Drug recall
CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery…
FDA recall event 76052 · Class II · Maquet Datascope Corp - Cardiac Assist Division
Key facts
| Event ID | 76052 |
|---|---|
| Recall numbers | Z-1386-2017 |
| Recalling firm | Maquet Datascope Corp - Cardiac Assist Division |
| Product type | Devices |
| Products | CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally… |
| Initiation date | Dec 23, 2016 |
| Report date | Mar 8, 2017 |
| Termination date | Mar 1, 2019 |
| City | Mahwah |
| State | NJ |
| Country | United States |
| FEI number | 3001418283 |
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: