NanoCross™ Elite AB14W035080150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000109967), received between Jul 9, 2019 and Mar 30, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2021Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS PTA BALLOON WITH A 6FR SHEATH AND 0.014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A CALCIFIED AND PLAQUE 80MM LESION IN THE PATIENT¿S MID RIGHT TIBIAL/POPLITEAL TRUNK AND ANTERIOR TIBIAL ARTERY. VESSEL DIAMETER REPORTED AS 4MM. LESION EXHIBITED 65% STENOSIS. SLIGHT VESSEL TORTUOSITY AND MODERATE CALCIFICATION ARE REPORTED. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. A NON-MEDTRONIC INFLATION DEVICE WITH A CONTRAST AND SALINE MIX WERE USED FOR BALLOON INFLATION. IT IS REPORTED THAT DURING ADVANCEMENT OF THE DEVICE OVER THE WIRE AND INTO THE SHEATH THE BALLOON DETACHED. THE DEVICE WAS REMOVED AS A UNIT AND ANOTHER WIRE AND BALLOON WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11588789 ↗
• InjuryJul 9, 2019Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN WAS USING A NANOCROSS PTA BALLOON TO TREAT A LESION IN THE MID RIGHT POPLITEAL ARTERY. THE LESION WAS DESCRIBED AS SEVERELY CALCIFIED, WITH SLIGHT TORTUOUSITY AND ABOUT 7CM IN LENGTH IN A VESSEL DESCRIBED AS APPROX. 3.5-4MM IN DIAMETER. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY/HOOP. THE DEVICE WAS PREPPED WITHOUT ISSUE. A 6FR NON-MEDTRONIC SHEATH AND A 0.014 NON-MEDTRONIC GUIDEWIRE WERE USED WITH NO EMBOLIC PROTECTION. IT WAS REPORTED THAT DURING THE SECOND INFLATION OF THE BALLOON TO 10ATM, THE BALLOON BURST. MOST FRAGMENTS OF THE BALLOON WERE RETRIEVED BY SNARE AND ONE FRAGMENT WAS CAGED WITH A STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8771315 ↗

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,