NanoCross™ Elite AB14W050040150 (UDI 00763000110246)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000110246), received between Nov 10, 2020 and Aug 23, 2022 — classified as 1 injury, 2 malfunctions.

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2022Deflation Problem; Deflation Problem

  A NANOCROSS ELITE BALLOON WAS BEING USED TO TREAT A CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY. LITTLE TORTUOSITY AND CALCIFICATION WERE REPORTED. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE USED. INFLATION DEVICE WAS USED TO INFLATE THE BALLOON. DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. IT IS REPORTED BALLOON DEFLATION DIFFICULTIES OCCURRED, DEVICE SLOW TO DEFLATE AT THE LESION SITE IT TOOK ABOUT 5-10 MINUTES TO GET THE BALLOON TO DEFLATE ENOUGH TO SAFELY REMOVE IT. DEFLATION ISSUES NOTED FOLLOWING FIRST INFLATION. NO ADDITIONAL INTERVENTION WAS NEEDED TO REMOVE DEVICE AND NO INJURY TO PATIENT. NO OTHER DIFFICULTIES ASIDE FROM SLOW DEFLATION. THE PHYSICIAN USED NEGATIVE PRESSURE ALONG WITH SYRINGE TO GET BALLOON TO INFLATE. THEN USED A DCB ON THE SAME LESION. THEY TRIED TO INFLATE IT ON THE TABLE OUTSIDE THE BODY AND PRODUCT HAD SAME PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15273520 ↗
• MalfunctionApr 1, 2022Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON CATHETER DURING PROCEDURE TO TREAT A LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE FIRST DEVICE. IT WAS REPORTED THAT DURING BALLOON INFLATION, BALLOON BURST, LEAK OR RUPTURE OCCURRED AT AN UNKNOWN ATM. ANOTHER NANOCROSS PTA BALLOON WAS ATTEMPTED AND BALLOON BURST, LEAK OR RUPTURE OCCURRED AT AN UNKNOWN ATM. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE BALLOONS WERE SAFELY REMOVED FROM PATIENT. THERE WAS NO VESSEL DAMAGE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13977079 ↗
• InjuryNov 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN INTENDED TO USE A NANOCROSS ELITE PTA BALLOON WITH A NON-MEDTRONIC 7FR SHEATH AND NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 40MM PLAQUE LESION IN THE PATIENT¿S PROXIMAL LEFT SUPERFICIAL FEMORAL ARTERY (SFA). ARTERY DIAMETER REPORTED AS 9MM. SLIGHT VESSEL CALCIFICATION AND TORTUOSITY ARE REPORTED. NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING PRIOR TO SUE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE PACKAGING. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. FOLLOWING USE OF THE BALLOON, IT IS REPORTED THAT EXCESSIVE FORCE WAS USED DURING WITHDRAWAL OF THE DEVICE AS THE PHYSICIAN FELT RESISTANCE AT THE SHEATH AND TUGGED. THIS RESULTED IN A DETACHMENT AT THE TIP WITH PART OF THE BALLOON REMAINING IN THE SHEATH. THE FRAGMENT DISLODGED AT THE ACCESS SITE AS EVERYTHING WAS REMOVED. ACCESS WAS GAINED ON THE OPPOSITE SIDE AND A SNARE WAS USED FOR REMOVAL OF THE DETACHED PORTION. NO FURTHER INJURY REPORTED.

  Patient problems: Injury

  MAUDE report 10815678 ↗

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,