AtriCure, Inc. 2024-02-07 Health serious FDA
Health · FDA · Recall #FDA-Z-0927-2024
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053 Recall
Issued February 7, 2024 · AtriCure, Inc.
In February 2024, AtriCure, Inc. recalled the Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact AtriCure, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- AtriCure, Inc.
- Category
- Health
- Recall date
- February 7, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide. Brazil, Canada, Japan, Taiwan
- Recall number
- FDA-Z-0927-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- AtriCure, Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.