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Datascope Corp. Recall 88664

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 88664 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2615-2021
Event ID88664
Event DescriptionCardiosave 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 TypeDevices
DistributionNationwide domestic distribution. Foreign distribution worldwide.
Quantity3969 total (US), 3550 total (OUS)
Recall ReasonThe Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.
Device Classification20211006
Device Code InfoAll lots
Center Classification Date20210930
Recall Initiation Date20210908
Recalling FirmDatascope Corp.
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