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ARROW INTERNATIONAL Inc. Recall 91021

Description: Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump

ARROW INTERNATIONAL Inc. Recall 91021 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0438-2023
Event ID91021
Event DescriptionArrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump
Product TypeDevices
DistributionWorldwide
QuantityN/A
Recall ReasonThere is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Device Classification20221221
Device Code InfoUDI/DI (01) 0 0801902 08496 5, (01) 0 0801902 08496 6, All Lot/Serial Numbers
Center Classification Date20221215
Recall Initiation Date20221017
Recalling FirmARROW INTERNATIONAL Inc.
Initial Notification Letter
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