FDA Medical Device Recalls (openFDA)
AtriCure, Inc.: Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
- Recall number
- Z-0928-2024
- Recalling firm
- AtriCure, Inc.
- Product
- Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
- Status
- Open, Classified
- Initiated
- 2023-11-28
- Posted
- 2024-01-31
- Terminated
- not on file
- Reason
- 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
- 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
- 1
- Distribution
- US Nationwide. Brazil, Canada, Japan, Taiwan
- Lot, serial or model codes
- UDI-DI: 10840143903076; Lot Number: 129675
- 510(k) numbers
- ["K140058"]
- PMA numbers
- not on file
- Product code
- GEH
- Firm FEI
- 3011706110
- Firm city
- Mason
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28