Device recall
Z-1928-2018: CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX…
FDA device recall · Class I · Maquet Datascope Corp - Cardiac Assist Division
Key facts
| Recall number (Z-number) | Z-1928-2018 |
|---|---|
| Recall event | 80003 |
| Product | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179 |
| Product code | DSP |
| Recalling firm | Maquet Datascope Corp - Cardiac Assist Division |
| Recall class | Class I |
| Status | Open, Classified |
| 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