NanoCross™ Elite AB14W030040150 (UDI 00821684066409)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684066409), received between Jul 22, 2019 and Jun 23, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2020Difficult to Remove; Difficult to Remove

  PHYSICIAN USED A NANOCROSS PTA BALLOON ALONG WITH NON-MEDTRONIC 6FR SHEATH AND 0.014 GUIDE WIRE DURING PROCEDURE TO TREAT A SLIGHTLY CALCIFIED PLAQUE LESION IN THE DISTAL POSTERIOR TIBIAL ARTERY WITH 95% STENOSIS. THE VESSEL DIAMETER AND LESION LENGTH ARE 3MM AND 20MM RESPECTIVELY. THE VESSEL WAS LITTLE TORTUOUS. THE BALLOON WAS INFLATED USING AN INFLATION DEVICE. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. REMOVAL DIFFICULTY OCCURRED. IT WAS REPORTED IT WAS DIFFICULT TO REMOVE THE BALLOON FOLLOWING BALLOON INFLATION. FORCE WAS USED DURING WITHDRAWAL. THE BALLOON WAS SAFELY REMOVED OFF THE WIRE. THE DEVICE WAS FULLY DEFLATED UPON WITHDRAWAL ATTEMPT. PHYSICIAN HAD TO REWIRE LESION AND BALLOON COULD NOT BE FLUSHED AFTER IT WAS REMOVED. NO VESSEL DAMAGE OCCURRED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10183845 ↗
• MalfunctionJul 22, 2019Leak/Splash; Leak/Splash

  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. VESSESL DIAMETER WAS 3-4MM WITH LITTLE TORTUOSITY. A COOK 6-90 ANSEL 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, THE WIRE EXITED THE CATHETER JUST PROXIMAL TO THE BALLOON. 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 BALLOON BURST ON FIRST I NFLATION. TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8811919 ↗