FDA Issues Warning About Medtronic Guidewire Recall

According to the Wall Street Journal, the U.S. Food and Drug Administration (FDA) has issued a warning in regards to recalled medical devices made by Medtronic Inc., which have been linked to injuries.

The FDA issued a warning in November with regards to a recall initiated by Medtronic of nearly 15,000 guidewires that are used in heart procedures. The recall is a Class I recall, the most serious classification given to product recalls.

Medtronic said in October that the coating on the guidewires had the potential to detach and delaminate, which could lead to blood clots or damage to vital organs. Further, the recalled devices may have the potential to cause strokes and heart attacks.

The company reportedly received four complaints about the product, including a report about a patient who suffered cardiac arrest. Medtronic said that 14,896 guidewires from 181 lots are being recalled.

The guidewires are thin wires inserted through blood vessels to help guide other medical devices into place within the body, such as devices used to open blocked arteries or the leads used to connect the heart to an implanted pacemaker.

According to the FDA, “health-care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.”

For more information, contact our experienced pharmaceutical drug and device attorneys by calling toll-free (888)-841-9623. today.

Source: http://online.wsj.com/news/articles/SB10001424052702303789604579202070968854270