NanoCross™ Elite AB14W030150150 (UDI 00821684066508)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684066508), received between Mar 23, 2017 and Apr 6, 2018 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 6, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A NANOCROSS DEVICE WITH A NON-MEDTRONIC 7FR SHEATH AND 0.014¿ GUIDEWIRE FOR TREATMENT OF A SEVERELY CALCIFIED 60 MM CTO (CHRONIC TOTAL OCCLUSION-100%) LESION IN THE MID RIGHT POPLITEAL ARTERY. THE VESSEL WAS DESCRIBED AS BEING MODERATELY TORTUOUS AND 4 MM IN DIAMETER. IT IS REPORTED THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. DURING THE FIRST BALLOON INFLATION AT NOMINAL PRESSURE (8 ATMS), THE BALLOON IS REPORTED TO HAVE BURST. PART OF THE BALLOON IS REPORTED TO HAVE SNEERED OFF ON CALCIFICATION. THE PHYSICIAN THEN DEPLOYED A STENT TO REVASCULARIZE AND PIN UP THE REMAINING BALLOON MATERIAL TO THE VESSEL WALL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7403073 ↗
• MalfunctionDec 6, 2017Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON DILATATION CATHETER TO TREAT A SEVERELY CALCIFIED 100MM CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE LEFT MID-DISTAL ANTERIOR TIBIAL ARTERY. THE ARTERY HAD A DIAMETER OF 3MM AND HAD LITTLE TORTUOSITY. THE PROCEDURE USED A 7 FR NON-MEDTRONIC 45 CM SHEATH AND A 0.014" 300 CM NON-MEDTRONIC GUIDEWIRE. THE BALLOON WAS INFLATED USING A MEDTRONIC INFLATION DEVICE WITH 50/50 CONTRAST HEP/ SALINE FLUID, AS PER THE IFU. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE VESSEL WAS NOT PRE-DILATED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT DURING THE FIRST INFLATION AT 8 ATM, THE BALLOON BURST OCCURRED. THE BALLOON WAS REMOVED BY WITHDRAWING OVER THE WIRE UNDER FLUOROSCOPY. THE PROCEDURE WAS COMPLETED USING A NON-MEDTRONIC BALLOON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7089989 ↗
• InjuryMar 23, 2017Burst Container or Vessel; Material Fragmentation; Burst Container or Vessel; Material Fragmentation

  DURING AN ATTEMPT TO TREAT THE POSTERIOR TIBIAL ARTERY (PTA) REPORTED TO BE SEVERELY CALCIFIED WITH LITTLE TORTUOSITY USING NANOCROSS ELITE BALLOON CATHETER, IT WAS REPORTED THAT THE NANOCROSS ELITE BALLOON RUPTURED ON FIRST INFLATION. AFTER THE BALLOON RUPTURED THE PHYSICIAN COULD NOT GET THE BALLOON BACK OUT OF THE VESSEL. THE BALLOON THEN DETACHED FROM THE BALLOON CATHETER. PHYSICIAN MADE NUMEROUS ATTEMPTS TO SNARE AND REMOVE THE BALLOON. REMAINING PORTION OF THE BALLOON CATHETER WAS REMOVED AND THE SHEATHS WERE REMOVED. THE PHYSICIAN WAS NOT ABLE TO RETRIEVE THE BALLOON AND REMAINS IN THE PATIENT. NO FURTHER CLINICAL SEQUELAE REPORTED FOR THIS EVENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6428972 ↗