Health Canada Recalls Multiple Medical Devices Including One That May Cause Death

Health Canada has issued recalls for multiple medical devices, flagging concerns over potential risks to the most vulnerable patients. One such device under scrutiny is the OmniLab Advanced, commonly employed by individuals managing sleep apnea—a condition characterized by interrupted breathing during sleep.

According to the recall advisory, the OmniLab Advanced features an alarm system designed to alert users to internal errors or malfunctions in the ventilator mechanism. The agency specifies that products with certain lot numbers or bearing the model number 1044278 are subject to recall.

Reported issues range from intermittent device reboots to therapy interruptions, or even complete device failure, with or without prior reboots. Health Canada underscores that these malfunctions could lead to therapy discontinuity, potentially resulting in respiratory complications ranging from hypoventilation to severe hypoxemia, hypercarbia, or respiratory failure, ultimately posing a threat to the most vulnerable patients.

However, the OmniLab Advanced is not the sole device facing recall. Recent recalls, initiated last month, include multiple Medtronic cannulae products. Cannulae, slender tubes inserted into body cavities for various medical purposes, are among the affected products. The recall specifically addresses cardiac suction tubes, DLP cardiac vents and sumps, and Arteriotomy Cannulae due to concerns regarding potential sterility breaches.

Additionally, one lot of the Hugo Ras Surgeon Console, utilized for robotic assistance during surgeries, has been recalled due to 11 reported incidents of power loss from the main supply, which can result in the permanent inability to teleoperate the system from the surgeon console, either before or during surgical procedures.

Furthermore, several models of ophthalmic surgery procedure packs have been recalled due to heightened risks of inflammation and ocular tissue damage. Health Canada notes that the use of or exposure to the recalled products may lead to temporary or medically reversible adverse health consequences.

Health Canada has issued recalls for multiple medical devices, flagging concerns over potential risks to the most vulnerable patients. One such device under scrutiny is the OmniLab Advanced, commonly employed by individuals managing sleep apnea—a condition characterized by interrupted breathing during sleep.

According to the recall advisory, the OmniLab Advanced features an alarm system designed to alert users to internal errors or malfunctions in the ventilator mechanism. The agency specifies that products with certain lot numbers or bearing the model number 1044278 are subject to recall.

Reported issues range from intermittent device reboots to therapy interruptions, or even complete device failure, with or without prior reboots. Health Canada underscores that these malfunctions could lead to therapy discontinuity, potentially resulting in respiratory complications ranging from hypoventilation to severe hypoxemia, hypercarbia, or respiratory failure, ultimately posing a threat to the most vulnerable patients.

However, the OmniLab Advanced is not the sole device facing recall. Recent recalls, initiated last month, include multiple Medtronic cannulae products. Cannulae, slender tubes inserted into body cavities for various medical purposes, are among the affected products. The recall specifically addresses cardiac suction tubes, DLP cardiac vents and sumps, and Arteriotomy Cannulae due to concerns regarding potential sterility breaches.

Additionally, one lot of the Hugo Ras Surgeon Console, utilized for robotic assistance during surgeries, has been recalled due to 11 reported incidents of power loss from the main supply, which can result in the permanent inability to teleoperate the system from the surgeon console, either before or during surgical procedures.

Furthermore, several models of ophthalmic surgery procedure packs have been recalled due to heightened risks of inflammation and ocular tissue damage. Health Canada notes that the use of or exposure to the recalled products may lead to temporary or medically reversible adverse health consequences.

For more information, please refer to original notice posted by Global News.