The U.S. Food and Drug Administration (FDA) recently released a warning that defects in certain Medtronic devices used in heart surgical procedures are dangerous and may cause serious injury or death. The warning issued to hospitals and distributors worldwide says that the coating on the guidewires may break off and could increase the chance of blocking a blood vessel.
Recalling the dangerous devices
A recall of the guidewires began a month before when Medtronic received reports of four complaints. One patient went into cardiac arrest when the Medtronic device malfunctioned.
The recall covers guidewires that are designed to aid percutaneous coronary interventions or the placement of left ventricular leads for cardiac rhythm devices. The following product lines that were manufactured after mid-April 2013 are included in the recall:
Cougar nitinol workhorse guidewire
Cougar steerable guidewire
Zinger stainless steel workhorse guidewire
Zinger steerable guidewire
Thunder extra-support guidewire
Thunder steerable guidewire
ProVia crossing guidewire
Attain Hybrid guidewire
Healthcare service professionals and patients are strongly encouraged to inform the FDA of any other adverse events to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
This is not the first time
A few weeks before the FDA issued its warning concerning Medtronic's guidewires, the FDA released a report giving a less than positive appraisal of Medtronic’s Cardiac Ablation System. Atrial fibrillation is the most prevalent heart rhythm disorder affecting more than two million Americans. Medtronic's Cardiac Ablation System has been found to be effective for treating atrial fibrillation, but the FDA review staff expressed concerns about the high rate of stroke that occurred in patients treated by the device. In a clinical trial, 5 out of 176 people had a stroke within a month of using the device.
Did you or a loved one suffer injuries from a defective medical device such as Medtronic’s heart devices?