Device recall
Z-0457-2012: St. Jude Medical Riata (8Fr), Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580…
FDA device recall · Class I · St Jude Medical CRMD
Key facts
| Recall number (Z-number) | Z-0457-2012 |
|---|---|
| Recall event | 60571 |
| Product | St. Jude Medical Riata (8Fr), Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592 Product Usage: These Silicone transvenous high voltage (HV) leads connect an implantable cardioverter-defibrillator (lCD or CRT-D) to cardiac tissue to monitor and regulate a patients heart… |
| Product code | LWS |
| Recalling firm | St Jude Medical CRMD |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 9, 2012 |
| PMA numbers | P950022 |
| 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