NanoCross™ Elite AB14W020040150 (UDI 00763000109448)Recalls & reported problems
Ev3, Inc · PTA AB14W020040150 NANOCROSS 014 V05 · 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 00763000109448), received between May 22, 2023 and May 22, 2023 — 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.
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.
MalfunctionMay 22, 2023Burst Container or Vessel; Burst Container or Vessel
A PHYSICIAN WAS USING A NANOCROSS PTA BALLOON FOR THE TREATMENT OF A PLAQUE LESION WITH 70% STENOSIS IN THE MID REGION OF THE ANTERIOR TIBIAL ARTERY. THERE WAS MODERATE TORTUOSITY AND CALCIFICATION. THE DEVICE WAS NOT PREPPED AS PER THE IFU. A NON MEDTRONIC DEVICE WAS USED FOR BALLOON INFLATION. IT WAS REPORTED AT 10 ATM THE BALLOON BURST LONGITUDINALLY. BALLOON FRAGMENTS WERE RETRIEVED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. ANOTHER NANOCROSS WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY REPORTED FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16973809 ↗
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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- Coyote™ H74939185202210Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal200 reports
- Coyote™ ES H74939135254010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal127 reports
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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