FDAApril 12, 2017device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

medtronic inc cardiac rhythm and heart failuremedtronicmedtronic inc

UPCs

00643169543362

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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