NanoCross™ Elite AB14W025040150 (UDI 00763000109608)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000109608), received between Apr 3, 2023 and Nov 14, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2023Burst Container or Vessel; Burst Container or Vessel

  TWO (2) NANOCROSS PTA BALLOONS WERE BEING USED FOR THE TREATMENT OF A CALCIFIED LESION WITH 80% STENOSIS IN THE PROXIMAL/MID REGION OF THE LEFT TIBIAL/POPLITEAL TRUNK (TPT). THE DEVICES WERE PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. AN INFLATION DEVICE WAS USED. IT WAS REPORTED THE BALLOONS BURST AT 14ATMS. THE BALLOONS HAD NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS MET DURING ADVANCEMENT. THE PHYSICIAN TRIED TO REMOVE WITH A SNARE. THEY WERE UNABLE TO REMOVE IN ONE PIECE AND DID NOT WANT TO BLOCK OFF THE AT SO THE PHYSICIAN DECIDED TO LEAVE THE BALLOON IN THE TPT. THE SAME ISSUE OCCURRED WITH THE SECOND BALLOON NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 18129111 ↗
• InjuryNov 14, 2023Burst Container or Vessel; Burst Container or Vessel

  TWO (2) NANOCROSS PTA BALLOONS WERE BEING USED FOR THE TREATMENT OF A CALCIFIED LESION WITH 80% STENOSIS IN THE PROXIMAL/MID REGION OF THE LEFT TIBIAL/POPLITEAL TRUNK (TPT). THE DEVICES WERE PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. AN INFLATION DEVICE WAS USED. IT WAS REPORTED THE BALLOONS BURST AT 14ATMS. THE BALLOONS HAD NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS MET DURING ADVANCEMENT. THE PHYSICIAN TRIED TO REMOVE WITH A SNARE. THEY WERE UNABLE TO REMOVE IN ONE PIECE AND DID NOT WANT TO BLOCK OFF THE AT SO THE PHYSICIAN DECIDED TO LEAVE THE BALLOON IN THE TPT. THE SAME ISSUE OCCURRED WITH THE SECOND BALLOON NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 18129097 ↗
• InjuryApr 3, 2023Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  A NANOCROSS PTA BALLOON WAS USED TO TREAT THE BTK (PERONEAL VESSEL). A NON MEDTRONIC INFLATION DEVICE WAS USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THE BALLOON WOULD NOT DEFLATE AT LESION SITE, HAD TO BURST THE BALLOON TO TRY AND GET IT TO FULLY DEFLATE. THERE WAS DIFFICULTY ENCOUNTERED WHEN REMOVING THE BALLOON FOLLOWING INFLATION, THE DISTAL PARTOF BALLOON STILL WOULD NOT DEFLATE. TRIED TO REMOVE THE BALLOON THRU A 6FR SHEATH THAT WAS IN PLACE AND IT WOULD NOT PULL THRU THE SHEATH, THE PHYSICIAN HAD TO REMOVE THE ENTIRE SHEATH AND BALLOON AND WAS REPLACED WITH A 7FR SHEATH. THE PHYSICIAN HAD TO DO A SMALL CUT DOWN IN ORDER TO REMOVE THE BALLOON FROM THE PATIENT. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16662471 ↗

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,