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FDA warns of serious defects in Medtronic devices

Virginia readers may be interested in a Food and Drug Administration (FDA) warning issued for some Medtronic devices, and the defects are serious enough that they might cause severe injury or death for patients. The warning was issued for approximately 15,000 guidewires, which have been recalled by Medtronic.

According to a company spokesman, Medtronic received reports of four complaints regarding the guidewires. One of the complaints included a patient who went into cardiac arrest but was then later successfully resuscitated. Medtronic began a recall of the defective product on Oct. 21.

The guidewires are coated to facilitate movement through blood vessels. According to the recall notice issued by Medtronic, the coating on the guidewires might break away, which might cause a blockage in a blood vessel. The company reported that the recall was for lots that have been manufactured since April. In addition to the recall, Medtronic has taken steps to prevent any new shipments of the defective wires. On Nov. 15, Medtronic announced that the FDA had given the recall a Class I designation, a category that is reserved for products that have potential to cause either serious injury or death for patients.

Companies that manufacture dangerous or defective products may be held liable to pay compensation to affected patients and their families. An individual or family might not have the resources to bring a successful lawsuit against a large medical device manufacturer. A class action lawsuit can be a vehicle for many people to join forces to take on a large company. A personal injury attorney might be able to assist a family seeking to file an independent claim or join a class action lawsuit.

Source: USA Today, "FDA issues stern warning on Medtronic devices", David Koenig, November 16, 2013

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