Tank Hose Assembly (AtriCure) – Incorrect Supplier (2023)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
Brand
AtriCure, Inc.
Lot Codes / Batch Numbers
UDI-DI: 10840143903076, Lot Number: 129675
Products Sold
UDI-DI: 10840143903076; Lot Number: 129675
AtriCure, Inc. is recalling Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056 due to AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose ass. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026