Device recall
Z-1147-2023: Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33…
FDA device recall · Class I · Datascope Corp.
Key facts
| Recall number (Z-number) | Z-1147-2023 |
|---|---|
| Recall event | 91603 |
| Product | Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-33* 0998-UC-0800-52* 0998-UC-0800-53* 0998-00-0800-55* * -- not distributed in US |
| Product code | DSP |
| Recalling firm | Datascope Corp. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K181122 |
| 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