NanoCross™ Elite AB14W050060150 (UDI 00763000758080)Recalls & reported problems
Medtronic, Inc. · PTA AB14W050060150 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
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000758080), received between Sep 16, 2024 and Sep 16, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Deflation Problem” (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
- Deflation Problem1
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.
InjurySep 16, 2024Deflation Problem; Deflation Problem
PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON WITH A 6FR NON-MEDTRONIC SHEATH AND A .014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 60MM PLAQUE LESION IN THE PATIENTS LEFT MID POPLITEAL ARTERY. MINIMAL VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED CTO (CHRONIC TOTAL OCCLUSION-100%) STENOSIS. ARTERY DIAMETER REPORTED AS 6MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT PRE-DILATED. THE VESSEL WAS POST-DILATED. A NON-MEDTRONIC INFLATION DEVICE WAS USED. 50/50 CONTRAST FLUID WAS USED. THE BALLOON WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. DEFLATION DIFFICULTIES WERE REPORTED. THERE WERE NO ISSUES NOTED DURING INFLATION. THERE WAS NO DAMAGE NOTED TO THE BALLOON CATHETER. THE BALLOON WAS EVENTUALLY FULLY DEFLATED FOR REMOVAL. DEFLATION TOOK 5MINS. PHYSICIAN USED A 60C
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20222513 ↗
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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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