Medtronic Recalls Dual Chamber Implantable Pulse Generators

By Michael Dabaie

Medtronic (MDT) is recalling more than 13,000 dual chamber implantable pulse generators due to a possible circuit error, a posting on the Food and Drug Administration web site said Friday.

The FDA identified it as a Class I recall, the most serious type, indicating use of these devices may cause serious injuries or death, the recall notice said.

Medtronic's dual chamber implantable pulse generators are implanted cardiac pacemakers providing stimulation to increase heart rate in patients with a slow heart rhythm or no heart rhythm. The pulse generator is the small implanted unit containing the battery and other electronic parts.

Medtronic is recalling its dual chamber IPGs due to the possibility of a software error that can result in a lack of pacing, the recall notice said. Patients and physicians can't predict if and when this software error might occur.

The devices were made between March 2, 2017, and December 18, 2018 and distributed from March 6, 2017, to January 7, 2019. The model names Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron A, E, G, Q series.

Medtronic shares were up about 1% Friday, in line with the market.

Recall notice: https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm631470.htm

Write to Michael Dabaie at [e-mail]

(END) Dow Jones Newswires

February 15, 2019 14:50 ET (19:50 GMT)

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