NanoCross™ Elite AB14W020210150 (UDI 00821684066201)Recalls & reported problems
Ev3, Inc · PTA AB14W020210150 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 00821684066201), received between Feb 22, 2018 and Apr 28, 2020 — 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
- Adverse Event Without Identified Device or Use Problem1
- Burst Container or Vessel1
- Use of Device Problem1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence 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 28, 2020Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem
PHYSICIAN USE A NANOCROSS PTA BALLOON CATHETER DURING PROCEDURE TO TREAT THE PEDAL ARTERY. BALLOON WAS INFLATED USING AN INFLATING DEVICE. IT WAS LATER REPORTED THAT THE BALLOON USED DURING PROCEDURE WAS AN EXPIRED PRODUCT. NO FURTHER PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10005598 ↗MalfunctionFeb 22, 2018Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED DURING INFLATION OF A NANOCROSS PTA BALLOON CATHETER, THE BALLOON BURST AND THE PROCEDURE COULD NOT BE CONTINUED. LESION MORPHOLOGY IS UNKNOWN. THE BALLOON WAS INFLATED ONCE PRIOR TO THE BURST. BURST PRESSURE AND THE TYPE OF BURST WERE NOT REPORTED. IT IS UNKNOWN IF THERE WERE ANY FRAGMENTS OF THE BALLOON. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND NO PATIENT INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7291059 ↗
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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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