MAK-NV™ 00884450088791Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884450088791), received between Nov 17, 2019 and May 16, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionNov 17, 2019Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A NEPHROSTOMY TUBE PLACEMENT PROCEDURE, THE INTRODUCER WIRE DETACHED WITHIN THE PATIENT. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE DETACHED WIRE TIP FROM THE PATIENT WITH A VASCULAR SNARE DEVICE DUE TO THE ACCESS WIRE TIP LOCATION. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9333521 ↗
• MalfunctionNov 17, 2019Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, WHILE ATTEMPTING VASCULAR ACCESS, THE RADIOLOGIST WAS UNABLE TO ADVANCE THE ACCESS WIRE INTO THE PATIENT'S ARTERY. THE ACCESS SITE WAS ABANDONED. PRIOR TO DISCHARGE THE RADIOLOGIST ORDERED AN ULTRASOUND SCAN OF THE PRIMARY ACCESS SITE. THE ULTRASOUND STUDY DEMONSTRATED THAT A PIECE OF THE ACCESS WIRE MAY HAVE DETACHED WITHIN THE PATIENTS RIGHT FEMORAL ARTERY. THE RADIOLOGIST INFORMED THE PATIENT AND FAMILY OF THE SITUATION AND CONSULTED WITH OTHER VASCULAR SURGEONS ABOUT LEAVING THE UNIDENTIFIED FOREIGN BODY WITHIN THE PATIENT'S ARTERY. DUE TO THE FACT THE ARTERY WAS ALREADY OCCLUDED, THE FOREIGN BODY COULD NOT CAUSE PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9333517 ↗