Medtronic Inc., Cardiac Rhythm and Heart Failure recalls Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan

Recall date

April 12, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2117-2017

FDA classification

Class II

Brand / firm

Medtronic Inc., Cardiac Rhythm and Heart Failure

Sold / distributed

USA: Nationwide including DC & PR. Worldwide- Distribution : Australia Egypt Ireland Morocco Austria Finland Israel Netherlands Bangladesh France Italy New Zealand Belgium Germany Japan Norway Brunei Darussalam Greece Jordan Oman Canada Guadeloupe Kuwait Poland Cayman Islands Hong Kong Lebanon Port…

Why it was recalled

An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia' "', Claria'"', and Compia'"' Quad CRT-D MRI devices.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan