Recall Z-2117-2017— Medtronic Inc., Cardiac Rhythm and Heart Failure

Name: FDA recall Z-2117-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-12

Class II · Terminated

Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure, initiated 2017-04-12, terminated 2019-07-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan. Reason: An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia' "', Claria'"', and Compia'"' Quad CRT-D MRI devices..

Recalling firm: Medtronic Inc., Cardiac Rhythm and Heart Failure
Classification: Class II
Status: Terminated
Initiated: 2017-04-12
Terminated: 2019-07-16
Firm location: Mounds View, MN, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.