Device recall
Z-0116-2017: Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40…
FDA device recall · Class I · St Jude Medical Inc.
Key facts
| Recall number (Z-number) | Z-0116-2017 |
|---|---|
| Recall event | 75393 |
| Product | Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, CD3249-40Q. Unify Assura, Model No. CD3257-40, CD3357-40C, CD3357-40Q. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular… |
| Product code | LWS |
| Recalling firm | St Jude Medical Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 27, 2018 |
| PMA numbers | P030054, P030054S141 |
| 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