NanoCross™ Elite AB14W020100150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000109509), received between May 11, 2021 and Nov 4, 2021 — 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.

• MalfunctionNov 4, 2021Inflation Problem; Material Twisted/Bent; Inflation Problem; Material Twisted/Bent

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON WITH A 6FR NON-MEDTRONIC SHEATH AND A 0.014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 120MM FIBROUS LESION IN THE PATIENT¿S MID ANTERIOR TIBIAL ARTERY. LITTLE VESSEL TORTUOSITY AND LITTLE CALCIFICATION ARE REPORTED. ARTERY DIAMETER REPORTED AS 2MM. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. A NON-MEDTRONIC INFLATION DEVICE WAS USED. 50/50 INFLATION FLUID WAS USED. THE BALLOON WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. IT IS REPORTED BALLOON INFLATION DIFFICULTIES OCCURRED AT AN INFLATION PRESSURE OF 8ATM. BALLOON JUST DID NOT INFLATE PROPERLY, VERY PROXIMAL AND VERY SMALL PORTION OF THE BALLOON INFLATED AND THE REST OF THE BALLOON DID NOT. THERE WAS NO LEAKS NOTED. NO INTERVENTION WAS REQUIRED TO REMOVE THE DEVICE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. A TWIST WAS NOTED ON THE PROXIMAL END

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751579 ↗
• MalfunctionMay 11, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS PTA BALLOON WITH A 7FR NON-MEDTRONIC SHEATH DURING TREATMENT OF A SOFT TISSUE LESION IN THE P ATIENT¿S DISTAL LEFT NON-MEDTRONIC. SLIGHT VESSEL CALCIFICATION AND MODERATE TORTUOSITY ARE REPORTED. 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. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT. A BALLOON BURST IS REPORTED AT 8ATM DURING BALLOON INFLATION. TWO PRIOR INFLATIONS HAD BEEN APPLIED THE DEVICE. THE BURST WAS NOTED DURING REMOVAL OF THE BALLOON FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AS NORMAL. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11804941 ↗

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,