Device recall
Z-2164-2017: SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit &…
FDA device recall · Class II · Datascope Corporation
Key facts
| Recall number (Z-number) | Z-2164-2017 |
|---|---|
| Recall event | 76942 |
| Product | SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK Product Code/Part Number: 0684-00-0576-01U is a cardiac assist device which support the heart's left ventricle by increasing coronary perfusion and reducing the work of the left ventricle. |
| Product code | DSP |
| Recalling firm | Datascope Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 28, 2020 |
| 510(k) numbers | K133074 |
| FEI number | 1000222374 |
At a glance
- 1–9 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