Drug recall
Medtronic, Evera Implantable Cardioverter Defibrillators: Product Model EVERA XT DDBB1D1, DDBB1D4, DDBB2D1…
FDA recall event 74923 · Class II · Medtronic Inc., Cardiac Rhythm and Heart Failure
Key facts
| Event ID | 74923 |
|---|---|
| Recall numbers | Z-2650-2016, Z-2651-2016 |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure |
| Product type | Devices |
| Products | Medtronic, Evera Implantable Cardioverter Defibrillators: Product Model EVERA XT DDBB1D1, DDBB1D4, DDBB2D1, DDBB2D4, DVBB2D4, DVBB1D1. EVERA S DDBC3D1, DDBC3D4 Product Usage: The Medtronic Evera DR…, Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1, DTBA1D4 VIVASCRT-D DTBB1D1, DTBB1D4 Product Usage: The Medtronic Viva CRT -D dual chamber… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low resistance path developing within the circuit… |
| Initiation date | Aug 12, 2016 |
| Report date | Aug 31, 2016 |
| Termination date | Jan 20, 2017 |
| 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: