ACCESS GUIDEWIRE DETACHED DURING MANIPULATION WITHIN THE PATIENT'S KIDNEY. THE FOREIGN BODY WAS FREE FLOATING IN THE RENAL PELVIS / CALYCES AT THE TIME OF REMOVAL. IT WAS CLINICALLY NECESSARY TO REMOVE THE FOREIGN BODY FROM THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20765350 ↗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 ↗MalfunctionJan 9, 2024Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING A BILE DUCT CATHETERIZATION PROCEDURE, THE PLATINUM TIP OF A MICRO ACCESS GUIDE WIRE DETACHED WITHIN A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18477873 ↗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 ↗InjuryOct 4, 2023Material Deformation; Material Deformation
THE ACCOUNT ALLEGES THAT WHILE ACCESSING THE BILE DUCT OF THE PATIENT THE CORE OF THE WIRE FRAYED. THE CLINICIAN NOTICED THE FRAYED WIRE IMMEDIATELY AND BEGAN REMOVING IT. THE ENTIRE WIRE WAS REMOVED FROM THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17870347 ↗InjuryJun 6, 2023Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT WHILE PLACING A NEPHROSTOMY TUBE, THE GUIDEWIRE (2CM PIECE) DETACHED WITHIN THE PATIENT ANATOMY. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM AND THE FOREIGN BODY WAS SUCCESSFULLY REMOVED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17076195 ↗
Other Merit Medical Systems, Inc. products
- Aspira11 models · 36 reports · 10 recalls
- Impress145 models · 481 reports
- Monarch6 models · 37 reports · 7 recalls
- Bridge Prep Kit4 models · 6 reports · 3 recalls
- Prelude Roadster33 models · 1 reports · 3 recalls
- basixTOUCH6 models · 1 reports · 3 recalls
- basixCOMPAK34 models · 34 reports · 2 recalls
- Flex-Neck11 models · 21 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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