Device recall
Z-1389-2020: LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product…
FDA device recall · Class III · LivaNova USA Inc.
Key facts
| Recall number (Z-number) | Z-1389-2020 |
|---|---|
| Recall event | 84732 |
| Product | LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood. |
| Product code | DWE |
| Recalling firm | LivaNova USA Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 9, 2021 |
| 510(k) numbers | K981613 |
| FEI number | 1718850 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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