February 19, 2019
FDA: Class I recall of Medtronic’s Dual Chamber Implantable Pulse Generators
Editor's Note
The Food & Drug Administration (FDA) on February 15 identified Medtronic, Inc’s (Dublin, Ireland) recall of it’s Dual Chamber Implantable Pulse Generators (IPGs) as Class I, the most serious.
The recall was initiated because of the possibility of a software error that can result in a lack of pacing. A lack of pacing could result in patients experiencing slow heart beating, low blood pressure, light headedness, fainting, and death.
Distribution dates for the IPGs were March 6, 2017 to January 7, 2019.
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