Device recall
Z-1386-2017: CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is…
FDA device recall · Class II · Maquet Datascope Corp - Cardiac Assist Division
Key facts
| Recall number (Z-number) | Z-1386-2017 |
|---|---|
| Recall event | 76052 |
| Product | CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons |
| Product code | DSP |
| Recalling firm | Maquet Datascope Corp - Cardiac Assist Division |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 1, 2019 |
| 510(k) numbers | K112372, K151254 |
| 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