NanoCross™ Elite AB14W060040150 (UDI 00821684067048)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684067048), received between Jul 31, 2018 and Dec 3, 2018 — classified as 2 malfunctions.

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.

• MalfunctionDec 3, 2018Leak/Splash; Leak/Splash

  THE PHYSICIAN INTENDED TO USE THE NANOCROSS ELITE WITH A 6F SHEATH, 0.014 GUIDEWIRE AND NON-MEDTRONIC INFLATION DEVICE TO TREAT A MODERATELY CALCIFIED 100MM LESION IN THE SUPERFICIAL FEMORAL ARTERY, DIAMETER 6MM. THE CATHETER WAS PREPPED AS PER IFU WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED A PIN HOLE LEAK WAS OBSERVED AT 4ATMS DURING FIRST INFLATION. ALL COMPONENTS WERE REMOVED FROM THE PATIENT AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8124298 ↗
• MalfunctionJul 31, 2018Burst Container or Vessel

  THE PHYSICIAN USED A NANOCROSS ELITE WITH A NON-MEDTRONIC INFLATION DEVICE FOR THE TREATMENT OF A SEVERELY CALCIFIED LESION IN THE PATIENTS DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION EXHIBITED 90% STENOSIS. SLIGHT TORTUOSITY WAS REPORTED. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED THAT DURING BALLOON INFLATION A LONGITUDINAL BALLOON BURST OCCURRED AT A PRESSURE OF 8 ATMS. AN ADDITIONAL 6X40 BALLOON WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7734237 ↗

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,