During the week of October 21, 2013 Medtronic began notifying its distributors, hospitals and other interested parties that there were potential problems with the coating on some lots of some types of Medtronic guidewires. Medtronic voluntarily requested that these specific guidewires be recalled and sent back to the company. In total, approximately 15,000 Medtronic guidewires were recalled from eight product lines.
The FDA has since classified Medtronic’s voluntary recall of these specific guidewires as an FDA Class I recall. Currently, there are five FDA safety alert classifications, the most serious of which is an FDA Class I recall. According to the FDA, a Class I recall is issued when there is “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” Less serious issues may be classified by the FDA as a Class II recall, a Class III recall, a market withdrawal or a medical device safety alert.
The fact that the FDA classified this particular recall as a Class I recall is important and informs the public of the potentially serious consequences that a defective guidewire may have for a patient.
If you have been hurt, or a loved one has been killed, by a defective Medtronic guidewire then we encourage you to find out more about your legal rights by calling an experienced Louisville Medtronic injury lawyer today at 502-210-8942 or 888-450-4456.