NanoCross™ Elite AB14W030100150 (UDI 00763000109820)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000109820), received between Dec 7, 2021 and Mar 28, 2023 — 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.

• MalfunctionMar 28, 2023Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  A PHYSICIAN ATTEMPTED TO USE TWO NANOCROSS BALLOONS DURING TREATMENT OF CALCIFIED LESIONS WITH CHRONIC TOTAL OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND THE TIBIAL/POPLITEAL TRUNK (TPT). THE DIAMETER OF THE SFA WAS 5MM AND THE TPT WAS 3MM. THE LENGTH OF THE LESION WAS 20-40MM. THE DEGREE OF TORTUOSITY AND CALCIFICATION WAS MODERATE. A 6FR NON MEDTRONIC SHEATH AND A NITRIX GUIDEWIRE WERE USED. THE DEVICES WERE PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE BALLOONS WERE INFLATED USING A NON MEDTRONIC DEVICE WITH HEP SALINE 60/CONTRAST 40. IT WAS REPORTED THE PHYSICIAN INITIALLY USED A 3MM BALLOON TO PRE DILATE THE CHRONIC TOTAL OCCLUSION IN THE SFA. HAWKPLUS M WAS USED SUCCESSFULLY. PHYSICIAN ATTEMPTED TO INFLATE A 5MM NANOCROSS BALLOON AND IT RUPTURED AT 8 ATM DURING THE INITIAL INFLATION AND WAS REMOVED INTACT WITH NO FRAGMENTS NOTED. THEN ATTEMPTED TO INFLATE A 3MM BALLOON IN THE TPT UNSUCCESSFULLY, IT DID NOT REGISTER PRESSURE AND HAD ONE INFLATION AT 8 ATM FOR TWO MINUTES, BURST AND WAS REMOVED INTACT WITH NO FRAGMENTS NOTED. THEY THEN USED 2.5-100 NANOCROSS SUCCESSFULLY IN TPT AND DEPLOYED AN ENTRUST STENT. THE SFA WAS POST DILATED WITH A NANOCROSS AT 8 ATM FO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16626251 ↗
• MalfunctionDec 7, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS PTA BALLOON WITH A 6FR, 45CM NON-MEDTRONIC SHEATH, 0.014, 300CM NON-MEDTRONIC GUIDEWIRE AND SPIDER FX EMBOLIC PROTECTION DEVICE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENT'S RIGHT MID AND DISTAL POPLITEAL ARTERY. SEVERE VESSEL CALCIFICATION AND SLIGHT TORTUOSITY ARE REPORTED. LESION EXHIBITED 80% STENOSIS. THERE WAS NO  DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOTED DURING ADVANCEMENT BUT NO EXCESSIVE FORCE WAS USED. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. A BALLOON BURST IS REPORTED DURING INFLATION TO 8ATM. NO BALLOON FRAGMENTS REMAIN IN THE PATIENT. ADDITIONAL PTA BALLOONS WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12949310 ↗

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,