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AtriCure cryoICE Cryoablation System (CRYO2)Recalls & reported problems

Atricure, Inc. · cryoICE 10cm Cryoablation Probe · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10840143902321), received between Jun 16, 2023 and Jun 16, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Activation Failure1

Patient problems

  • Respiratory Insufficiency1

Recent adverse event reports

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

  • MalfunctionJun 16, 2023Activation Failure

    ELDERLY MALE WITH CAD (CORONARY ARTERY DISEASE) AND NEW ONSET OF SOB (SHORTNESS OF BREATH). PROCEDURE: CABG X 2 (CORONARY ARTERY BYPASS GRAFT), MITRAL VALVE REPLACEMENT, MAZE AND LEFT ATRIAL APPENDAGE OCCLUSION. THE PROBE WAS INSIDE THE PATIENT AND DID NOT FREEZE WHEN USED. IT WAS REMOVED FROM THE PATIENT AND ATTEMPTED TO REACTIVATE OUTSIDE THE BODY AND WOULD NOT FREEZE. A NEW ONE OBTAINED AND FROZE WITHOUT ISSUES. NO KNOWN HARM TO PATIENT- DELAY IN PROCEDURE. MANUFACTURER RESPONSE FOR DEVICE, SURGICAL, CRYOGENIC, ATRICURE CRYOICE CRYOABLATION SYSTEM (CRYO2) (PER SITE REPORTER): WILL OBTAIN.

    Patient problems: Respiratory Insufficiency

    MAUDE report 17142629 ↗

Other Device, Surgical, Cryogenic devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.