NanoCross™ Elite AB14W050120150 (UDI 00821684066966)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684066966), received between Apr 10, 2018 and Feb 12, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).

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.

• InjuryFeb 12, 2019Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A 5X120X150 NANOCROSS ELITE PTA BALLOON TO TREAT A SLIGHTLY CALCIFIED SLIGHTLY TORTUOUS LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY(SFA). THE ARTERY DIAMETER AND LESION LENGTH WERE REPORTED TO BE 5MM & 20MM, RESPECTIVELY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE TRAY/HOOP. THE DEVICE WAS PREPPED WITHOUT ISSUE. NO EMBOLIC PROTECTION WAS USED. THE DEVICE WAS INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED ON ADVANCING THE DEVICE TO THE TARGET LESION. THERE WERE WIRE MOVEMENT ISSUES REPORTED AND THE GUIDEWIRE LOCKED UP DURING THE PROCEDURE. THE NANOCROSS ELITE PTA BALLOON WAS REPORTED TO HAVE RUPTURED DURING INFLATION AT 14ATM. THE PROCEDURE WAS COMPLETED USING A SHEATH AND THE BALLOON WAS REMOVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; Patient Problem/Medical Problem

  MAUDE report 8330440 ↗
• MalfunctionApr 10, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN USED A NANOCROSS DEVICE WITH A SPIDER FX AND NON-MDT INFLATION DEVICE FOR THE TREATMENT OF A SEVERELY CALCIFIED LESION IN THE MID-LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS REPORTED TO EXHIBIT 50% STENOSIS AND THE VESSEL WAS REPORTED TO BE SLIGHTLY TORTUOUS. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. CONTRAST AND HEPARINIZED SALINE SOLUTION WAS USED FOR INFLATION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND THERE WAS RESISTANCE EXPERIENCED DURING ADVANCEMENT OF THE DEVICE. IT WAS REPORTED THAT FOLLOWING THE FIRST INFLATION OF THE DEVICE TO 10 ATM A PIN HOLE BURST WAS OBSERVED. THE BALLOON DID NOT FRAGMENT AND WAS REPORTED TO HAVE BEEN RETRIEVED SUCCESSFULLY. ANOTHER NANOCROSS WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7410603 ↗

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,