Blower/Mister (2019-01-26)

Starting date:

January 26, 2019

Posting date:

February 15, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69050

• 
  Reason
• 
  Affected products

Affected Products

Blower/Mister

Reason

Maquet/Getingeis initiating a voluntary medical device removal for the AXIUS Blower Mister due to failure of the device to emit carbon dioxide (CO2) that may result in a procedural delay during off-pump coronary artery bypass (OPCAB). The AXIUS Blower Mister permits both an adjustable flow of gas and a mist of saline intended to clear an anastomic site for improved visibility.

The AXIUS Blower Mister was reported to not output a mist, which is an indication that carbon dioxide (CO2) did not flow through the device. There have been no adverse events reported resulting in serious illness or injuries caused by the AXIUS Blower Mister issue.

Affected products