Recall Z-0927-2024 ยท GEH Unit, Cryosurgical, Accessories
AtriCure, Inc.
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
| Date | Jan 31, 2024 (initiated Nov 28, 2023) |
| Status | Open, Classified |
| 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 assembli |
| Quantity | 35 |
| Distribution | US Nationwide. Brazil, Canada, Japan, Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140058 | ATRICURE CRYO MODULE SYSTEM AtriCure, Inc., Jan 24, 2014 |