Device recall
Z-0091-2022: Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the…
FDA device recall · Class I · Datascope Corp.
Key facts
| Recall number (Z-number) | Z-0091-2022 |
|---|---|
| Recall event | 88719 |
| Product | Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numbers. 1. Cardiosave Hybrid. Model Numbers: 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45… |
| Product code | DSP |
| Recalling firm | Datascope Corp. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K112372, K151254, K163542, 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