Arctic Front Advance™ 2AF234 (UDI 00763000341473)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000341473), received between Jul 13, 2021 and Oct 15, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Body Fluid” (1 report).

1 other recall cover devices cleared under the same FDA submission (P100010); 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 16, 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.

• MalfunctionOct 15, 2024Excessive Cooling; Infusion or Flow Problem; Excessive Cooling; Infusion or Flow Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, FROST WAS SEEN ON THE COAXIAL UMBILICAL CABLE TO CATHETER CONNECTION. THE COAXIAL UMBILICAL CABLE WAS REPLACED WHICH RESOLVED THE ISSUE. IT WAS ALSO REPORTED THAT THE TEMPERATURES WERE COLDER, QUICKER THAN EXPECTED AND THE BALLOON CATHETER THAWED MORE QUICKLY THAN EXPECTED. THE BALLOON CATHETER WAS REPLACED WHICH RESOLVED THE ISSUE. THE CASE WAS COMPLETED WITH CRYO. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20455807 ↗
• MalfunctionJul 13, 2021Device Contamination with Body Fluid; Material Integrity Problem; Device Contamination with Body Fluid; Material Integrity Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, BLOOD WAS SEEN IN THE COAXIAL UMBILICAL CABLE AND BALLOON CATHETER CONNECTION. THE BALLOON CATHETER AND COAXIAL UMBILICAL CABLE WERE REPLACED WHICH RESOLVED THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159285 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100010. One submission often covers many models, so check the product and lot details in each record.

• Z-0149-2012 · Aug 29, 2011 · Terminated
  Medtronic Arctic Front Catheter, Sterile EO, Medtronic CryoCath LP, Kirkland, Quebec, H9H 5 H3, Canada, Model 2AF282 and 2AF231 ( not distributed in US) Product Usage: The Medtr