NanoCross™ Elite AB14W060120090Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000110475), received between Sep 8, 2022 and Sep 8, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deflation 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.

• MalfunctionSep 8, 2022Deflation Problem; Deflation Problem

  PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS ELITE PTA BALLOON ALONG WITH NON-MEDTRONIC 6FR SHEATH AND 0.014" GUIDEWIRE DURING PROCEDURE TO TREAT A LITTLE CALCIFIED, PLAQUE LESION IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH 60%- 70% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH WAS 6MM AND 150MM RESPECTIVELY. NO EMBOLIC PROTECTION WAS USED. A NON-MEDTRONIC INFLATION WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED WITH DEVICE SLOW TO DEFLATE AT THE LESION SITE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. INITIAL INFLATION FLAWLESS, UPON DEFLATION IT WAS EXTREMELY SLOW. DOUBLE NEGATIVE APPLIED TO INFLATION DEVICE IN ADDITION TO MANUAL ASPIRATION WITH 20CC SYRINGE VIA SIDE PORT OF INFLATION DEVICE. BALLOON REMOVED WITHOUT DIFFICULTY. STENT WAS UTILIZED. RE-ADVANCED PTA. INFLATION DEVICE ADDED 8 ML OF HEPARIN SALINE. UPON INFLATION PTA WAS NOT WELL VISUALIZED AT 12ATM, DEFLATED AND REINFLATED AT 12 ATM WITH NO CHANGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15377071 ↗

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,