Drug recall
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31…
FDA recall event 92480 · Class I · Datascope Corp.
Key facts
| Event ID | 92480 |
|---|---|
| Recall numbers | Z-2437-2023, Z-2438-2023 |
| Recalling firm | Datascope Corp. |
| Product type | Devices |
| Products | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35…, Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85 |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Users were identifying autofill failure conditions on the devices causing pump stops. |
| Initiation date | Jul 31, 2023 |
| Report date | Sep 6, 2023 |
| 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: