NanoCross™ Elite AB14W040150150 (UDI 00763000758004)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000758004), received between Nov 3, 2025 and Nov 12, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (2 reports).

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.

• InjuryNov 12, 2025Deflation Problem; Inflation Problem; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Deflation Problem; Inflation Problem; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE NANOCROSS 014, DEFLATION DIFFICULTIES OCCURRED WHEN THE BALLOON WOULD NOT DEFLATE. A SMALL KINK IN THE CATHETER WAS NOTICED AFTER REMOVAL. THE PROCEDURE WAS ABORTED. THE TARGET LESION WAS LOCATED IN THE PERIPHERAL ARTERIES, SPECIFICALLY THE COMMON ILIAC ARTERY, SUPERFICIAL FEMORAL ARTERY, AND POPLITEAL ARTERY, WITH AN ARTERY DIAMETER OF 6MM AND CALCIFICATION PRESENT. THE VESSEL WAS PRE-DILATED AND THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE BALLOON WAS INFLATED USING AN INFLATION DEVICE, AND DEFLATION WAS ATTEMPTED BY SNARING THROUGH A TRAILBLAZER. NO ABNORMALITIES WERE REPORTED IN RELATION TO ANATOMY, AND INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533172 ↗
• MalfunctionNov 3, 2025Deflation Problem; Difficult to Remove; Compatibility Problem; Material Deformation; Deflation Problem; Difficult to Remove; Compatibility Problem; Material Deformation

  IT WAS REPORTED THAT DURING TREATMENT OF A SOFT TISSUE LESION IN THE MID LEFT POSTERIOR TIBIAL ARTERY USING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY NANOCROSS 014, THE BALLOON INFLATED AND TRACKED INTO THE BODY WITHOUT ISSUE, BUT DEFLATION DIFFICULTIES OCCURRED AS THE BALLOON WOULD NOT FULLY DEFLATE FOR APPROXIMATELY TWO MINUTES. THE BALLOON CATHETER APPEARED TO STRETCH DURING REMOVAL AND BECAME STUCK ON THE WIRE, REQUIRING BOTH THE BALLOON CATHETER AND WIRE TO BE REMOVED TOGETHER. AFTER REMOVAL FROM THE BODY, THE WIRE COULD NOT BE SEPARATED FROM THE CATHETER, AS IT WAS STUCK INSIDE, AND THE BALLOON CATHETER APPEARED STRETCHED AND DETACHED. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE OF THE SAME MAKE AND MODEL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450685 ↗

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,