Drug recall
Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan
FDA recall event 76853 · Class II · Medtronic Inc., Cardiac Rhythm and Heart Failure
Key facts
| Event ID | 76853 |
|---|---|
| Recall numbers | Z-2117-2017 |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Product type | Devices |
| Products | Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Apr 12, 2017 |
| Report date | May 31, 2017 |
| Termination date | Jul 16, 2019 |
| City | Mounds View |
| State | MN |
| Country | United States |
| FEI number | 2182208 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: