Device recall
Z-1966-2019: Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part…
FDA device recall · Class II · Datascope Corporation
Key facts
| Recall number (Z-number) | Z-1966-2019 |
|---|---|
| Recall event | 83022 |
| Product | Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories is a device that includes a catheter, an insertion kit and two STATLOCK IAB stabilization devices. It is… |
| Product code | DSP |
| Recalling firm | Datascope Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 25, 2023 |
| 510(k) numbers | K122628 |
| 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