AtriCure cryoICE cryoSPHERE Cryoablation System (REF A001009)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10840143902543), received between Aug 31, 2022 and Jan 4, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryJan 4, 2024Use of Device Problem; Use of Device Problem

  ON (B)(6) 2023 A MALE PATIENT UNDERWENT A VIDEO-ASSISTED THORACOSCOPIC NUSS PROCEDURE WITH CONCOMITANT CRYO NERVE BLOCK USING A CRYOS PROBE. DURING PROCEDURE, SURGEON RELEASED THE LUNG FOLLOWING A FREEZE APPLICATION. THE CRYOS PROBE ADHERED TO LUNG TISSUE DURING REMOVAL. AS A PRECAUTION, THE SURGEON DID WEDGE RESECTION OF THE PORTION OF LUNG TISSUE THAT ADHERED TO THE PROBE, IN ORDER TO PREVENT A POSSIBLE DELAYED PNEUMOTHORAX. THERE WAS NO CONFIRMED DEVICE MALFUNCTION, AND THIS EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Cryogenic Burn

  MAUDE report 18443015 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, A PATIENT UNDERWENT A PECTUS REPAIR WITH CRYO NERVE BLOCK. TISSUE NEAR THE INCISION SITE CAME IN CONTACT WITH THE CRYOS PROBE AND DISCOLORED. SURGEON ELECTED TO EXCISE THIS TISSUE. THE PROCEDURE WAS COMPLETED, AND THERE WERE NO ADDITIONAL REPORTED COMPLICATIONS WITH THE PATIENT. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Cryogenic Burn

  MAUDE report 16147070 ↗
• InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022 THAT A MALE PATIENT UNDERWENT AN OFF-PUMP, NUSS / CRYO-NERVE BLOCK (CNB) PROCEDURE. DURING THE CNB, THE PHYSICIAN NOTICED AN AREA OF FROSTBITE ON THE PATIENT'S SKIN. THE IMPACTED SKIN WAS EXCISED. POST PROCEDURE, PATIENT WAS DOING WELL. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.

  Patient problems: Cryogenic Burn

  MAUDE report 15331399 ↗