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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0075-2022
Event ID88651
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
DistributionWorldwide distribution - US Nationwide distribution.
Quantity3969 total (US), 3550 total (OUS)
Recall ReasonThe Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.
Device Classification20211013
Device Code InfoAll lots
Center Classification Date20211007
Recall Initiation Date20210908
Recalling FirmDatascope Corp.
Initial Notification Letter
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