NanoCross™ Elite AB14W040120150 (UDI 00763000757984)Recalls & reported problems
Medtronic, Inc. · PTA AB14W040120150 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 00763000757984), received between Feb 18, 2025 and Feb 18, 2025 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Deflation Problem1
- Difficult to Remove1
- Inflation 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.
MalfunctionFeb 18, 2025Deflation Problem; Inflation Problem; Difficult to Remove; Deflation Problem; Inflation Problem; Difficult to Remove
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY NANOCROSS 014 BALLOON, DEFLATION AND INFLATION DIFFICULTIES OCCURRED. THE BALLOON CATHETER EXPERIENCED DEFLATION DIFFICULTIES AND SLOWED INFLATION. THE BALLOON WAS NOT FULLY DEFLATED AND WAS REMOVED WITH DIFFICULTY. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE, WHICH WAS NOT A MEDTRONIC DEVICE. THE EVENT OCCURRED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY, MID-LOCATION, WITH A LESION LENGTH OF 120MM AND AN ARTERY DIAMETER OF 5.1MM. THE SHEATH USED WAS A NON-MEDTRONIC 6F, AND THE INFLATION DEVICE WAS A NON-MEDTRONIC DEVICE WITH 50/50 CONTRAST FLUID. THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21397694 ↗
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™ ES H74939134152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal279 reports
- 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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