Device recall
Z-1506-2021: Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic…
FDA device recall · Class III · Datascope Corp.
Key facts
| Recall number (Z-number) | Z-1506-2021 |
|---|---|
| Recall event | 87482 |
| Product | Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52… |
| Product code | DSP |
| Recalling firm | Datascope Corp. |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K112372, K151254, K163542 |
| FEI number | 3001418283 |
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