NanoCross™ Elite AB14W060100150 (UDI 00821684067109)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684067109), received between Oct 1, 2018 and Jan 15, 2019 — classified as 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2019Burst Container or Vessel; Burst Container or Vessel

  THE PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS ELITE TO TREAT A SEVERELY CALCIFIED LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) . NO EMBOLIC PROTECTION WAS USED. A NON MEDTRONIC INFLATION DEVICE WAS USED TO INFLATE THE DEVICE. THE IFU WAS PREPPED WITH NO ISSUES REPORTED. THERE WAS NO DAMAGE TO THE DEVICE OR THE PACKAGING. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED AND NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT A BALLOON BURST OCCURRED WHEN THE DEVICE WAS INFLATED TO 8 ATM. ANOTHER NANACROSS DEVICE 6X150 WAS USED AND ALSO BURST WHEN INFLATED TO 8ATM (NOMINAL PRESSURE) AT AN AREA JUST BELOW WHERE THE FIRST BALLOON BURST. ALL FRAGMENTS OF THE BALLOONS WERE RETRIEVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8248393 ↗
• MalfunctionOct 1, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS ELITE BALLOON WITH A 6FR NON-MEDTRONIC GUIDEWIRE TO TREAT A MODERATELY CALCIFIED LESION WITH A MODERATE DEGREE OF TORTUOSITY IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE ARTERY DIAMETER WAS REPORTED AS 6MM WITH A LESION LENGTH OF 100M. THE BALLOON WAS REPORTED TO HAVE BEEN INFLATED USING A NON-MEDTRONIC INFLATION DEVICE. THE IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT WAS REPORTED THAT ONCE THE DEVICE WAS INFLATED IT WOULD NOT DEFLATE AT THE LESION SITE AND HAD DIFFICULTY BEING REMOVED FROM THE PATIENT. THE FORCE OF PULLING IT THROUGH THE SHEATH HELPED IT TO DEFLATE AND BE REMOVED. THE BALLOON DID NOT DEFLATE FULLY AT ANY POINT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7922570 ↗

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,