NanoCross™ Elite AB14W025040150 (UDI 00821684066249)Recalls & reported problems
Ev3, Inc · PTA AB14W025040150 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 00821684066249), received between Nov 26, 2018 and Nov 26, 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.
MalfunctionNov 26, 2018Burst Container or Vessel; Burst Container or Vessel
THE PHYSICIAN ATTEMPTED TO USE A NANOCROSS BALLOON WITH A 6 FR NON-MDT SHEATH AND A NON-MDT 0.014" GUIDEWIRE TO TREAT A 40MM CALCIFIED LESION IN THE MID LEFT TIBIAL/POPLITEAL TRUNK. THE ARTERY HAD A 2.5MM DIAMETER AND WAS NOT TORTUOUS. THE NANOCROSS WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. NO RESISTANCE WAS ENCOUNTERED ADVANCING THE BALLOON AND NO EXCESS FORCE WAS USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. DURING INITIAL BALLOON INFLATION USING A NON-MDT INFLATION DEVICE AND CONTRAST/ SALINE SOLUTION A PINHOLE BURST OCCURRED AT 6 ATMS. NO BALLOON MATERIAL NEEDED TO BE RETRIEVED. THE PROCEDURE WAS COMPLETED USING ATHERECTOMY AND STENTING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8101226 ↗
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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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