Medtronic, Inc. recalls Dual Chamber Implantable Pulse Generators (IPGs) due to possible circuit error
Medtronic is recalling its dual chamber IPGs due to the possibility of a software error that can result in a lack of pacing. Patients and physicians cannot predict whether and when this software error might occur. A lack of pacing could result in patients experiencing slow heart beating, low blood pressure, and symptoms such as light headedness, fainting, and even death.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. The recalled products include Medtronic, Inc. Dual Chamber Implantable Pulse Generators (IPGs) with model names: Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron A, E, G, Q series. They were manufactured between March 2, 2017, to December 18, 2018. The total number of devices recalled in the U.S. is 13,440.
Medtronic’s Dual Chamber Implantable Pulse Generators (IPGs) are implanted cardiac pacemakers used to provide stimulation to increase heart rate in patients with a slow heart rhythm (bradycardia) or no heart rhythm. The pulse generator is the small implanted unit containing the battery and other electronic parts. The pulse generator must be used with insulated electrode wires called leads. These devices are designed to be used in addition to routine clinical monitoring by a health care professional.
