iPulse Circulatory Support System Catalog number: 0036-0010 The iPulse System Console is a multi-purpose mechanical circulatory support system used to support patients suffering from acute cardiovascular failure. The iPulse console can be used to drive exclusively one of two classes of therapeutic devices: either pneumatically actuated Ventricular Assist Devices (VADs) for total circulatory support, or (i.e., non-simultaneously) an intra-aortic balloon (IAB) catheter for counter-pulsation therapy.
FDA Recall Z-1931-2009 · Posted 2009-09-16
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Recalling FirmAbiomed, Inc.
Recall StatusTerminated
Product CodeDSQ
Date Initiated2009-04-23
Date Terminated2014-06-05
Product Quantity79
Reason for Recall
iPulse Console SC1035 displayed a "Low Pressure / Low Flow" alarm and stopped pumping during patient transport in battery operation.
Firm Action
An "Urgent Voluntary Medical Device Field Correction Notice" was issued April 8, 2009 to affected customers. The customers were notified that the iPulse Console SC1032 displayed a "Low Pressure/ Low Flow" alarm and stopped pumping during patient transport in battery operation. Instructions were provided to users in case they encounter this failure mode. ABIOMED Field Service Engineers will contact customers to schedule a time to visit site and correct affected consoles. Please contact ABIOMED's Field Service at 1.800.554.8666, if you have any questions.
Root Cause
Device Design
Distribution Pattern
Domestic: MA, MI, SC, NY, NJ, OH, CA, PA, AR, MI, MD, CT, IL, WI, TX, NJ, TN, IN, MI, DE, FL, IA, WA, KY, and WV Foreign: Germany, Greece, Italy, Latvia, Spain, and Turkey
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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