FDA Device recall Z-2117-2017
Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan
- FDA Device
- Class II
- terminated
- Published 2017-05-31
On 2017-05-31 the FDA classified a Class II recall of Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan by Medtronic Cardiac Rhythm And Heart Failure, citing an unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia' "', Claria'"', and Compia'"' Quad CRT-D MRI devices.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2117-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-12 |
| Published | 2017-05-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure |
| Distribution | US |
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.
Identifiers
| code_info | UPN Lot Serial # 00643169543362 RPA200003H 00643169543362 RPA200004H 00643169543362 RPA200005H 00643169543362 RPA20…UPN Lot Serial # 00643169543362 RPA200003H 00643169543362 RPA200004H 00643169543362 RPA200005H 00643169543362 RPA200006H 00643169543362 RPA200007H 00643169543362 RPA200008H 00643169543362 RPA200009H 00643169543362 RPA200010H 00643169543362 RPA200011H 00643169543362 RPA200012H 00643169543362 RPA200013H 00643169543362 RPA200014H 00643169543362 RPA200015H 00643169543362 RPA200016H 00643169543362 RPA200017H 00643169543362 RPA200018H 00643169543362 RPA200019H 00643169543362 RPA200021H 00643169543362 RPA200022H 00643169543362 RPA200023H 00643169543362 RPA200024H 00643169543362 RPA200025H 00643169543362 RPA200026H 00643169543362 RPA200027H 00643169543362 RPA200028H 00643169543362 RPA200029H 00643169543362 RPA200030H 00643169543362 RPA200031H 00643169543362 RPA200032H 00643169543362 RPA200033H 00643169543362 RPA200034H 00643169543362 RPA200035H 00643169543362 RPA200036H 00643169543362 RPA200037H 00643169543362 RPA200038H 00643169543362 RPA200039H 0064316954 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2117-2017%22
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