NanoCross™ Elite AB14W060060150 (UDI 00763000110420)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000110420), received between Aug 28, 2020 and Feb 7, 2022 — classified as 1 injury, 2 malfunctions.

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

• InjuryFeb 7, 2022Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE NANOCROSS ELITE PTA BALLOON DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA) WITH CHRONIC TOTAL OCCLUSION (CTO-100%). THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL DIAMETER WAS 6MM. A NON-MEDTRONIC INFLATION BALLOON WAS USED FOR BALLOON INFLATION. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPER PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT BALLOON BURST/LEAK/RUPTURE OCCURRED DURING INFLATION AT 7ATM. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT PHYSICIAN SNARED TWO PIECES OF THE BROKEN BALLOON OUT OF THE BODY. THE BALLOON RUPTURED AFTER THE SECOND INFLATION INSIDE OF A STENT. EVERFLEX STENT WAS USED. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13470409 ↗
• MalfunctionFeb 1, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY WITH 80% STENOSIS. THE VESSEL WAS LITTLE TORTUOUS. NO EMBOLIC PROTECTION WAS USED. A NON-MEDTRONIC INFLATION DEVICE WAS USED TO INFLATE BALLOON. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. NEGATIVE PREP WAS PERFORMED. IT WAS REPORTED THAT DURING BALLOON INFLATION, THE BALLOON BURST/RUPTURE AT 6ATM. BALLOON LEAK WAS ALSO NOTED. IT IS UNKNOWN WHAT TYPE OF BALLOON BURST OCCURRED. THE BALLOON DID NOT FRAGMENT. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. THE LESION WAS LEFT ALONE. THERE WAS NO VESSEL DAMAGE NOTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11257086 ↗
• MalfunctionAug 28, 2020Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON DURING PROCEDURE TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA). A NON-MEDTRONIC INFLATION DEVICE WAS USED FOR BALLOON INFLATION. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING BALLOON INFLATION, BURST/LEAK/CATHETER LEAK WAS NOTED AT 8AM. ALL BALLOON FRAGMENTS WERE RETRIEVED FROM PATIENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10464585 ↗

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,