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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
Recalled May 31, 2017 · FDA recall Z-2117-2017 · Medtronic Inc., Cardiac Rhythm and Heart Failure
Hazard
An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia' "', Claria'"', and Compia'"' Quad CRT-D MRI devices. · FDA Class II
Units
25,025 ( 16,369 US; 8,656 OUS)
Sold at
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 Portugal Cyprus Hungary Luxembourg Denmark India Macedonia Reunion Dominican Republic Iran Malaysia Singapore
Description
An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia' "', Claria'"', and Compia'"' Quad CRT-D MRI devices.
Product
Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan
Manufacturer(s)
Medtronic Inc., Cardiac Rhythm and Heart Failure
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →