Device recall
Z-0311-2025: MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00…
FDA device recall · Class II · Datascope Corp.
Key facts
| Recall number (Z-number) | Z-0311-2025 |
|---|---|
| Recall event | 95396 |
| Product | MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01 |
| Product code | DSP |
| Recalling firm | Datascope Corp. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K041281, K112327, 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