NanoCross™ Elite AB14W035150150Recalls & reported problems
Ev3, Inc · PTA AB14W035150150 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000110024), received between Sep 6, 2021 and Sep 6, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Deflation Problem” (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
- Deflation Problem1
Patient problems
- Unspecified Tissue Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 6, 2021Deflation Problem; Deflation Problem
PHYSICIAN WAS ATTEMPTING TO USE THE NANOCROSS PTA BALLOON DURING PROCEDURE TO TREAT THE TIBIAL/POPLITEAL TRUNK. THERE WERE NO ISSUES WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THERE WERE DEFLATION ISSUES AND DEVICE WOULD NOT DEFLATE AT THE LESION SITE. THE PROXIMAL CATHETER WAS CUT OFF BY THE PHYSICIAN SO THAT THE BALLOON WOULD DEFLATE. NO PATIENT INJURY REPORTED.
Patient problems: Unspecified Tissue Injury
MAUDE report 12428489 ↗
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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