NanoCross™ Elite AB14W030120150 (UDI 00763000109844)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000109844), received between Apr 5, 2024 and Jun 27, 2025 — classified as 2 malfunctions.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DURING TREATMENT IN THE PATIENTS RIGHT MID TIBIAL/POPLITEAL TRUNK USING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AB14W030120150 NANOCROSS 014 BALLOON, THERE WERE DEFLATION DIFFICULTIES. THERE WAS NO DAMAGE NOTED TO THE BALLOON CATHETER. THERE WERE NO ISSUES NOTED DURING INFLATION. THE BALLOON TOOK 5 MINUTES TO FULLY DEFLATE. THE PROCEDURE INVOLVED USE OF A 6FR X45 NON-MEDTRONIC SHEATH AND A .014 NON-MEDTRONIC GUIDEWIRE, WITH INFLATION PERFORMED USING A NON-MEDTRONIC INFLATION DEVICE AND 50/50 CONTRAST FLUID. THE BALLOON WAS DEFLATED USING NEGATIVE PRESSURE WITH A 60 CC SYRINGE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22344036 ↗
• MalfunctionApr 5, 2024Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON WITH A 6X45 NON-MEDTRONIC SHEATH AND A NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 120MM CALCIFIED LESION IN THE PATIENTS LEFT MID ANTERIOR TIBIAL ARTERY. MINIMAL VESSEL TORTUOSITY AND MODERATE VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED 30% STENOSIS. ARTERY DIAMETER REPORTED AS 3MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT PRE-DILATED. THE VESSEL WAS POST-DILATED. A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. 50/50 CONTRAST INFLATION FLUID WAS USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. INFLATION DIFFICULTIES DURING PROCEDURE WERE REPORTED. A LEAK WAS NOTED ON THE SHAFT OF THE DEVICE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A REPLACEMENT NON-MEDTRONIC DEVICE WAS USED TO COMPLETE PROCEDURE. NO PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19049187 ↗

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, Classified
  Medtronic 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,