NanoCross™ Elite AB14W040150150 (UDI 00821684066829)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684066829), received between Jan 7, 2019 and Jan 7, 2019 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2019Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN ATTEMPTED TO USE A NANOCROSS BALLOON 014 WITH A NON-MEDTRONIC 6 FR SHEATH AND A NON-MEDTRONIC INFLATION DEVICE TO TREAT A FIBROUS LESION, MODERATELY CALCIFIED WITH CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). ARTERY LENGTH AND DIAMETER WERE 40 MM AND 6 MM, RESPECTIVELY. THE DEVICE WAS PREPPED AS PER THE IFU AND NO ISSUES WERE NOTED. THE PHYSICIAN EXPERIENCED RESISTANCE UPON ADVANCING WITH THE DEVICE THROUGH THE LESION, BUT NO EXCESSIVE FORCE WAS USED. THE DEVICE PASSED THROUGH A PREVIOUS DEPLOYED STENT. A BALLOON BURST (RUPTURE) WAS REPORTED DURING INFLATION AT 6 ATM. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE PHYSICIAN ATTEMPTED TO USE A SECOND BALLOON, A NANOCROSS ELITE 6 X 20 X 150 AND THE SAME ISSUE OCCURRED, THE BALLOON RUPTURED DURING INFLATION AT 6 ATM USING THE SAME INFLATION DEVICE. THE PROCEDURE WAS COMPLETED USING A 6 X 40 PACIFIC PLUS CROSS AND THEN A 6 X 20 FORTEX BALLOON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8221517 ↗