Food and Drug Administration issues Class I medical device recall

On Behalf of | Jul 25, 2020 | Pharmaceutical Litigation

Every day, across the country and here in Ohio, patients rely on medical devices to stay alive, to receive a diagnosis and more. They rely on these devices to work properly and function as intended, but that does not always happen. Far too often, the Food and Drug Administration oversees recalls due to flaws and defects that could cause serious injury or death.

Recently, the agency issued a Class I recall after Verathon, Inc. recalled its GlideScope Core One™ TouchSmart Cable. This type of recall means that use of the device could cause patients to suffer serious or fatal injuries. The cable is part of a system used during medical procedures to view a patient’s vocal cords and airway.

The problem is that it could fail during a procedure. The doctor using it loses his or her view, which could cause a serious or fatal error. The patient undergoing the procedure could suffer from oxygen deprivation, which could lead to death along with a host of other adverse medical issues, such as brain damage. So far, the company has received 74 complaints regarding the device, and the FDA has been given nine medical device reports so far.

Due to the seriousness of this device failure, Verathon and the Food and Drug Administration recommend that medical professionals immediately stop using the device until they receive a replacement. In the meantime, the possibility of someone suffering harm due to it still exists. If anyone here in Ohio falls into that category due to this or some other defective medical device, it may be possible to pursue restitution for the harm done.

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