Medical Device Recall: Potential Death Risk for Patients with OmniLab Advanced and Other Devices recalled by Health Canada

Toronto, Canada – Health Canada has issued recalls for several medical devices, raising concerns about potential risks to patients. One of the devices in question is the OmniLab Advanced, primarily used for individuals with sleep apnea, a condition characterized by interrupted breathing during sleep. The agency warns that the device’s ventilator may experience internal errors, leading to interruptions in therapy that could pose serious health risks, including respiratory failure or death in vulnerable patients.

Alongside the OmniLab Advanced, Health Canada has also recalled multiple Medtronic cannulae products due to a potential sterility breach. These products, such as cardiac suction tubes and Arteriotomy Cannulae, are used in various medical procedures to drain fluids or administer medications. The agency advises that exposure to the recalled products may result in temporary or reversible adverse health effects.

Additionally, the Hugo Ras Surgeon Console, a device that provides robotic assistance during surgeries, has been recalled due to incidents of power loss, which could prevent proper teleoperation during surgical procedures. Moreover, various models of ophthalmic surgery procedure packs have also been subject to recalls due to potential risks of inflammation or ocular tissue damage.

Furthermore, paracervical/pudendal kits from Medline Industries and Lp have been recalled after concerns about the detachment of a ring on the trumpet needle guide under excessive pressure. Health Canada emphasizes the importance of contacting the manufacturer for additional information for those who have used these recalled products.

In light of these recalls, patients and healthcare providers are urged to remain vigilant and reach out to the respective manufacturers for guidance on the next steps. These incidents highlight the critical importance of stringent safety measures in the medical device industry to safeguard patient well-being.