FDA Recall for St. Jude Medical's Amplatzer TorqVue FX

 Posted on February 20,2013 in Defective Medical Devices

According to a recent article published by www.massdevice.com, St. Jude's has recalled their Amplatzer TorqVue FX delivery system because of concerns about fractures in the core wire.

The FDA has issued the highest-risk label on the recall of the delivery system produced by St. Jude Medical.

St. Jude recalled one component of the delivery system because a certain part may fracture, which could cause adverse consequences or even death, according to an FDA report.

The purpose of the Amplatzer device is to treat a condition called patent foramen ovale, in which a naturally occurring hole in the heart fails to close after birth. This open hole has the potential to allow blood clots to travel from one side of the heart to the other and then to the brain, which could cause a stroke.

An “Urgent Medical Device Recall Notice” was sent to St. Jude's costumers last month in order to notify them of the issues, according to the FDA notice.

The FDA notice stated, “The letter advised customers to stop using the device and remove it from their inventory. St. Jude Medical plans to have their sales representatives perform site visits to assist with recall activities, including completion of the product reconciliation form and return of any unused product.”

The recall was given the Class 1 status by the FDA, which is usually reserved for “the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”

When devices such as the Amplatzer are used, there is no room for error. If you have been injured by a medical device, you may be entitled to medical compensation for medical bills, lost wages, pain and suffering, and other damages. Be sure to contact a dedicated Illinois Defective Medical Device attorney immediately.