NanoCross™ Elite AB14W060200150 (UDI 00821684067161)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684067161), received between Jan 29, 2019 and Jan 29, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjuryJan 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN USED AN EVERCROSS TO TREAT A SEVERELY CALCIFIED CTO IN THE RIGHT MID/DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. MODERATE TORTUOSITY WAS REPORTED. A 6FR NON-MEDTRONIC SHEATH WAS USED BUT NO EMBOLIC PROTECTION WAS USED. THE DEVICE WAS PREPPED WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED AND NO EXCESSIVE FORCE WAS USED. DURING BALLOON INFLATION A BURST OCCURRED. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. A 4X150MM EVERCROSS WAS USED TO COMPLETE THIS PART OF THE PROCEDURE. A NANOCROSS ELITE PTA BALLOON WAS SUBSEQUENTLY USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT DURING REMOVAL OF THE DEVICE FROM THE VESSEL, THE BALLOON DETACHED FROM THE SHAFT. THE PHYSICIAN ATTEMPTED TO EXTRACT THE DETACHED BALLOON WITH A SNARE WITHOUT SUCCESS AND THE DETACHED PORTION REMAINED IN THE PATIENT. THE PATIENT REQUIRED SURGERY BUT THE BALLOON WAS UNABLE TO BE RETRIEVED AND REMAINS IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8284304 ↗

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,