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Health Canada recalls several medical devices, including one that could cause death – National | Globalnews.ca

Several medical devices have been recalled by Health Canada, including one which, according to the agency, could potentially cause the death of the most vulnerable patients.

This device is known as the OmniLab Advanced and is typically used by people suffering from sleep apnea, a condition in which affected individuals stop and start breathing while sleeping.

According to the recall notice, the OmniLab Advanced has an alarm to notify users when the device’s fan detects an error or internal problem. The agency says products from any lot are recalled or have model number 1044278.

Depending on the agency, this includes restarting the device intermittently, restarting processing, or even entering an inoperative state with or without a reboot.

Health Canada says any problems could “result in interruption and/or loss of treatment which may result in hypoventilation, mild to severe hypoxemia, hypercapnia, respiratory failure/failure or potentially death in the most vulnerable patients.”

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However, this is not the only medical device recalled.

Among the recalls, several of which began last month, are several Medtronic cannulas. A cannula is usually a thin tube inserted into a person’s body cavity, such as the nose or a vein, and is often used to drain fluid, administer medications, or provide oxygen or even blood.

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Some of these products include cardiac suction tubes, DLP cardiac vents and sumps, and arteriotomy cannulas. Health Canada says specific units are being recalled due to a possible sterility violation.

A list of the different serial and model numbers of Medtronic cannula products recalled by Health Canada.

Health Canada

A batch of Hugo Ras surgeon consoles, which can provide robotic assistance during surgical procedures, has been recalled due to 11 incidents of main power loss. This may result in a permanent loss of the ability to teleoperate the system from the surgeon’s console before or even during surgical procedures.

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Several models of ophthalmic surgery intervention packs have also been recalled.

The company has carried out a voluntary field correction of the medical device following a possible increased risk of inflammation and damage to ocular tissues. Health Canada says use or exposure to recalled products may cause temporary or medically reversible adverse health consequences.

Model numbers of Custom-Pak ophthalmic surgery procedure packs recalled by Health Canada.

Health Canada

Two models of paracervical/pudendal kits from Medline Industries and Lp were also recalled, due to the ring on the trumpet needle guide that could come loose under excessive pressure.

A list of models and lot numbers of paracervical/pudendal kits recalled by Health Canada.

Health Canada

In each case of a product recall, users of the products are advised to contact the manufacturer if additional information is required.

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