Medtronic Issues a Class 1 Recall On All MICRA

Pacemakers Across The Globe

Company is taking prompt action to ensure the safety of customers.

DUBLIN, IRELAND, March 16, 2020 – Medtronic has issued a class 1 recall on the MICRA

pacemakers distributed between October 2018 and December 2019. A programming flaw that

causes the device to not regulate a patient’s heartbeat properly was detected. Despite the small

number of sensor microchips with the faulty programming, a class 1 recall was decided upon due

to the reasonable probability that the use of the product could cause serious health consequences

to the individual. Approximately 6% of sensor microchips in the MICRA AV (Model number:

MC1AVR1) and MICRA VR (Model number: MC1VR01) pacemakers have been recognized as

faulty.

Medtronic has taken prompt measures to ensure the safety of their customers and have begun

conducting quality control testing on all MICRA pacemakers manufactured and distributed in

January 2020 and later. Further testing will be also be done on all other Medtronic pacemakers

with the same or similar sensor chips manufactured and distributed during the same time

window. As one of the largest medical device companies in the world, Medtronic’s first priority

is to contribute to human welfare, and they are thankful for the continued support.

If you or anyone you know has a Medtronic MICRA pacemaker and has experienced symptoms

such as cardiac arrhythmia, chest pain, shortness of breath, or erratic blood pressure, please seek

immediate medical attention. Affected individuals are also advised to contact their doctor or
cardiac surgeon. For more information, please call the Medtronic customer recall hotline at

1-800-555-6978.

Contact:
Medtronic Operational Headquarters
Toll Free: 800-633-8766
Worldwide: +1 763 514 4000

Kara Nowakowski, Communications Representative

419-777-8888
nowakokm@miamioh.edu

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