Drug recall
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use.
FDA recall event 82897 · Class I · Datascope Corp.
Key facts
| Event ID | 82897 |
|---|---|
| Recall numbers | Z-1939-2019, Z-1940-2019, Z-1941-2019, Z-1942-2019, Z-1943-2019, Z-1944-2019 |
| Recalling firm | Datascope Corp. |
| Product type | Devices |
| Products | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use., Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For cardiovascular use., CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiovascular use., CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiovascular use., CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiovascular use. and 1 more |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Battery short-run times and unanticipated stoppage may be due to user not performing battery maintenance and handling as needed. Inadequate labeling is being targeted for this recall, and design…, If battery maintenance is not performed appropriately, the battery may provide less than the minimum run time of operating power. Revised labeling and training are being offered., If battery maintenance… |
| Initiation date | Jun 17, 2019 |
| Report date | Jul 24, 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: