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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 1
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.
Part of a larger recall action
This product is one of 2 recalled by AtriCure, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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