NanoCross™ Elite AB14W050200150 (UDI 00763000758189)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000758189), received between Dec 13, 2024 and Sep 30, 2026 — classified as 1 injury, 2 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 10, 2024Class IIOpen, Classified

   There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.

   Z-0904-2025 · Root cause: Process change control · Recall details · FDA record ↗

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.

• MalfunctionSep 30, 2026Burst Container or Vessel

  It was reported that during use of a Nanocross Elite PTA balloon catheter device, for the treatment of a calcified lesion in the proximal and mid section of the left superficial femoral artery, a pin-hole balloon burst (Balloon Burst AT, BELOW, or UNKNOWN Rated Burst Pressure) occurred on the second inflation. The vessel was post-dilated with a (Medtronic) 5 x 150 Nanocross. The balloon did not pass through a previously deployed stent. No resistance was encountered when advancing the device. The balloon was inflated with a (Merit Medical) inflation device using 50/50 contrast fluid. No damage was noted to the packaging and no issues were noted when removing the device from the hoop/tray. The IFU was followed without issue. It is not known at what pressure the balloon burst. The balloon did not detach during the procedure. The device was safely removed from the patient. The procedure was completed using a new (Medtronic) 5 x 150 Nanocross device. The patient was reported as alive, with no injury. No injury or intervention was associated with this event. No health consequences or impact were reported as a result of this event. No patient symptoms or complications have been reported a

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948212 ↗
• MalfunctionJun 27, 2025Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING TREATMENT OF A CALCIFIED LESION IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY USING THE NANOCROSS ELITE 5MM X 200MM X 150CM BALLOON, THERE WERE DEFLATION DIFFICULTIES AND THE BALLOON WAS TAKEN TO 16 ATM WITH MINIMAL INFLATION. THE SHEATH USED WAS A 6FR X 45 NON-MEDTRONIC SHEATH AND THE GUIDEWIRE WAS A .014 NON-MEDTRONIC GUIDEWIRE. THE BALLOON WAS INFLATED WITH A 50/50 CONTRAST SOLUTION USING A NON-MEDTRONIC INFLATION DEVICE. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. THERE WAS NO DAMAGE NOTED TO THE BALLOON CATHETER. THE BALLOON WAS EVENTUALLY FULLY DEFLATED FOR REMOVAL USING NEGATIVE PRESSURE FROM THE INFLATION DEVICE, WHICH TOOK 2 MINUTES. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE OF THE SAME MAKE AND MODEL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344090 ↗
• InjuryDec 13, 2024Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  AN ISSUE WAS REPORTED DURING A PROCEDURE INVOLVING THE NANOCROSS ELITE BALLOON. THE PROCEDURE WAS TAKING PLACE IN THE LEFT SUPERFICIAL FEMORAL ARTERY, TARGETING A SOFT TISSUE LESION WITH A LENGTH OF 250MM AND THE ARTERY DIAMETER WAS 6MM. THE BALLOON PASSED THROUGH TWO PREVIOUSLY IMPLANTED PROTEGE EVERFLEX. NO RESISTANCE DURING ADVANCEMENT. A MEDTRONIC EVEREST INFLATION DEVICE WAS USED WITH 60/49 SALINE TO CONTRAST INFLATION FLUID. THE BALLOON BURST AT A PRESSURE OF 8ATM DURING THE SECOND INFLATION AND DETACHED, LEADING TO A DELAY IN SURGERY AS THE MEDICAL TEAM SPENT AN ADDITIONAL HOUR ATTEMPTING TO RETRIEVE THE BALLOON MATERIAL FROM THE PATIENT'S ARTERY. DESPITE THESE EFFORTS, NOT ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED, AND A PORTION OF THE DEVICE REMAINED IN THE PATIENT. THE DETACHED BALLOON MATERIAL WAS TRAPPED IN THE EXTERNAL ILIAC ARTERY USING A VISIPRO STENT TO RESTORE BLOOD FLOW. THE CATHETER WAS SUCCESSFULLY REMOVED, BUT THE BALLOON MATERIAL REMAINED JAILED WITH THE STENT.

  Patient problems: Insufficient Information

  MAUDE report 20923778 ↗