MAK-NV™ 00884450088838Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450088838), received between Oct 25, 2019 and Jul 16, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryMay 2, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT WHEN ATTEMPTING TO MANEUVER AROUND A KIDNEY STONE. THE FRONT END OF THE CATHETER NEAR THE RADIOPAQUE MARKER DETACHED. THE DEVICE REMAINED ON THE GUIDEWIRE AND WAS RETRIEVED ALONG WITH THE GUIDEWIRE. NO ADDITIONAL INTERVENTION PROCEDURE WAS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16856474 ↗
• InjuryMar 6, 2020Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS NEPHROSTOMY TUBE PLACEMENT PROCEDURE ON AN ELDERLY FEMALE PATIENT, A MICROPUNCTURE ACCESS GUIDEWIRE TIP DETACHED. THE PHYSICIAN WAS ATTEMPTING NON-VASCULAR ACCESS WITH ECO/FLUOROSCOPIC GUIDANCE AT THE LOWER CALYX OF THE KIDNEY. DURING WIRE MANIPULATIONS THROUGH AN ACCESS NEEDLE, 4CM OF THE DISTAL 0.018 GUIDEWIRE DETACHED. THE DETACHED FRAGMENT OF THE NON-VASCULAR ACCESS WIRE REMAINS WITHIN THE PATIENT'S KIDNEY. A POST-PROCEDURAL COMPUTED TOMOGRAPHY [CT] SCAN WAS PERFORMED. CONSIDERING THE HEALTH CONDITIONS OF THE PATIENT AND THE EXISTING COMORBIDITIES, THE MEDICAL STAFF DECIDED NOT TO ATTEMPT TO RETRIEVE THE FOREIGN BODY FRAGMENT FROM THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9799391 ↗
• InjuryOct 25, 2019Break; Fracture; Material Separation; Break; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A NEPHROSTOMY STENT IMPLANT PROCEDURE, THE ACCESS WIRE TIP DETACHED WITHIN THE PATIENTS LEFT INFERIOR RENAL POLE DURING WIRE MANIPULATIONS. THE PHYSICIAN WAS UNSUCCESSFUL IN RETRIEVING THE WIRE TIP WITH A VASCULAR SNARE. PROLONGATION OF HOSPITALIZATION WAS NECESSARY FOR CONTINUED OBSERVATION. THE PHYSICIAN STATES THAT A SMALL PIECE OF THE WIRE WAS LEFT WITHIN THE PATIENT'S RENAL COLLECTION SYSTEM. THE PATIENT WAS DISCHARGED TO HOME AND SCHEDULED FOR A FOLLOW UP APPOINTMENT AND POSSIBLE INTERVENTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 9242430 ↗