Arctic Front® 2AF234Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169504837), received between Sep 21, 2018 and Sep 21, 2018 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST CRYO ABLATION PROCEDURE, THE PATIENT HAD ATYPICAL CHEST PAIN FOR A FEW DAYS, WITH MILD SHORTNESS OF BREATH. ORAL MEDICATION WAS ADMINISTERED AND THE PATIENT'S HOSPITALIZATION WAS EXTENDED. THE CASE WAS ALREADY COMPLETED WITH CRYO. IT WAS NOTED THAT THE PATIENT'S SYMPTOMS THEN RESOLVED. THE PATIENT WAS PART OF THE (B)(6) STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Dyspnea

  MAUDE report 7898257 ↗

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