NanoCross™ Elite AB14W050040150 (UDI 00763000758066)Recalls & reported problems
Medtronic, Inc. · PTA AB14W050040150 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 00763000758066), received between Nov 12, 2024 and Nov 12, 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
- Deformation Due to Compressive Stress1
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.
InjuryNov 12, 2024Deflation Problem; Deformation Due to Compressive Stress; Deflation Problem; Deformation Due to Compressive Stress
A NANOCROSS PTA BALLOON WAS BEING USED FOR TREATMENT OF THE SUPERFICIAL FEMORAL ARTERY. A 6FR NON MEDTRONIC SHEATH WAS USED AND A 0.014" SPIDER GUIDEWIRE. A 4MM SPIDER WAS USED FOR EMBOLIC PROTECTION. IT WAS REPORTED DEFLATION DIFFICULTIES OCCURRED AND A KINK WAS NOTED ON THE BALLOON CATHETER, PROXIMAL TO THE BALLOON. MULTIPLE DRAWS WITH NEGATIVE PRESSURE ON A 20CC SYRINGE WERE USED TO DEFLATE THE BALLOON. DEFLATION TOOK LONGER THAN 10 MINUTES. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. ANOTHER MEDTRONIC DEVICE WAS USED TO COMPLETE THE CASE. NO ISSUES REPORTED WITH THIS DEVICE. NO HEALTH CONSEQUENCES OR IMPACT REPORTED FOR THIS PATIENT FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20663075 ↗
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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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