Device recall
Z-2414-2011: Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i…
FDA device recall · Class I · Maquet Datascope Corp - Cardiac Assist Division
Key facts
| Recall number (Z-number) | Z-2414-2011 |
|---|---|
| Recall event | 58661 |
| Product | Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aortic Balloon Pump; CS300 Intra-Aortic Balloon Pump; Manufactured by Datascope Corp., 1300 MacArthur Blvd., Mahwah, NJ 07430 The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and… |
| Product code | FMZ |
| Recalling firm | Maquet Datascope Corp - Cardiac Assist Division |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 25, 2012 |
| 510(k) numbers | K031636 |
| FEI number | 3001418283 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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