Medical device company Vascular Solutions has recalled a number of its products that are used for catheterization because they could potentially cause serious injury or even death if the devices malfunction, the Twin Cities Business Journal reports.
According to the media outlet, the Maple Grove, Minnesota-based firm recalled both of the valves it has developed for use during catheterization procedures because of the potential safety problems. Vascular’s sister company Vascular Solutions Zerusa, Ltd made the official recall, saying its Guardian II and Guardian II NC hemostasis valves may come with the structural problems. Both products are used to allow doctors to insert several devices into an artery at once, with a special focus on keeping blood loss to a minimum.
Instead, the valves have reportedly been found to “pose a slightly increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death,” according to a statement made by the company. So far, all of the potentially faulty products were found to have been manufactured and sold between February 2012 and February 2013.
According to the media outlet, the company asserted no injuries have been linked to the potential defect.
The U.S. Food and Drug Administration also issued a product alert regarding the devices, calling it a “Class 1” recall, suggesting the product can create a situation “in which there is a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.”
The latest recall isn’t the only one the Guardian series of medical devices has been through. In September 2012, a few batches of the products were hit with “Class II” recalls, which the FDA issues when any product has the potential to cause “temporary or medically reversible adverse health consequences,” or when “the probability of serious adverse health consequences is remote.”
Last year’s recall was reported after the company noted some products did not have the proper seals, which could potentially have led to the contamination of the product. Considering Vascular Solutions has a product base of more than 70 items, and is one of the 70 largest public companies in Minnesota, the recall is not being taken lightly.
Many medical device manufacturers are focusing on the product testing phase, as improvements here can lead to fewer recalls and much lower costs associated with solving the issue.