Maquet Cardiovascular, LLC: Medical Device Recall in 2019 - (Recall #: Z-0983-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 24, 2019

Date Posted: March 13, 2019

Recall Number: Z-0983-2019

Event ID: 82090

Reason for Recall:

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

Status: Terminated

Product Quantity: 7,880 each (1,576 packs of 5)

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.

Voluntary or Mandated:

Voluntary: Firm initiated