Tank hose assembly recalled for incorrect material and missing perforations
AtriCure recalls tank hose assemblies due to manufacturing defects. Certain lots have outer sheaths missing required pin perforations and inner tubes made of incorrect material.
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 component with structural defects (missing pin perforations, incorrect material composition). No illnesses or injuries have been reported. The defect presents a risk of functional failure or device malfunction without documented patient harm, meeting the threshold for High severity.
Plain-English summary
AtriCure, Inc. is recalling certain lots of the Tank Hose Assembly CMA-US (Product Catalog Number A001056). These assemblies were provided by a second-tier supplier with manufacturing defects.
The recalled tank hose assemblies have two defects: the outer sheathing lacks the required pin perforations, and the inner tube is made from incorrect material. These structural defects could affect the functionality and safe operation of the assembly.
The affected product was distributed nationwide in the United States, as well as to Brazil, Canada, Japan, and Taiwan. Lot Number 129675 is included in this recall.
Customers should cease use of affected units and contact AtriCure for instructions on replacement or disposal.
The recalled product
- Product
- Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
- Manufacturer
- AtriCure, Inc.
- Hazard
- manufacturing-defect
- material-defect
- component-failure-risk
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 (2)
- UDI-DI: 10840143903076
- Lot Number: 129675
Distribution
Distributed nationwide across the United States.
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