AtriCure cryoICE cryoSPHERE+ Cryoablation SystemRecalls & reported problems

Atricure, Inc. · Cryoablation Probe · Class 2

Data updated Oct 16, 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 10840143911729), received between Apr 3, 2026 and Apr 3, 2026 — classified as 1 malfunction.

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

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.

MalfunctionApr 3, 2026
ATRICURE CRYOPROBE (REF#CRYOSP, LOT162843) BLACK PROTECTIVE COVERING SHEARED INTO PATIENT AFTER BEING INSERTED INTO AN 8MM CANNULA PORT. USUALLY, A 12MM CANNULA PORT IS USED. IT IS BELIEVED THAT SHEARING OF BLACK PROTECTIVE COVERING OCCURRED DUE TO OPERATOR ERROR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24775711 ↗

Device details

UDI-DI	`10840143911729`
Brand	AtriCure cryoICE cryoSPHERE+ Cryoablation System
Model	CRYOSP
Catalog no.	A001447
Company	Atricure, Inc.
Product code	GXH · Device, Surgical, Cryogenic
Class	Class 2
FDA submission	K233170
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 23, 2024

Device type (GMDN): General cryosurgical system, cryogen gas, mechanical

An assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to malignant or abnormal benign tissue for its destruction and removal. The system typically includes a mechanical regulator to control the flow of cryogen, contained in an attached cylinder, and the probe(s) to apply the cold. The system is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) and is not dedicated to ophthalmic or cardiac use.

Other Device, Surgical, Cryogenic devices

AtriCure cryoICE cryoSPHERE Cryoablation System
Atricure, Inc. · Device, Surgical, Cryogenic
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AtriCure cryoICE cryoSPHERE+ Cryoablation System CRYOSP-L
Atricure, Inc. · Device, Surgical, Cryogenic
1 report
AtriCure cryoICE cryoSPHERE Cryoablation System
Atricure, Inc. · Device, Surgical, Cryogenic
1 report
AtriCure cryoICE Cryoablation System (CRYO2)
Atricure, Inc. · Device, Surgical, Cryogenic
1 report

All Device, Surgical, Cryogenic devices →

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 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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