MAK-NV™ 00884450013588Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884450013588), received between Aug 23, 2022 and Jul 16, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 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 ↗
• 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 ↗
• MalfunctionAug 23, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE A PIECE OF THE GUIDE WIRE BROKE OFF WITHIN THE PATIENT. A RETRIEVAL WAS ATTEMPTED THROUGH CT AND A CUT DOWN, BUT WAS UNSUCCESSFUL. ANOTHER ATTEMPT AT RETRIEVAL OF THE FOREIGN BODY WILL BE MADE USING AN ENDOSCOPE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15279931 ↗