NanoCross™ Elite AB14W030120150 (UDI 00821684066485)Recalls & reported problems
Ev3, Inc · PTA AB14W030120150 NANOCROSS 014 V04 · Class 2
All models of NanoCross Elite (63)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684066485), received between Oct 16, 2018 and Oct 16, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).
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.
Most reported problems
Device problems
- Burst Container or Vessel1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 16, 2018Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A NANOCROSS PTA CATHETER TO TREAT A SEVERELY CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE MID SUPERFICIAL FEMORAL ARTERY. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUE IDENTIFIED. THE DEVICE WAS INFLATED USING A NON-MDT INFLATION DEVICE. IT WAS REPORTED, DURING THE PROCEDURE, THAT A PINHOLE LEAK WAS OBSERVED DURING INFLATION AT 12ATM. THE DEVICE WAS REMOVED FROM THE PATIENT. ALL COMPONENTS OF THE DEVICE WERE REMOVED. ANOTHER NANOCROSS 3.5X80 WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. NO IMAGES OF THE PROCEDURE ARE AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7969108 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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