Z-0927-2024Class II

Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053

Name: Z-0927-2024 Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
Creator: AtriCure, Inc.
Published: 2023-11-28
License: https://open.fda.gov/license/

AtriCure, Inc. / initiated 2023-11-28 / Open, Classified / root cause: supplier

FDA source

AtriCure, Inc. began a recall of Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053 on 2023-11-28. FDA classified it as Class II and gives the reason as "AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-0927-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-28
Posted: 2024-01-31
Recalling firm: AtriCure, Inc.
Product: Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
Product code: GEH Unit, Cryosurgical, Accessories
Reason for recall: AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations and the inner tube of the hose is not the correct material.
Root cause tag: supplier
FDA root cause: Other
Action: An URGENT: MEDICAL DEVICE RECALL notification letter dated 11/28/23 was sent to customers. Actions to be taken by the Customer/User: " If the Tank Hose assembly is part of the lots listed below, do not use the tank hose assembly. " If the lot number is listed below, work with your AtriCure sales rep to replace the device with a new Tank Hose assembly and return the recalled device. " Return the attached Medical Device Recall Return Response Acknowledgement and Receipt Form. Type of Action by the Company: AtriCure is arranging for the removal and replacement of the affected tank hose assemblies. If you have impacted product, AtriCure will provide a replacement product at no charge to you. If you have any questions, please contact Rob Cantu, Vice President of Quality at (1-513-755-4100) from 9-5pm ET on Mondays - Fridays. You may also contact customer service at (1-866-349-2342) any time of day, your message will be forwarded to Quality Assurance for prompt review.
Quantity in commerce: 35
Distribution: US Nationwide. Brazil, Canada, Japan, Taiwan
Product codes and lots: UDI-DI: 10840143903038; Lot Numbers: 129673, 129674, 129882, 130314, 130750, 131614, 132669, 133672, 133673, 134270

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0927-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0927-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-31
Z-0928-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-31

Product code GEH

K140058Class IIAtricure Cryo Module SystemAtriCure, Inc. / cleared 2014-01-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)