NanoCross™ AB14W020150150Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684059326), received between May 15, 2018 and May 15, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K082854); they may or may not involve this specific model.

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 16, 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.

• MalfunctionMay 15, 2018Inflation Problem; Material Separation; Inflation Problem; Material Separation

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A NANOCROSS DEVICE WITH A 5FR SHEATH AND NON-MDT GUIDEWIRE FOR TREATMENT OF A 110-130MM LESION IN THE PATIENTS POSTERIOR TIBIAL ARTERY OF DIAMETER 1.5-2.0MM. VESSEL WAS REPORTED TO BE MODERATELY TORTUOUS, SLIGHTLY CALCIFIED BUT % STENOSIS WAS UNKNOWN. A MDT INFLATION DEVICE WAS USED WITH CONTRAST OMNIPAQUE INFLATION FLUID. EMBOLIC PROTECTION WAS NOT USED. IT WAS REPORTED THAT THE DEVICE WAS PREPPED WITHOUT ISSUE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED NOR WAS EXCESSIVE FORCE USED WHEN ADVANCING THE DEVICE. INFLATION DIFFICULTIES WERE EXPERIENCED AT AN INFLATION PRESSURE OF 8ATM. THE INFLATION COULD NOT BE OBSERVED UNDER FLUORO. THE DEVICE WAS REMOVED AND ANOTHER NANOCROSS WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7513624 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082854. One submission often covers many models, so check the product and lot details in each record.

• Z-0789-2011 · Nov 12, 2010 · Terminated
  ev3 NanoCross 0.14 OTW PTA Dilatation Catheter, sterilized using ethylene oxide gas. REF #'s: AB14W040040150, AB14W030040150, AB14W020040150, AB14W025080150, AB14W020080150, AB14