Datascope Corp. Recall 88651
Description: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65
Datascope Corp. Recall 88651 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0075-2022 |
Event ID | 88651 |
Event Description | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65 |
Product Type | Devices |
Distribution | Worldwide distribution - US Nationwide distribution. |
Quantity | 3969 total (US), 3550 total (OUS) |
Recall Reason | The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference. |
Device Classification | 20211013 |
Device Code Info | All lots |
Center Classification Date | 20211007 |
Recall Initiation Date | 20210908 |
Recalling Firm | Datascope Corp. |
Initial Notification | Letter |
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