Class I Recall for Certain Medtronic Pacemakers Due to Possible Circuit Error
According to an FDA recall notice, issued today, the action affects 13,440 devices in the United States.
Medtronic has recalled certain models of its dual-chamber implantable pulse generators because of the possibility of a software error that can cause a lack of pacing, the US Food and Drug Administration announced Friday.
The action—which the FDA has deemed a class I recall, the most serious type—affects the following pacemaker models: Adapta, Versa, Sensia, Relia, Attesta, Sphera, and the Vitatron A, E, G, and Q series. More than 13,000 devices distributed in the United States between March 6, 2017, and January 7, 2019, are affected.
Medtronic said in an advisory that as of January 4 it was aware of four reported incidents involving two patients that could be tied to this issue. There were no deaths.
Medtronic began notifying physicians of the issue on January 17 by delivering “Field Corrective Action Notification” letters. The company is developing a software update to fix the problem, which it expects to submit to regulatory authorities by the second half of the year. Medtronic recommends that physicians program affected pacemakers to a nonsusceptible pacing mode until the update can be installed; further instructions can be found in the advisory.
Any unused or unopened products should be returned to the company for a replacement.
US Food and Drug Administration. Medtronic, Inc. recalls dual chamber implantable pulse generators (IPGs) due to possible circuit error. Published on: February 15, 2019. Accessed on: February 15, 2019.