Medtronic Recalls Dual Chamber Implantable Pulse Generators
16 February 2019 - 7:05AM
Dow Jones News
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 michael.dabaie@wsj.com
(END) Dow Jones Newswires
February 15, 2019 14:50 ET (19:50 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
Medtronic (NYSE:MDT)
Historical Stock Chart
From Mar 2024 to Apr 2024
Medtronic (NYSE:MDT)
Historical Stock Chart
From Apr 2023 to Apr 2024