NanoCross™ Elite AB14W030040150 (UDI 00763000757588)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000757588), received between Nov 18, 2024 and May 1, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionMay 1, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE NANOCROSS 014, A LEAK IN THE BALLOON WAS NOTED. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE WITHOUT ISSUE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT, AND THERE WAS NO INJURY OR INTERVENTION ASSOCIATED WITH THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21946652 ↗
• InjuryNov 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A 2.5X60MM PACIFIC PLUS PTA BALLOON DURING TREATMENT OF THE PATIENT¿S COMMON ILIAC VEIN (CIV) & EXTERNAL ILIAC VEIN (EIV). THE DEVICE WAS PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. AN INFLATION DEVICE WAS USED. 50/50 CONTRAST INFLATIONFLUID WAS USED. TRACKING DIFFICULTY DURING INITIAL ADVANCEMENT WAS REPORTED. MODERATE RESISTANCE WAS NOTED, OTHER BALLOON (BARD ATLAS) WAS UNABLE TO CROSS THE LESION. IT WAS REPORTED THAT THE 2.5X60MM PACIFIC PLUS BALLOON GOT STUCK ON AN 018 NON-MEDTRONIC WIRE AND WAS SAFELY REMOVED WITH THE WIRE FROM THE PATIENT. THE PHYSICIAN THEN ATTEMPTED TO USE A 7X40MM PACIFIC PLUS PTA BALLOON. IT WAS REPORTED THAT THE 7X40MM PACIFIC PLUS GOT STUCK AND DETACHED AT THE TARGET LESION AS THEY TRIED TO REMOVE IT. ONLY A PARTIAL PIECE OF THE BALLOON WAS REMOVED. THE DETACHED COMPONENT WAS LEFT IN THE PATIENT. PHYSICIAN THEN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON TO PULL OUT THE DETACHED 7X40MM PACIFIC PLUS BUT THE NANOCROSS ELITE ALSO GOT STUCK AND DETACHED, THE NANOCROSS WAS REMOVED WITH A SNARE. THE DETACHED NANOCROSS ELITE WAS REMOVED FROM THE PATIENT. PROCEDURE WAS ABORTED. THE PATIENT MAY NEED SURGICAL INTERVENTION TO REMOVE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20706932 ↗

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,