NanoCross™ Elite AB14W040080150 (UDI 00763000110123)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000110123), received between Sep 20, 2022 and May 11, 2023 — 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.

• InjuryMay 11, 2023Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  A NANOCROSS PTA BALLOON WAS BEING USED FOR THE TREATMENT OF A CALCIFIED LESION WITH 99% STENOSIS IN THE LEFT DISTAL REGION OF THE POPLITEAL ARTERY SUPERFICIAL FEMORAL ARTERY. THERE WAS MILD TORTUOSITY AND MODERATE CALCIFICATION. A 0.014" NON MEDTRONIC GUIDEWIRE WAS USED. EMBOLIC PROTECTION WAS NOT USED. THE NANOCROSS WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE BALLOON DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE. IT WAS REPORTED AFTER ONE PRIOR INFLATION THE BALLOON BURST PRIOR TO REACHING NOMINAL PRESSURE (1-7ATM). THE BALLOON CATHETER WOULD NOT ADVANCE OFF THE WIRE AFTER THE BURST AND IT APPEARED TO SNAP OFF AT THE DISTAL PORTION LEAVING THE BALLOON AND A PORTION OF THE CATHETER IN THE PATIENTS VESSEL. THE DISTAL CATHETER AND BALLOON WERE JAILED IN THE VESSEL WITH A GORE VIABAHN STENT. NO FURTHER PATIENT INJURY REPORTED FOR THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 16911678 ↗
• MalfunctionNov 27, 2022Burst Container or Vessel; Burst Container or Vessel

  A PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON CATHETER FOR THE TREATMENT OF A CALCIFIED LESION IN THE DISTAL REGION OF T HE POPLITEAL ARTERY. THERE WAS MILD TORTUOSITY AND MODERATE CALCIFICATION. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. AN EVEREST INFLATION DEVICE WAS USED FOR BALLOON INFLATION. IT WAS REPORTED THAT THE BALLOON BURST/ LEAKED AT 6 ATM.  ALL FRAGMENTS WERE RETRIEVED. A LIKE-SIZED BALLOON WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15867170 ↗
• MalfunctionSep 20, 2022Burst Container or Vessel; Burst Container or Vessel

  IT IS REPORTED THAT DURING A PROCEDURE TO TREAT A CALCIFIED EXTERNAL ILIAC TWO BALLOONS BURST OCCURRED. AN EVERCROSS BALLOON BURST BEFORE 20ATM AND A NANOCROSS BALLOON BURST BEFORE 14ATM. NO DAMAGE NOTED TO PACKAGING. NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. DEVICE WAS PREPPED PER THE IFU. DEVICE WAS INFLATED WITH AN EVEREST ENDOFLATOR. 3:1 SALINE TO CONTRAST INFLATION FLUID USED. NO EMBOLIC PROTECTION USED. ISSUE OCCURRED ON FIRST INFLATION. ALL FRAGMENTS OF THE BALLOON RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL TREATMENT REQUIRED. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15453631 ↗

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,