Reported May 31, 2017 · Terminated
Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan
Medtronic Inc., Cardiac Rhythm and Heart Failure
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Inc., Cardiac Rhythm and Heart Failure · 8200 Coral Sea St NE · Mounds View, MN · 55112-4391
Is this the product you have?
- Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan
- Lot codes and dates
- UPN Lot Serial #
2,414 of 2,414 codes
00643169543362RPA200003H00643169543362RPA200004H00643169543362RPA200005H00643169543362RPA200006H00643169543362RPA200007H00643169543362RPA200008H00643169543362RPA200009H00643169543362RPA200010H00643169543362RPA200011H00643169543362RPA200012H00643169543362RPA200013H00643169543362RPA200014H00643169543362RPA200015H00643169543362RPA200016H00643169543362RPA200017H00643169543362RPA200018H00643169543362RPA200019H00643169543362RPA200021H00643169543362RPA200022H00643169543362RPA200023H00643169543362RPA200024H00643169543362RPA200025H00643169543362RPA200026H00643169543362RPA200027H00643169543362RPA200028H00643169543362RPA200029H00643169543362RPA200030H00643169543362RPA200031H00643169543362RPA200032H00643169543362RPA200033H
- UPN Lot Serial #
- Amount recalled
- 25,025 ( 16,369 US; 8,656 OUS)
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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