NanoCross™ Elite AB14W050020090Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000758035), received between Oct 11, 2024 and Oct 29, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Deflation Problem” (3 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.

• InjuryOct 29, 2024Deflation Problem; Deflation Problem

  A NANOCROSS ELITE BALLOON WAS BEING USED FOR TREATMENT. A 6FR SHEATH AND A NITREX GUIDEWIRE WERE USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED WITH SALINE INFLATION FLUID. NO ISSUES NOTED DURING INFLATION. IT WAS REPORTED DEFLATION DIFFICULTIES OCCURRED. A 20CC SYRINGE WITH NEGATIVE PRESSURE WAS USED AND DEFLATION TOOK JUST OVER 1 MINUTE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558336 ↗
• InjuryOct 14, 2024Deflation Problem; Deflation Problem

  A PHYSICIAN WAS USING A NANOCROSS PTA BALLOON DURING A RADIAL/PERFORANT FISTULA CREATION PROCEDURE IN THE MID RIGHT REGION OF THE VESSEL. THE ARTERY WAS 5MM IN DIAMETER. THE IFU WAS FOLLOWED. A 6FR SHEATH AND A NITREX GUIDEWIRE WERE USED. THE VESSEL WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND THERE WAS NO RESISTANCE ENCOUNTERED DURING ADVANCEMENT. A NON MEDTRONIC INFLATION DEVICE WAS USED WITH SALINE FOR BALLOON INFLATION. THERE WERE NO ISSUES NOTED DURING INFLATION AND NO DAMAGE NOTED TO THE BALLOON CATHETER. IT WAS REPORTED DEFLATION DIFFICULTIES OCCURRED, A 20CC SYRINGE WAS USED WITH NEGATIVE PRESSURE TO DEFLATE THE BALLOON. DEFLATION TOOK LONGER THAN 1 MINUTE. THE DEVICE EVENTUALLY FULLY DEFLATED AND WAS REMOVED SAFELY FORM THE PATIENT. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20439937 ↗
• InjuryOct 11, 2024Deflation Problem; Deflation Problem

  A PHYSICIAN WAS USING A NANOCROSS PTA BALLOON DURING A RADIAL/PERFORANT FISTULA CREATION PROCEDURE IN THE MID RIGHT REGION OF THE VESSEL. THE ARTERY WAS 5MM IN DIAMETER. THE IFU WAS FOLLOWED. A 6FR SHEATH AND A NITREX GUIDEWIRE WERE USED. THE VESSEL WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND THERE WAS NO RESISTANCE ENCOUNTERED DURING ADVANCEMENT. A NON MEDTRONIC INFLATION DEVICE WAS USED WITH SALINE FOR BALLOON INFLATION. THERE WERE NO ISSUES NOTED DURING INFLATION AND NO DAMAGE NOTED TO THE BALLOON CATHETER. IT WAS REPORTED DEFLATION DIFFICULTIES OCCURRED, A 20CC SYRINGE WAS USED WITH NEGATIVE PRESSURE TO DEFLATE THE BALLOON. DEFLATION TOOK LONGER THAN 1 MINUTE. THE DEVICE EVENTUALLY FULLY DEFLATED AND WAS REMOVED SAFELY FORM THE PATIENT. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20426204 ↗