NanoCross™ Elite AB14W025150150 (UDI 00821684066348)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684066348), received between Dec 8, 2017 and Jan 14, 2021 — classified as 1 injury, 1 malfunction.

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

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.

• InjuryJan 14, 2021Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE MID ANTERIOR TIBIAL ARTERY (ATA). THE VESSEL WAS LITTLE TORTUOUS. A NON-MEDTRONIC INFLATION DEVICE USED TO INFLATE THE BALLOON. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE ARE NO ISSUES NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT DURING BALLOON INFLATION, BALLOON BURST/LEAK/RUPTURE OCCURRED AT 8ATM. ALL BALLOON FRAGMENTS WERE NOT RETRIEVED. A STENT WAS IMPLANTED IN THE TIBIAL ARTERY TO CAGE IN THE BALLOON FRAGMENTS AND MAXIMIZE THE LUMEN. NO FURTHER PATIENT INJURY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11170492 ↗
• MalfunctionDec 8, 2017Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON DILATATION CATHETER TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT ANTERIOR TIBIAL ARTERY AND THE TIBIAL/ POPLITEAL TRUNK. THE ARTERY HAD NO TORTUOSITY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. NO RESISTANCE WAS FELT DURING THE ADVANCEMENT OF THE DEVICE AND NO EXCESSIVE FORCE WAS USED. THE NANOCROSS DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE BALLOON RUPTURED AT 8 ATMS DURING THE FIRST INFLATION. ALL FRAGMENTS WERE COLLECTED, NO INTERVENTION WAS REQUIRED. ANOTHER NANOCROSS PTA BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7102007 ↗