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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0336-2022
Event ID88983
Event DescriptionCardiosave 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 TypeDevices
DistributionWorldwide distribution - US Nationwide.
Quantity4,338 (US); 3,613 (OUS)
Recall ReasonFirm 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 Classification20211222
Device Code InfoAll Unit Serial Numbers
Center Classification Date20211215
Recall Initiation Date20211115
Recalling FirmDatascope Corp.
Initial Notification Letter
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