Datascope Corp. Recall 88983
Description: Cardiosave Hybrid Model UDI 0998-00-0800-31 10607567109053 0998-00-0800-32 10607567111117 0998-00-0800-33 10607567109008 0998-00-0800-34 10607567111940 0998-00-0800-35 10607567109107 0998-00-0800-45 10607567108421 0998-00-0800-52 10607567108438 0998-00-0800-53 10607567108391 0998-00-0800-55 10607567108414 0998-00-0800-65 10607567113432
Datascope Corp. Recall 88983 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0336-2022 |
| Event ID | 88983 |
| Event Description | Cardiosave Hybrid Model UDI 0998-00-0800-31 10607567109053 0998-00-0800-32 10607567111117 0998-00-0800-33 10607567109008 0998-00-0800-34 10607567111940 0998-00-0800-35 10607567109107 0998-00-0800-45 10607567108421 0998-00-0800-52 10607567108438 0998-00-0800-53 10607567108391 0998-00-0800-55 10607567108414 0998-00-0800-65 10607567113432 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide. |
| Quantity | 4,338 (US); 3,613 (OUS) |
| Recall Reason | Firm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components thus leading to system shutdown, which could result in unsafe hemodynamic instability. |
| Device Classification | 20211222 |
| Device Code Info | All Unit Serial Numbers |
| Center Classification Date | 20211215 |
| Recall Initiation Date | 20211115 |
| Recalling Firm | Datascope Corp. |
| Initial Notification | Letter |
| Similar To |