NanoCross™ Elite AB14W030080150 (UDI 00763000109806)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000109806), received between Jul 15, 2021 and Jul 15, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2021Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  PHYSICIAN USED A NANOCROSS PTA BALLOON WITH A SPIDER FX EMBOLIC PROTECTION DEVICE, NON-MEDTRONIC 6FR SHEATH AND NON-MEDTRONIC INFLATION DEVICE DURING TREATMENT OF AN 80MM PLAQUE LESION IN THE PATIENT¿S PROXIMAL, MID, AND DISTAL TIBIAL/POPLITEAL TRUNK. MODERATE VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. ARTERY DIAMETER REPORTED AS 3-4MM. LESION EXHIBITED 70% STENOSIS. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITH NO ISSUES IDENTIFIED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. A BURST/LEAK IS REPORTED DURING INITIAL BALLOON INFLATION. IT IS REPORTED THE BALLOON DID NOT INFLATE AT ALL WHEN PRESSURE WAS APPLIED. A LEAK IS SUSPECTED GIVEN THE BALLOON DID NOT INFLATE AT ALL, BUT LOCATION OF LEAK IS UNKNOWN. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12172237 ↗

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,