Device recall
Z-2221-2023: SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to…
FDA device recall · Class II · Datascope Corp.
Key facts
| Recall number (Z-number) | Z-2221-2023 |
|---|---|
| Recall event | 92527 |
| Product | SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Number SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES D684-00-0568-01 SENSATION PLUS 7.5Fr. 40cc WITH ACCESSORIES (W/O STATLOCK) D684-00-0568-03… |
| Product code | DSP |
| Recalling firm | Datascope Corp. |
| Recall class | Class II |
| Status | Open, Classified |
| 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