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U.S. Department of Health and Human Services

Class 2 Device Recall iPulse Circulatory Support System

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 Class 2 Recall
iPulse Circulatory Support System
see related information
Date Posted September 16, 2009
Recall Status1 Open
Recall Number Z-1931-2009
Recall Event ID 52200
Premarket Approval
PMA Number
P900023
Product Classification Ventricular (Assisst) Bypass - Product Code DSQ
Product 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.
Code Information Serial numbers: SC1000, SC1001, SC1003 - SC1010, SC1014 - SC1023, SC1025 - SC1070, SC1072 - SC1081, SC1083, SC1084, and SC1089
Recalling Firm/
Manufacturer
Abiomed, Inc.
22 Cherry Hill Dr
Danvers, Massachusetts 01923
For Additional Information Contact SAME
978-777-5410
Manufacturer Reason
for Recall
iPulse Console SC1035 displayed a "Low Pressure / Low Flow" alarm and stopped pumping during patient transport in battery operation.
FDA Determined
Cause 2
DESIGN: Device Design
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.
Quantity in Commerce 79
Distribution 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = DSQ and Applicant = ABIOMED CARDIOVASCULAR, INC.
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