Product Wiki · Recalls · Health Canada — Medical Devices

Blower/Mister (2019-01-26) — recall 44531

Health Canada — Medical Devices · Canada · 2019-02-15 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
44531
Date of alert
2019-02-15
Country / jurisdiction
Canada
Authority classification
Type II
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/blowermister-2019-01-26

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