NanoCross™ Elite AB14W025150150 (UDI 00763000109707)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000109707), received between Mar 31, 2021 and Jul 22, 2024 — classified as 1 injury, 3 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2024Burst Container or Vessel; Burst Container or Vessel

  A NANOCROSS ELITE PTA BALLOON WAS BEING USED FOR TREATMENT OF A 150MM CALCIFIED LESION WITH 100% STENOSIS IN THE PROXIMAL REGION OF THE RIGHT POSTERIOR TIBIAL ARTERY. THE ARTERY WAS 2.5MM IN DIAMETER WITH MINIMAL TORTUOSITY AND SEVERE CALCIFICATION. A 6FR NON MEDTRONIC SHEATH AND A 0.014" NON MEDTRONIC GUIDEWIRE WAS USED. THE VESSEL WAS NOT PRE-DILATED. THE IFU WAS FOLLOWED. THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM PACKAGING. MODERATE RESISTANCE WAS MED WHEN ADVANCING THE DEVICE. A NON MEDTRONIC INFLATION DEVICE WITH 50/50 CONTRAST WAS USED FOR INFLATION. IT WAS REPORTED ON THE FIRST INFLATION THE BALLOON BURST AT 10 ATM. THE BALLOON DID NOT DETACH. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. ANOTHER NANOCROSS WAS USED WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19792604 ↗
• MalfunctionJun 13, 2024Leak/Splash; Leak/Splash

  PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON WITH A 6FR NON-MEDTRONIC SHEATH AND A 014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 150MM PLAQUE LESION IN THE PATIENTS RIGHT MID TIBIAL/POPLITEAL TRUNK <(>&<)> ANTERIOR TIBIAL ARTERY. MINIMAL VESSEL TORTUOSITY AND MINIMAL VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED 30% STENOSIS. ARTERY DIAMETER REPORTED AS 2.5MM. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT PRE OR POST DILATED. AN INFLATION DEVICE WAS USED FOR BALLOON INFLATION. 50/50 CONTRAST INFLATION FLUID WAS USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. IT WAS REPORTED THAT A BALLOON LEAK WAS REPORTED DURING THE PROCEDURE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. A REPLACEMENT NON-MEDTRONIC DEVICE WAS USED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528200 ↗
• InjuryDec 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  LIMITED INFORMATION REPORTS A PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON CATHETER DURING PATIENT TREATMENT AND A DEVICE COMPONENT DETACHED, CRACKED, OR FRACTURED. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THE DETACHED PORTION OF DEVICE DOES NOT REMAIN IN PATIENT. THE DETACHED PORTION OF DEVICE WAS SNARED AND REMOVED VIA GROIN OPEN SURGERY TO COMPLETE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18345006 ↗
• MalfunctionMar 31, 2021Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE NANOCROSS BALLOON CATHETER ALONG WITH A NON-MEDTRONIC 6FR SHEATH AND NITREX 0.014" GUIDEWIRE DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT MID POSTERIOR TIBIAL ARTERY (PTA) AND ANTERIOR TIBIAL ARTERY (ATA) WITH 95% STENOSIS. THE VESSEL WAS LITTLE TORTUOUS. THE VESSEL DIAMETER AND LESION LENGTH ARE 2.5MM AND 140MM RESPECTIVELY. A NON-MEDTRONIC INFLATION DEVICE WAS USED. A 60/40 CONTRAST/SALINE WAS USED FOR INFLATION FLUID. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING SECOND BALLOON INFLATION A BURST/LEAK/RUPTURE OCCURRED AT 9ATM. 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. ANOTHER 2.5X150 NANOCROSS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11595735 ↗

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,