Drug recall
Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q…
FDA recall event 78068 · Class I · St Jude Medical Inc.
Key facts
| Event ID | 78068 |
|---|---|
| Recall numbers | Z-0003-2018, Z-0004-2018 |
| Recalling firm | St Jude Medical Inc. |
| Product type | Devices |
| Products | Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify…, Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The device may exhibit premature battery depletion. |
| Initiation date | Aug 28, 2017 |
| Report date | Oct 18, 2017 |
| Termination date | Jan 20, 2024 |
| City | Sylmar |
| State | CA |
| Country | United States |
| FEI number | 2017865 |
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: