Device recall
Z-1523-2014: Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump…
FDA device recall · Class I · Maquet Datascope Corp - Cardiac Assist Division
Key facts
| Recall number (Z-number) | Z-1523-2014 |
|---|---|
| Recall event | 67815 |
| Product | Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures. |
| Product code | DSP |
| Recalling firm | Maquet Datascope Corp - Cardiac Assist Division |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 20, 2018 |
| 510(k) numbers | K031636 |
| 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