NanoCross™ Elite AB14W020120150 (UDI 00763000109523)Recalls & reported problems
Ev3, Inc · PTA AB14W020120150 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 00763000109523), received between Jun 19, 2025 and Jun 19, 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.
MalfunctionJun 19, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE NANOCROSS 014 BALLOON, THE BALLOON BURST ON THE FIRST INFLATION IN THE MID RIGHT ANTERIOR TIBIAL ARTERY, WHICH HAD A MODERATE CALCIFIED LESION MEASURING 130MM IN LENGTH AND 2.0MM IN DIAMETER. THE SHEATH USED WAS A 6F NON-MEDTRONIC, AND 50/50 CONTRAST WAS USED AS THE INFLATION FLUID. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE, AND THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. THE DEVICE WAS SAFELY REMOVED FROMTHE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO HEALTH CONSEQUENCES OR IMPACT WERE REPORTED, AND THE PATIENT WAS ALIVE WITH NO INJURY. .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22289025 ↗
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,
Other Catheter, angioplasty, peripheral, transluminal devices
- Coyote™ ES H74939135152010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal879 reports
- Coyote™ ES H74939135204010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal585 reports
- Coyote™ ES H74939135202010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal437 reports
- Coyote™ ES H74939135304010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal384 reports
- Coyote™ ES H74939135404010Boston Scientific Corporation · Catheter, angioplasty, peripheral, transluminal293 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page