| Class 2 Device Recall iPulse Circulatory Support System | |
Date Initiated by Firm | April 23, 2009 |
Date Posted | September 16, 2009 |
Recall Status1 |
Terminated 3 on June 05, 2014 |
Recall Number | Z-1931-2009 |
Recall Event ID |
52200 |
PMA Number | P900023 |
Product Classification |
Ventricular Support System - Product Code DSQ
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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 MA 01923
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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 | 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database | PMAs with Product Code = DSQ
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