NanoCross™ Elite AB14W060150150 (UDI 00763000758325)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000758325), received between Feb 19, 2025 and Dec 9, 2025 — classified as 1 injury, 1 malfunction.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF A FIBROUS LESION IN THE RIGHT PROXIMAL/MID SUPERFICIAL FEMORAL ARTERY WITH A NANOCROSS ELITE PTA BALLOON, THERE WAS A ONE-HOUR DELAY IN SURGERY DUE TO A DETACHED BALLOON AT THE TARGET LESION. ARTERY DIAMETER REPORTED AS 6MM. A 6FR NON-MEDTRONIC SHEATH WAS USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH 50/50 CONTRAST FLUID FOR BALLOON INFLATION. THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED 6MM PROTEGE EVERFLEX STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE VESSEL WAS POST-DILATED. THE DETACHED BALLOON WAS SNARED AND REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW MEDTRONIC DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23755875 ↗
• MalfunctionFeb 19, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A CALCIFIED LESION IN THE MID RIGHT POPLITEAL ARTERY USING A NANOCROSS ELITE, A PINHOLD BURST OCCURRED AT 10 ATMS DURING THE FIRST INFLATION. THE VESSEL HAD NOT BEEN PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. 50/50 CONTRAST FLUID WAS USED FOR INFLATION. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO BALLOON DETACHMENT OCCURRED. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21411439 ↗