NanoCross™ Elite AB14W025120150Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000109684), received between Apr 12, 2019 and Feb 18, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K141118); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2025Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  A PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON WAS INTENDED TO BE USE USED FOR THE TREATMENT OF A FIBROUS/PLAQUE LESION WITH 70% STENOSIS IN THE MID/DISTAL REGION OF THE LEFT PERONEAL ARTERY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE BALLOON WAS INFLATED WITH A SYRINGE, INFLATION FLUID WAS USED. NO LEAKS NOTED ON THE DEVICE. IT WAS REPORTED DURING BALLOON INFLATION AT 12ATM BALLOON INFLATION DIFFICULTIES WERE MET, BALLOON COULD NOT BE INFLATED. THE DEVICE HAD NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS MET WHEN ADVANCING THE DEVICE. ANOTHER BALLOON OF THE SAME MODEL WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY. WHEN THE DEVICE WAS RECEIVED FOR EVALUATION, IT WAS NOTED THAT THE THERE WAS A LEAK IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21400068 ↗
• InjuryDec 15, 2021Burst Container or Vessel; Entrapment of Device; Difficult to Remove; Difficult to Advance; Burst Container or Vessel; Entrapment of Device; Difficult to Remove; Difficult to Advance

  PHYSICIAN WAS ATTEMPTING TO USE THE NANOCROSS BALLOON CATHETER DURING PROCEDURE TO TREAT SEVERELY CALCIFIED LESION IN THE MID AND PROXIMAL RIGHT TIBIAL/POPLITEAL TRUNK (TPT) AND PERONEAL ARTERY. THE VESSEL HAD NO TORTUOSITY AND EXHIBITED 80% STENOSIS. THE ARTERY DIAMETER WAS 2.5MM AND LESION LENGTH WAS 40-50MM. A NON-MEDTRONIC 7FR SHEATH AND NON-MEDTRONIC 0.014'' GUIDEWIRE WERE USED. THE BALLOON WAS INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE. INFLATION FLUID OF 50-50 CONTRAST AND SALINE WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES. THE BALLOON DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. THERE WAS NO STENT PRESENT IN THE VESSEL BED IN THE PATIENT'S RIGHT LEG. IT WAS REPORTED THAT GUIDEWIRE LOCK-UP OCCURRED DURING PROCEDURE IN TANDEM WITH A LONGITUDINAL BALLOON BURST AT 8ATM. THE BALLOON WAS USED TO DILATE A CTO ANTERIOR TIBIAL ARTERY MULTIPLE TIMES SUCCESSFULLY AND WHEN REDIRECTED TO TIBIAL PERONEAL TRUNK ARTERY THE BALLOON RUPTURED ON FIRST INFLATION. ALL FRAGMENTS WERE NOT RETRIEVED. THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO RETRIEVE REMAINING PARTS OF BALLOON(D

  Patient problems: Device Embedded In Tissue or Plaque; Obstruction/Occlusion

  MAUDE report 13008948 ↗
• InjuryApr 12, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PATIENT HAD A SURGICAL PROCEDURE DURING WHICH A NANOCROSS 2.5MMX120MM BALLOON RUPTURED DURING INFLATION AND UPON REMOVAL. THE DISTAL MARKER DID NOT COME OUT WITH THE BALLOON.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8508235 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141118. One submission often covers many models, so check the product and lot details in each record.

• Z-0904-2025 · Dec 10, 2024 · Open, Classified
  Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090,