Device recall
Z-0003-2018: Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model…
FDA device recall · Class I · St Jude Medical Inc.
Key facts
| Recall number (Z-number) | Z-0003-2018 |
|---|---|
| Recall event | 78068 |
| Product | 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 Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model… |
| Product code | LWS |
| Recalling firm | St Jude Medical Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jan 20, 2024 |
| PMA numbers | P910023, P910023S386 |
| FEI number | 2017865 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database