NanoCross™ Elite AB14W060150150 (UDI 00821684067147)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821684067147), received between Mar 15, 2017 and May 24, 2019 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 24, 2019Burst Container or Vessel; Burst Container or Vessel

  YES

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8639688 ↗
• InjuryApr 10, 2018Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN INTENDED TO USE THE NANOCROSS ELITE TO TREAT A CTO IN THE RIGHT PROXIMAL POPLITEAL AS PER IFU. THE ARTERY DIAMETER WAS REPORTED AS 6MM. THE LESION LENGTH WAS 150MM AND DESCRIBED AS SEVERELY CALCIFIED <(>&<)> SEVERELY TORTUOUS. A NON-MEDTRONIC BALLOON WAS INFLATED IN THE LESION BUT THE BALLOON BURST. THE PHYSICIAN THEN ATTEMPTED TO USE THE NANOCROSS BALLOON. WHEN IT HAD CROSSED THE LESION THE BALLOON WAS INFLATED TO 8-10ATM BUT THE BALLOON BURST. THE BALLOON WAS THEN DEFLATED BUT BECAME STUCK ON THE WIRE ON REMOVAL. THE BALLOON AND THE WIRE WERE REMOVED AS A UNIT, DURING WHICH THE BALLOON HAD STRETCHED AND CAME APART IN THE SHEATH. A GOOSENECK SNARE WAS USED TO REMOVE THE BLUE BALLOON SHAFT AND PART OF THE BALLOON. THE PROCEDURE WAS FINISHED WITH A NON-MEDTRONIC PTA BALLOON.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7412846 ↗
• InjuryApr 5, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A NANOCROSS ELITE WITH A NON-MDT 7 FR SHEATH AND NON-MDT 0.14 300 MM GUIDEWIRE FOR TREATMENT OF A SEVERELY CALCIFIED CTO (CHRONIC TOTAL OCCLUSION-100%) 175 MM LESION IN THE PATIENTS LEFT PROXIMAL COMMON FEMORAL ARTERY (DIAMETER 6 MM)AND EXTERNAL ILIAC ARTERY (DIAMETER 7-8 MM). IT WAS REPORTED THAT UPON COMPLETION OF THE FIRST INFLATION, TO 12 ATM, OF THE BALLOON IN THE COMMON FEMORAL ARTERY, THE BALLOON BURST. THE PHYSICIAN NOTED THE BURST AND GAVE TIME FOR THE DEVICE TO DEFLATE ON ITS OWN. UPON ATTEMPTING TO WITHDRAW THE DEVICE, RESISTANCE WAS NOTED, THE BALLOON WOULD NOT WITHDRAW. IT WAS REPORTED THAT THE PHYSICIAN PULLED BACK MULTIPLE TIMES, UNSUCCESSFULLY, TO WITHDRAW THE BALLOON. THE PHYSICIAN THEN CUT AND REMOVED THE EXTERNAL JIBBED PORTION OF THE BALLOON SHAFT WITH ONLY THE INTERNAL (THIN BLUE COLOURED PORTION) EXPOSED AND ATTACHED TO THE BALLOON STILL INSIDE THE PATIENT, THROUGH THE SHEATH OVER THE WIRE. THE PHYSICIAN REMOVED THE 7 FRENCH SHEATH AND CONTINUED TO ATTEMPT REMOVAL OF THE BALLOON OVER THE WIRE. THE BALLOON EVENTUALLY BECAME DETACHED FROM SHAFT WITH THE SHAFT BEING REMOVED OVER THE WIRE AND THE ELITE BALLOON BUN

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7399555 ↗
• MalfunctionMar 15, 2017Deflation Problem; Deflation Problem

  A NANOCROSS ELITE BALLOON WAS USED TO PERFORM A BALLOON ANGIOPLASTY PROCEDURE OF A CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). IT WAS REPORTED THAT PHYSICIAN ENCOUNTERED DIFFICULTY IN DEFLATING THE BALLOON AND REMOVING IT. IT WAS REPORTED THE BALLOON WAS PINCHED JUST DISTAL TO THE MID-MARKER, AND IT BECAME TWISTED. THERE WAS DIFFICULTY IN UN-WRAPPING THE BALLOON. IT TOOK SEVERAL MINUTES AND SEVERAL SYRINGES TO MAKE THE BALLOON DEFLATE. PHYSICIAN EVENTUALLY GOT THE BALLOON OUT OF THE VESSEL. NO INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6408540 ↗

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,