It has been confirmed that Medtronic Korea is conducting a manufacturer's recall of its laryngoscope blade, McGRATH MAC 2-Blade, from domestic medical institutions.

According to the Ministry of Food and Drug Safety (MFDS), Medtronic Korea is recalling 500 units with specific manufacturing numbers. Under the company’s plan submitted to the ministry, the recall period is about one month, from Aug. 14 to Sept. 14.

"We are requesting and monitoring the company to finalize the recall within the recall period quickly," the ministry said.

Laryngoscope blades, or "laryngoscopes," are medical devices for airway clearance and endotracheal intubation. The ongoing recall was in response to complaints of poor image quality and blurred images on the video laryngoscope screen when foreign medical professionals used the McGRATH MAC 2-Blade.

The company's investigation confirmed that the anti-fog agent was not effectively applied to the blades during production, resulting in an inadequate application of the anti-fog coating. If the anti-fog coating is not properly applied, condensation can accumulate on the blades, potentially blurring the image on the video laryngoscope screen.

That can result in a blurred image on the video laryngoscope screen, which, in turn, can lead to multiple intubation attempts, potentially increasing the risk of oral tissue damage and bleeding and prolonging the intubation process, which can lead to hypoxia and respiratory failure.

In reality, some cases have been reported overseas where searching for alternative devices resulted in delays in treatment or damage to oral tissue due to multiple intubation attempts.

Medtronic Korea has decided to immediately recall the affected product (model number 350-017-000, manufacturer number 22083101) and provide a replacement. The company is notifying all healthcare organizations that have received the affected products in a letter and is conducting a recall.

"There have been no reports of injuries or deaths of patients in Korea due to this issue,” a Medtronic Korea official said. “To prevent the use of McGRATH MAC 2 blades that could potentially affect patients, we initiated a voluntary retailer recall in August 2023, whereby retailers are asked to take back any unused inventory."

The official went on to say, “The quality and safety of Medtronic products is our top priority. From design, development, manufacturing, distribution, and patient use, we continually improve and implement processes and protocols to ensure quality, reliability, and compliance."

The official emphasized that this recall is also a voluntary decision in the interest of quality and safety, and we are implementing communications, corrective actions, or troubleshooting measures related to the affected products as appropriate and urgently as per protocol.

“In Korea, we are identifying sources of affected products and unused products following regulatory reports, and we will expeditiously implement the necessary actions and finalize the related actions in September."