Device recall
Z-1385-2018: Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic…
FDA device recall · Class II · Datascope Corporation
Key facts
| Recall number (Z-number) | Z-1385-2018 |
|---|---|
| Recall event | 79646 |
| Product | Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the… |
| Product code | DSP |
| Recalling firm | Datascope Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 18, 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