NanoCross™ Elite AB14W040120150 (UDI 00763000110161)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000110161), received between Jan 18, 2021 and Jan 18, 2021 — classified as 1 injury.

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.

• InjuryJan 18, 2021Burst Container or Vessel; Difficult to Remove; Burst Container or Vessel; Difficult to Remove

  PHYSICIAN WAS USING A NANOCROSS PTA BALLOON ALONG WITH 7FR SHEATH, 6MM SPIDER FX GUIDEWIRE AND EMBOLIC PROTECTION DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH 90% STENOSIS. THE VESSEL WAS SEVERELY TORTUOUS. THE VESSEL DIAMETER WAS 5-6MM. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. A 1/3 CONTRAST 2/3 SALINE WAS USED FOR INFLATION FLUID. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WASPREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING SECOND BALLOON INFLATION, A CIRCUMFERENTIAL/RADIAL BURST OCCURRED AT 10ATM. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THERE WAS DIFFICULTY REMOVING BALLOON FOLLOWING BALLOON INFLATION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. PATIENT WENT TO SURGERY AT SEPARATE FACILITY FOR REMOVAL OF BALLOON. BALLOON WAS INFLATED ONCE PRIOR TO RUPTURE TO PROFILE WITH NO PINCHING. SECOND INFLATION WENT TO PROFILE AS WELL WITHOUT PINCHING BEFORE RUPTURE. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11185264 ↗

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,