The FDA has designated Medtronic’s product recall of implanted cardiac pacemakers as a class 1 recall, the most serious kind. The recall affects 13,440 devices manufactured and distributed between March 2, 2017, and Jan. 7, 2019.
Possible circuit errors in the devices, used in patients with bradycardia or no heart rhythm to increase their heart rate, may lead to a lack of pacing and result in patients with low BP, slow heart beats and symptoms such as fainting, lightheadedness and death, according to a MedWatch report from the FDA.
The recall affects several devices by Medtronic, including Versa, Adapta, Relia, Sensia, Sphera, Attesta and Vitatron A, E, G and Q series.
Medtronic distributed a notice to implanting and follow-up physicians starting Jan. 17 alerting them to program the device to a nonsusceptible pacing mode until a software update has been installed, according to the report. Physicians are also recommended to perform additional patient risk assessments and programming recommendations. Those treating patients with affected devices are advised to return unopened and unused devices to Medtronic. Patients are also instructed to seek immediate medical attention if they are experiencing any symptoms potentially related to a pause in pacing, according to the report.