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U.S. Department of Health and Human Services

Class 2 Device Recall AtriCure Cryo Module Accessories

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  Class 2 Device Recall AtriCure Cryo Module Accessories see related information
Date Initiated by Firm November 28, 2023
Date Posted January 31, 2024
Recall Status1 Open3, Classified
Recall Number Z-0928-2024
Recall Event ID 93672
510(K)Number K140058  
Product Classification Unit, cryosurgical, accessories - Product Code GEH
Product Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
Code Information UDI-DI: 10840143903076; Lot Number: 129675
Recalling Firm/
Manufacturer		 AtriCure, Inc.
7555 Innovation Way
Mason OH 45040-9695
For Additional Information Contact Scott Ehlert
513-755-4100
Manufacturer 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.
FDA Determined
Cause 2		 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 1
Distribution US Nationwide. Brazil, Canada, Japan, Taiwan
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GEH and Original Applicant = ATRICURE, INC.
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