NanoCross™ Elite AB14W060020150Recalls & reported problems
Medtronic, Inc. · PTA AB14W060020150 NANOCROSS 014 V06 · Class 2
All models of NanoCross Elite (31)
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 00763000758202), received between Sep 15, 2025 and Sep 15, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).
1 other recall cover devices cleared under the same FDA submission (K141118); they may or may not involve this specific model.
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
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.
MalfunctionSep 15, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT PLAQUE IN THE MID LEFT SUPERFICIAL FEMORAL ARTERY USING A NANOCROSS ELITE BALLOON, THE BALLOON BURST AT 10 ATM PRESSURE ON THE FIRST INFLATION. THE LESION LENGTH WAS 30MM AND THE ARTERY DIAMETER WAS 6MM. THE VESSEL WAS PRE-DILATED AND POST-DILATED, AND THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED PROTEGE STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE BALLOON DID NOT DETACH DURING THE EVENT, AND THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER NANOCROSS DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23050965 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K141118. One submission often covers many models, so check the product and lot details in each record.
- Z-0904-2025 · Dec 10, 2024 · Open, ClassifiedMedtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090,
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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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