Recall Z-1931-2009
Abiomed, Inc. · initiated April 23, 2009
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.
Codes / lots: Serial numbers: SC1000, SC1001, SC1003 - SC1010, SC1014 - SC1023, SC1025 - SC1070, SC1072 - SC1081, SC1083, SC1084, and SC1089
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: Device Design
Action taken
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.
Details
- Recall number
- Z-1931-2009
- Initiated
- April 23, 2009
- Posted by FDA
- September 16, 2009
- Terminated
- June 5, 2014
- Product code
- DSQ – Ventricular (Assist) Bypass
- Quantity
- 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
- Recalling firm
- Abiomed, Inc., Danvers, MA