AtriCure cryoICE cryoSPHERE+ Cryoablation System CRYOSP-LRecalls & reported problems

Atricure, Inc. · Cryoablation Probe · Class 2

Data updated Oct 18, 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 10840143911736), received between Oct 29, 2025 and Oct 29, 2025 — classified as 1 malfunction.

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.

Reports received per month

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

Most reported problems

Device problems

Use of Device Problem1

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.

MalfunctionOct 29, 2025Use of Device Problem
DURING THE PROCEDURE THE CRYOABLATION MACHINE WAS NOT WORKING PROPERLY AND ACCORDING TO THE REP WHO WAS HANDLING THE MACHINE, THE ISSUE WAS THAT THE BOX WOULD NOT COMPLETELY DEFROST AFTER THE FIRST USE. IT WAS REBOOTED AND FUNCTIONED PROPERLY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23412815 ↗

Device details

UDI-DI	`10840143911736`
Brand	AtriCure cryoICE cryoSPHERE+ Cryoablation System
Model	CRYOSP-L
Catalog no.	A001448
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
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3 reports
AtriCure cryoICE cryoSPHERE Cryoablation System
Atricure, Inc. · Device, Surgical, Cryogenic
1 report
AtriCure cryoICE cryoSPHERE+ Cryoablation System
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1 report
AtriCure cryoICE Cryoablation System (CRYO2)
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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