NanoCross™ Elite AB14W030100150 (UDI 00821684066461)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684066461), received between Nov 12, 2019 and Nov 12, 2019 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2019Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  PHYSICIAN USED A NANOCROSS BALLOON WITH A NON-MEDTRONIC 6FR SHEATH AND NON-MEDTRONIC 0.009" GUIDEWIRE DURING TREATMENT OF A 100MM PLAQUE LESION IN THE PATIENT¿S PROXIMAL LEFT ANTERIOR TIBIAL ARTERY OF DIAMETER 3MM. MODERATE VESSEL TORTUOSITY AND CALCIFICATION ARE REPORTED. LESION EXHIBITED 80% STENOSIS. NO ISSUES NOTED REMOVING DEVICE FROM PACKAGING. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. THE NANOCROSS WAS ADVANCED WITHOUT ISSUE. NO RESISTANCE WAS ENCOUNTERED. THE NANOCROSS WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE BALLOON WAS INFLATED USING 30 CONTRAST/ 70 SALINE INFLATION FLUID WITH A NON-MEDTRONIC INFLATION DEVICE. IT WAS NOTED THE BALLOON WOULD NOT HOLD PRESSURE ON FIRST INFLATION AT 6ATM. THE BALLOON WAS REMOVED, AND A PINHOLE BURST WAS OBSERVED. A DIFFERENT NANOCROSS WAS THEN USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9309282 ↗

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,