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Recall Observatory FDA recall evidence

Device product

AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility

Z-0983-2019

January 24, 2019

Class II

Product summary

Firm
Maquet Cardiovascular, LLC
Event
Event 82090
Status
Terminated
Classification
Class II
Quantity
7,880 each (1,576 packs of 5)
Official record key
device-enforcement:Z-0983-2019

Official wording

Reason: Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).

Code information: Lot Numbers: 96255605,96255607,96255608,96255609,96255611 UDI: 20607567700745

Distribution pattern: Worldwide distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, France, Germany, Korea, Netherlands, Russia, Spain, Switzerland, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).