NanoCross™ Elite AB14W060080150 (UDI 00763000758264)Recalls & reported problems
Medtronic, Inc. · PTA AB14W060080150 NANOCROSS 014 V06 · Class 2
All models of NanoCross Elite (31)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000758264), received between Jun 19, 2025 and Jun 19, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Dec 10, 2024Class IIOpen, Classified
There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
Z-0904-2025 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Burst Container or Vessel1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT PLAQUE IN THE MID LOCATION OF THE LEFT SUPERFICIAL FEMORAL ARTERY USING A NANOCROSS ELITE 6MM X 80MM X 150CM BALLOON, A PIN HOLE BALLOON BURST OCCURRED DURING THE FIRST INFLATION. A NON-MEDTRONIC INFLATION DEVICE AND 50/50 CONTRAST INFLATION FLUID WERE USED FOR BALLOON INFLATION. THE BALLOON DID NOT DETACH DURING THE EVENT. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22289504 ↗
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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 · each recall links to the FDA recall notice
- 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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