Drug recall
CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood…
FDA recall event 93462 · Class III · Maquet Medical Systems USA
Key facts
| Event ID | 93462 |
|---|---|
| Recall numbers | Z-0595-2024 |
| Recalling firm | Maquet Medical Systems USA |
| Product type | Devices |
| Products | 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… |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CARDIOHELP-i System was not properly tested to measure leakage current |
| Initiation date | Nov 14, 2023 |
| Report date | Dec 27, 2023 |
| City | Wayne |
| State | NJ |
| Country | United States |
| FEI number | 3008355164 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: