NanoCross™ Elite AB14W060150150 (UDI 00763000110505)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000110505), received between Apr 15, 2022 and Mar 4, 2024 — classified as 3 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.

• MalfunctionMar 4, 2024Burst Container or Vessel; Burst Container or Vessel

  A SPIDER FX AND NANOCROSS WAS USED FOR TREATMENT OF A 200MM CALCIFIED LESION WITH CHRONIC TOTAL OCCLUSION IN THE MID/DISTAL REGION OF THE LEFT SUPERFICIAL FEMORAL AND ARTERY POPLITEAL ARTERY. THE ARTERY WAS 6MM IN DIAMETER WITH MODERATE TORTUOSITY AND SEVERE CALCIFICATION. A 7FR NON MEDTRONIC SHEATH WAS USED AND A 0.014 SPIDER GUIDEWIRE. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE SPIDER KINKED DURING INITIAL ADVANCEMENT, THE DEVICE HAD BEEN GRIPPED AT THE DISTAL TIP. THE MARKERS AT THE DISTAL TIP WERE NO DEFORMED. ANOTHER 7MM SPIDER WAS USED. IT WAS REPORTED THE NANOCROSS DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. AN UNKNOWN INFLATION DEVICE WITH HEPRINIZED SALINE WAS USED FOR INFLATION. DURING THE FIRST INFLATION THE BALLOON RUPTURED AT 8 ATM. IT WAS REPORTED THAT THERE WERE NO FRAGMENTS. THE BALLOON WAS REMOVED AS A WHOLE FROM THE PATIENT BY PULLING THE BALLOON SLOWLY THROUGH THE SHEATH AND THERE WAS NO VESSEL DAMAGE NOTED. THE PROCEDURE WAS SUCCESSFU LLY COMPLETED WITH A NEW NANOCROSS PTA BALLOON. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18827473 ↗
• MalfunctionAug 21, 2023Leak/Splash; Leak/Splash

  A PHYSICIAN WAS USING A NANOCROSS ELITE DURING THE TREATMENT OF A CALCIFIED LESION WITH 30% STENOSIS IN THE PROXIMAL REGION OF THE SUPERFICIAL FEMORAL ARTERY. THERE WAS MILD TORTUOSITY AND SEVERE CALCIFICATION. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED DURING THE 5TH INFLATION AT 10 ATM A PINHOLE LEAK OCCURRED. A SECOND NANOCROSS BALLOON ALSO BURST AT 8 ATM ON THE 1ST INFLATION, BUT WAS ABLE TO KEEP THE BALLOON UP FOR 1 MINUTE OF ANGIOPLASTY, THE PHYSICIAN DECIDED NOT TO TRY ANOTHER BALLOON. ALL FRAGMENTS WERE RETRIEVED. UPON REMOVING THE BALLOON FROM THE SHEATH AND PATIENT THE PROVIDER AND TECH CONFIRMED ON THE BACK TABLE THAT ALL FRAGMENTS OF THE BALLOON REMAINED INTACT AND NO FRAGMENTS WERE LEFT IN PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17582200 ↗
• MalfunctionApr 15, 2022Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  PHYSICIAN WAS ATTEMPTING TO USE THE NANOCROSS ELITE PTA BALLOON DURING PROCEDURE TO TREAT MODERATELY CALCIFIED LESION IN THE PROXIMAL LEFT SUPERFICIAL FEMORAL ARTERY(SFA).THE VESSEL HAD LITTLE TORTUOSITY AND EXHIBITED 80% STENOSIS. THE ARTERY DIAMETER WAS 6MM AND LESION LENGTH WAS 60MM.A 6FR SHEATH AND NON-MEDTRONIC GUIDEWIRE WERE USED. THE BALLOON WAS INFLATED WITH A NON-MEDTRONIC INFLATION DEVICE. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E., SHELF CARTON, HOOP/TRAY AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. NO DAMAGE WAS NOTED TO THE BALLOON CATHETER. NO KINKS WERE NOTED IN BALLOON CATHETER OR WIRE. IT WAS REPORTED THAT BOTH INFLATION AND DEFLATION ISSUES WERE NOTED. BALLOON PARTIALLY INFLATED THEN WOULDN¿T DEFLATE. THERE WERE BALLOON INFLATION DIFFICULTIES AT 8ATM. IT WAS REPORTED THAT THERE WERE BALLOON DEFLATION DIFFICULTIES. DEVICE WOULD NOT DEFLATE AT THE LESION SITE. DEFLATION ISSUES NOTED FOLLOWING FIRST INFLATION. DEFLATION ISSUES NOTED DURING SUBSEQUENT INFLATION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT TOOK 15 MINUTES OF BACKWARD PRESSURE TO GET BALLOON DEFLATED ENOUG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117274 ↗

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,