Freezor® MAX 239F3Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169504905), received between Jun 9, 2017 and Jun 27, 2019 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRIOR TO A CRYO ABLATION PROCEDURE, ST ELEVATION WAS OBSERVED. MEDICATION WAS ADMINISTERED WITH RESOLVE. THE CASE WAS COMPLETED WITH CRYO. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: ST Segment Elevation

  MAUDE report 8741162 ↗
• InjuryFeb 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, THE PATIENT EXPERIENCED A "DROP IN ST LEVEL". CORONARY ANGIOGRAPHY (CAG) INDICATED THAT THERE WAS NO STENOSIS, BUT THE CONTRAST MEDIA DID NOT FLOW NORMALLY. NITROGLYCERIN WAS THEN ADMINISTERED WITH RESOLVE. IT WAS NOTED THAT THE ST DEPRESSION RECOVERED. THE CASE WAS COMPLETED WITH CRYO. HOSPITALIZATION WAS NOT EXTENDED AS A RESULT OF THE EVENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: ST Segment Depression

  MAUDE report 7245636 ↗
• InjuryJun 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A COMPLETED CRYO ABLATION PROCEDURE USING AN ELECTROPHYSIOLOGY (EP) CATHETER AND A COMPETITOR CATHETER, THE PATIENT¿S BLOOD PRESSURE DECLINED AND A PERICARDIAL EFFUSION WAS CONFIRMED. DRAINAGE WAS PERFORMED. IT WAS FURTHER REPORTED THAT THE PATIENTS CONDITION WAS ¿GOOD¿. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 6630209 ↗

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