Maquet Cardiovascular Recalls AXIUS Blower Mister Due to CO2 Flow Issues
Maquet Cardiovascular is recalling AXIUS Blower Mister devices because a potential lack of carbon dioxide flow may cause procedural delays during off-pump coronary artery bypass surgery.
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: The recall is classified as FDA Class II. The hazard involves a potential lack of CO2 flow causing procedural delays, which is a risk-of-harm product issue where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the AXIUS Blower Mister (Product Code CB-1000). The device is intended to clear an anastomotic site for improved visibility during off-pump coronary artery bypass (OPCAB) procedures.
The recall is due to a potential lack of carbon dioxide (CO2) flow, which may result in a procedural delay during surgery. The recall involves 7,880 units (1,576 packs of 5) distributed worldwide, including the United States, Australia, Belgium, Canada, the Czech Republic, France, Germany, Korea, the Netherlands, Russia, Spain, Switzerland, and the United Kingdom. Affected lot numbers are 96255605, 96255607, 96255608, 96255609, and 96255611.
Healthcare facilities should stop using the affected devices and contact Maquet Cardiovascular for instructions on how to return or dispose of them.
The recalled product
- Product
- AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility
- Manufacturer
- Maquet Cardiovascular, LLC
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 (5)
- Lot Numbers: 96255605
- 96255607
- 96255608
- 96255609
- 96255611 UDI: 20607567700745
Distribution
Distributed nationwide across the United States.
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