AtriCure cryoICE cryoSPHERE Cryoablation System (REF A001009)Recalls & reported problems
Atricure, Inc. · CRYOS, Packaged Assembly · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00818354016321), received between Jul 7, 2022 and Jul 7, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Crack” (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
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 7, 2022Crack; Crack
ON (B)(6) 2021 WHEN PREPARING FOR A MODIFIED PECTUS EXCAVATUM PROCEDURE, THE CRYOS PROBE WAS CONNECTED TO THE ACM GENERATOR, LAID ON A TABLETOP AND A TEST FREEZE WAS INITIATED. WHEN THE PROBE REACHED -40 DEGREES, THE ACM COUNTED DOWN FOR ABOUT 10 SECONDS AND THEN SCRUB TECHNICIAN VENTED IT BY PRESSING THE N2O MANUAL EXHAUST KNOB. WHEN DOING THIS A LOUD "POP" SOUND OCCURRED AND THE DEVICE HANDLE SEPARATED. THERE WAS NO PATIENT HARM. DURING DEVICE EVALUATION, IT WAS OBSERVED THAT THE EXHAUST CRIMP SLEEVE WAS NOT PRESENT IN THE DEVICE. THIS DISCOVERY ESCALATED THIS PRODUCT PROBLEM TO A REPORTABLE EVENT PER PART 803 ON (B)(6) 2022.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14950614 ↗
Other Device, Surgical, Cryogenic devices
- AtriCure cryoICE cryoSPHERE Cryoablation SystemAtricure, Inc. · Device, Surgical, Cryogenic3 reports
- AtriCure cryoICE cryoSPHERE+ Cryoablation SystemAtricure, Inc. · Device, Surgical, Cryogenic1 report
- AtriCure cryoICE cryoSPHERE+ Cryoablation System CRYOSP-LAtricure, Inc. · Device, Surgical, Cryogenic1 report
- AtriCure cryoICE Cryoablation System (CRYO2)Atricure, Inc. · Device, Surgical, Cryogenic1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page