Medtronic, in conjunction with the FDA, has issued Class I recall – the most serious type of recall classification reserved for products whose continued use could lead to serious illness or death – of the following lines of pacemakers:
· Medtronic Kappa Series 600/700/900
· Medtronic Sigma Series 100/200/300
The recall has been issued because of a serious risk of operational failure. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. Pacemaker-dependent patients may experience serious injury or even death. Most of the pacemakers affected by this recall have been implanted in patients for five years or longer.
Alley, Clark & Greiwe has been involved with Medtronic litigation for years, and our attorneys have been directly involved with other Medtronic recalls (including Medtronic Sprint Fidelis Leads and Medtronic Implantable Cardioverter Defibrillators (ICD) devices). While it’s unfortunate that another model line has been recalled, it is not particularly surprising. Please contact our office and we will help you determine if a particular pacemaker is part of this recall.