Freezor® MAX 239F5Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169504899), received between Dec 7, 2016 and Dec 7, 2016 — 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.

• InjuryDec 7, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYOABLATION PROCEDURE, THE PATIENT EXPERIENCED ST ELEVATION. FIVE MINUTES LATER, ST ELEVATION DEPRESSED. IT WAS FURTHER REPORTED THAT THE RIGHT CORONARY ARTERY WAS SLIGHTLY SPASTIC. IV MEDICATION WAS ADMINISTERED AND THE CASE WAS CONTINUED. THE PATIENT¿S BLOOD PRESSURE FELL, HYPOKINESIA WAS NOTED DURING TREATMENT, AND AN ECHOCARDIOGRAM REVEALED ANOMALOUS PERICARDIAL EFFUSION. PERICARDIOCENTESIS WAS PERFORMED. THE PHYSICIAN WAS SUSPICIOUS OF PERFORATION OF THE LEFT ATRIUM. THE CASE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Perforation; Low Blood Pressure/ Hypotension; Low Cardiac Output; Pericardial Effusion; ST Segment Elevation

  MAUDE report 6153639 ↗

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