NanoCross™ Elite AB14W060200150 (UDI 00763000758349)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000758349), received between Oct 2, 2024 and Jun 26, 2025 — classified as 3 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE NANOCROSS ELITE OUTER PACKAGE WAS DAMAGED, AND A TEAR IN THE PACKAGING. THE STERILE PACKAGING WAS NOT INTACT. THE DAMAGE WAS IDENTIFIED DURING PRODUCT RECEIPT, AND THE DEVICE WAS NOT USED IN A PATIENT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22334484 ↗
• MalfunctionJun 19, 2025Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE NANOCROSS ELITE, THE BALLOON BURST ON THE FIRST INFLATION WHILE BEING USED IN THE SUPERFICIAL FEMORAL ARTERY. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT AND THERE WAS NO INJURY/INTERVENTION ASSOCIATED WITH THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22291777 ↗
• MalfunctionOct 2, 2024Deflation Problem; Deflation Problem

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON WITH A 6FR NON-MEDTRONIC (COOK) SHEATH AND A .014 NON-MEDTRONIC (CHOICEPT) GUIDEWIRE DURING TREATMENT OF A 250MM CALCIFIED LESION IN THE PATIENT¿S LEFT MID SUPERFICIAL FEMORAL ARTERY. MINIMAL TORTUOSITY ANDSEVERE CALCIFICATION WERE REPORTED. LESION EXHIBITED 70% STENOSIS. ARTERY DIAMETER REPORTED AS 6MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS PRE AND POST DILATED. A NON-MEDTRONIC (AC3200) INFLATION DEVICE WAS USED. 50/50 CONTRAST FLUID WAS USED. THE BALLOON WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. DEFLATION DIFFICULTIES WERE REPORTED. AFTER 5 MINUTES AND MULTIPLE ATTEMPTS AT APPLYING NEGATIVE PRESSURE THE BALLOON EVENTUALLY DEFLATED. THE DEVICE WAS SAFELY REMOVED AND A NEW NANOCROSS 6X200 DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352044 ↗