The Fridley, Minn.-based company issued a recall in January on pacemakers with model names Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron due to a software error that can result in a lack of pacing.
Patients and physicians cannot predict whether and when this software error might occur, according to FDA, which gave the recall a Class I designation, the most serious type of recall. 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 company said two patient experienced a pause in pacemaking, but that no deaths were reported.
Medtronic said the root cause for the issue is related to a design change to an integrated circuit in a subset of devices that were distributed between March 10, 2017, and January 7, 2019. The recall includes 13,440 devices distributed in the U.S.
Medtronic said it is developing a software update that can be installed into affected devices to correct the issue. Meanwhile, the company has asked that physicians return all unused and unopened devices affected by the recall. The company also warned patients to seek immediate medical attention if experiencing any new or unexpected symptoms consistent with a pause in pacing.