NanoCross™ Elite AB14W030080150 (UDI 00821684066447)Recalls & reported problems
Ev3, Inc · PTA AB14W030080150 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 00821684066447), received between Nov 8, 2017 and Nov 8, 2017 — 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.
MalfunctionNov 8, 2017Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN INTENDED TO USE A NANOCROSS PTA DILATATION CATHETER FOR THE TREATMENT OF A SEVERELY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) LESION IN THE SFA. A 6 FRENCH NON-MEDTRONIC 55CM SHEATH AND A 0.035¿ NON-MEDTRONIC GUIDEWIRE WERE USED. NO EMBOLIC PROTECTION WAS USED. AN UNKNOWN INFLATION DEVICE WAS USED WITH CONTRAST AND HEPARINIZED SALINE. DEVICE WAS PREPPED WITHOUT ISSUE. IT WAS REPORTED THAT A CIRCUMFERENTIAL/RADIAL BALLOON BURST OCCURRED AT AN INFLATION PRESSURE OF 14ATMS DURING THE PROCEDURE. DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE BUT NO EXCESSIVE FORCE WAS USED. PROCEDURE COMPLETED BY PTA AND STENTING WITH 2 EVERFLEX 200MM STENTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7012250 ↗
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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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