Device recall
Z-0420-2024: CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP…
FDA device recall · Class I · Maquet Medical Systems USA
Key facts
| Recall number (Z-number) | Z-0420-2024 |
|---|---|
| Recall event | 93197 |
| Product | CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system. |
| Product code | DTQ |
| Recalling firm | Maquet Medical Systems USA |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K133598 |
| FEI number | 3008355164 |
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