Cryo Module Tank Hose Assemblies Recalled for Material and Design Defects
AtriCure recalls certain tank hose assemblies for Cryo Module equipment due to manufacturing defects. The units have incorrect inner tube material and missing required perforations on the outer sheathing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with manufacturing specification defects. No illnesses, injuries, or deaths have been reported. The defect represents a theoretical risk of equipment malfunction rather than documented harm, qualifying as High severity per the rubric.
Plain-English summary
AtriCure, Inc. is recalling certain tank hose assemblies for use in Cryo Module cryosurgical equipment. Affected units include Catalog Number A001053 from 10 specific lot numbers and were distributed to customers in the United States, Brazil, Canada, Japan, and Taiwan.
The manufacturer identified that a second-tier supplier provided tank hose assemblies that do not meet required specifications. Specifically, the outer sheathing lacks required pin perforations, and the inner tube is manufactured from incorrect material.
A total of 35 affected units from the identified lot numbers are part of this recall.
The recalled product
- Product
- Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
- Manufacturer
- AtriCure, Inc.
- Hazard
- material-defect
- specification-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- UDI-DI: 10840143903038
- Lot Numbers: 129673
- 129674
- 129882
- 130314
- 130750
- 131614
- 132669
- 133672
- 133673
- 134270
Distribution
Distributed nationwide across the United States.
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