FDA Issues Recall of Medtronic Devices

 Posted on December 18, 2013 in FDA

The U.S. Food and Drug Administration (FDA) has issued a Class I recall of approximately 15,000 Medtronic devices used during heart procedures due to a risk of serious injury or death. The recall affects Medtronic Interventional Guidewires and ATTAIN HYBRID Guidewires. According to the FDA, these are the long, thin wires that are inserted through the artery in order to guide the placement of diagnostics or medical devices such as stents. It has been found that the polytetrafluoroethylene coating (more commonly known as Teflon) that helps the wires slide more easily through the artery can detach have the potential to block a blood vessel.

The recall effects lots of the Medtronic guidewires manufactured from April of 2013 onwards. The FDA ordered the recall in October after four serious problems were reported, including one that involved a patient who suffered cardiac arrest, but was resuscitated. The company has contacted regulators worldwide and halted any new shipments of the wires.

A Class I recall is the most serious type of recall that can be issued, and is only used in situations where use of a medical device or medication may cause serious consequences to a patient's health, or result in death. Anyone with questions regarding this recall is encouraged to visit the FDA website, or to contact the Medtronic Lifeline Technical Support line by calling (877)-526-7890, Monday through Friday from 8am to 5pm.

If you or someone you love has suffered additional injuries due to the use of a Medtronic or any other defective medical device, it is important that you receive advice from a qualified attorney. At Newland & Newland, we have dealt with a number of cases involving defective medical devices, and can advise you on how you might proceed. Contact us today for a free phone consultation so that we can address any questions and concerns you have.