Device recall
Z-0595-2024: CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide…
FDA device recall · Class III · Maquet Medical Systems USA
Key facts
| Recall number (Z-number) | Z-0595-2024 |
|---|---|
| Recall event | 93462 |
| Product | CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product REF Numbers: 701072780… |
| Product code | DTQ |
| Recalling firm | Maquet Medical Systems USA |
| Recall class | Class III |
| 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