NanoCross™ Elite AB14W020080150 (UDI 00821684066126)Recalls & reported problems
Ev3, Inc · PTA AB14W020080150 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684066126), received between Oct 4, 2018 and Apr 16, 2021 — classified as 2 malfunctions.
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
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 16, 2021Use of Device Problem; Use of Device Problem
PHYSICIAN WAS ATTEMPTING TO USE NANOCROSS PTA ALONG WITH NON-MEDTRONIC 5FR SHEATH AND 0.014" GUIDEWIRE DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE LEFT MID ANTERIOR TIBIAL ARTERY (ATA). THE VESSEL WAS LITTLE CALCIFIED. A NON-MEDTRONIC INFLATION DEVICE WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT EXPIRED PRODUCT WAS USED DURING PROCEDURE. THERE WERE NO ISSUES COMPLETING THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11677629 ↗MalfunctionOct 4, 2018Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN USED A NANOCROSS BALLOON DURING TREATMENT OF A PLAQUE LESION IN THE PATIENTS MID ANTERIOR TIBIAL ARTERY. SLIGHT CALCIFICATION REPORTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED THAT DURING FIRST BALLOON INFLATION THE BALLOON BURST (LONGITUDINALLY) AT AN UNKNOWN PRESSURE WHICH WAS BELOW RBP. NO BALLOON FRAGMENTS REMAINED IN THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A NEW NANOCROSS BALLOON. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7933768 ↗
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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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