NanoCross™ Elite AB14W060080150 (UDI 00763000110444)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000110444), received between Sep 3, 2020 and Sep 3, 2020 — 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.

• MalfunctionSep 3, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON CATHETER ALONG WITH A NON-MEDTRONIC 6FR SHEATH AND NITREX 0.014" GUIDE WIRE DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED PLAQUE LESION IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH 80% STENOSIS. THE VESSEL DIAMETER AND LESION LENGTH ARE 6MM AND 60MM RESPECTIVELY. A NON-MEDTRONIC INFLATION DEVICE WAS USED TO INFLATE THE BALLOON. THERE WAS NO DAMAGE TO DEVICE PACKAGING. THERE WAS NO ISSUE NOTED WHILE REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. DURING SECOND BALLOON INFLATION A CIRCUMFERENTIAL/RADIAL BURST OCCURRED AT 12 ATM. ALL BALLOON FRAGMENTS WERE RETRIEVED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE OCCURRED WHILE ADVANCING DEVICE. IT WAS REPORTED THAT PHYSICIAN WAS POST DILATING A STENT WHEN THE BALLOON RUPTURED. THE BALLOON WAS THEN REMOVED WITH ALL PIECES ATTACHED. A SECOND NANOCROSS BALLOON WAS USED TO FINISH DILATING THE STENT. NO PATIENT INJURY OR OTHER ISSUES HAPPENED DURING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10487260 ↗

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,