NanoCross™ Elite AB14W040080150 (UDI 00821684066768)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821684066768), received between Nov 13, 2018 and Mar 22, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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.

• MalfunctionMar 22, 2019Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN WAS INTENDING TO USE A NANOCROSS TO TREAT A 40MM CALCIFIED LESION WITH 70-80% STENOSIS IN THE LEFT MID POSTERIOR TIBIAL ARTERY. VESSEL DIAMETER WAS 3-4MM WITH LITTLE TORTUOSITY. A NON MEDTRONIC 6-90 SHEATH AND A NITREX 0.14 300CM GUIDEWIRE WAS USED IN THE PROCEDURE. NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE TO THE DEVICE PACKAGING AND NO ISSUES REMOVING THE DEVICE FROM ITS PACKAGING. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED. THE GUIDEWIRE WAS ADVANCED STIFF END FIRST BUT IT WAS REPORTED THAT ANCILLARY DEVICE INTERACTION WAS ENCOUNTERED WITH THE GUIDEWIRE AND NANOCROSS. ANOTHER DEVICE WAS USED IN THE PROCEDURE AFTER THE GUIDEWIRE WAS REPOSITIONED. THIS DEVICE WAS PREPPED WITH NO ISSUES. THIS DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE BALLOON WAS INFLATED TWICE USING A BOSTON SCIENTIFIC INFLATION DEVICE WITH 60/40 HEP SAL/CONTRAST. THE FIRST INFLATION DID NOT HOLD PRESSURE. IT WAS RE-INFLATED TO 10ATM AND CONTINUED PRESSURE WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8443636 ↗
• MalfunctionFeb 26, 2019Material Rupture; Material Rupture

  THE PHYSICIAN INTENDED TO USE A NANOCROSS DEVICE TO TREAT A SEVERELY CALCIFIED LESION WITH 80% STENOSIS IN THE DISTAL POPLITEAL ARTERY. MODERATE TORTUOSITY WAS REPORTED. THERE WAS NO DAMAGE TO THE DEVICE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. NO EMBOLIC PROTECTION WAS USED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED AND NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT DURING INFLATION, WHILE USING A NON-MEDTRONIC INFLATION DEVICE, A BALLOON PIN HOLE BURST OCCURRED AT 8ATM. THE BALLOON WAS REMOVED AND ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. NO PATIENT INJURY WAS REPORTED. THE PATIENT WILL BE BROUGHT BACK FOR A BYPASS SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8369344 ↗
• MalfunctionNov 13, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS TO TREAT A SEVERELY CALCIFIED CTO (CHRONIC TOTAL OCCLUSION) LESION IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY(SFA). THE ARTERY DIAMETER AND LESION LENGTH WERE 6MM AND 350MM RESPECTIVELY. PHYSICIAN USED A NON-MEDTRONIC 6FR 11CM SHEATH, A NON-MEDTRONIC GUIDEWIRE AND A NON-MEDTRONIC INFLATION DEVICE. 50/50 SALINE/CONTRAST MIXTURE WAS USED. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS REPORTED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY AND WITHDRAWAL. IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY ADVANCING THE BALLOON THROUGH THE DEPLOYED STENT AS THE ARTERY WAS HEAVILY CALCIFIED. AFTER INFLATING THE BALLOON IN THE STENT, TO OPEN UP THE ARTERY, THE CALCIFIED VESSEL RECOILED AND APPLIED PRESSURE TO THE BALLOON MAKING IT DIFFICULT TO WITHDRAW FROM THE STENTED AREA AND THE PATIENT. THE PHYSICIAN APPLIED FORCE IN AN ATTEMPT TO REMOVE THE BALLOON CATHETER, IT CAME FREE BUT WAS HARD TO PULL INTO THE SHEATH. ADDITIONAL FORCE WAS APPLIED, THE BALLOON CATHETER CAME OUT BUT WAS LODGED IN THE DISTAL END OF THE SHE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8063590 ↗