NanoCross™ Elite AB14W035040150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000109929), received between Oct 7, 2021 and Oct 27, 2023 — classified as 2 malfunctions.

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.

• MalfunctionOct 27, 2023Burst Container or Vessel; Burst Container or Vessel

  A PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON FOR TREATMENT OF A 150MM CALCIFIED LESION WITH CHRONIC TOTAL OCCLUSION IN THE MID LEFT TIBIAL/POPLITEAL TRUNK <(>&<)> POSTERIOR TIBIAL ARTERY. THE ARTERY WAS 3.5MM IN DIAMETER WITH MODERATE TORTUOSITY AND SEVERE CALCIFICATION. A 6FR NON MEDTRONIC SHEATH WAS USED. A SPIDER WAS USED FOR EMBOLIC PROTECTION. A NON MEDTRONIC INFLATION DEVICE WAS USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED PREDILITATED WITH 2.5MM X150 NANO CROSS. ONCE 3.5X40 NANO CROSS WAS INFLATED A PINHOLE BURST OCCURRED AT 14 ATM AT THE RE-ENTRY POINT WHERE IT WAS SEVERELY CALCIFIED. PTA WAS RETRIEVED AND NO DAMAGE WAS DONE TO THE ARTERY. THE DEVICE HAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS FELT DURING ADVANCEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18019744 ↗
• MalfunctionOct 7, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE THE NANOCROSS PTA BALLOON DURING PROCEDURE. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE BALLOON WAS INFLATED WITH AN INFLATION DEVICE. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES. THERE WERE INFLATION DIFFICULTIES. IT WAS REPORTED THAT THE BALLOON BURST DURING BALLOON INFLATION AT 4ATM. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12589950 ↗

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,