Z-1931-2009

iPulse Circulatory Support System Catalog number: 0036-0010 The iPulse System Console is a multi-purpose...

Name: Z-1931-2009 iPulse Circulatory Support System Catalog number: 0036-0010 The iPulse System Console is a multi-purpose...
Creator: Abiomed, Inc.
Published: 2009-04-23
License: https://open.fda.gov/license/

Abiomed, Inc. / initiated 2009-04-23 / Terminated / root cause: design

FDA source

Abiomed, Inc. began a recall of iPulse Circulatory Support System Catalog number: 0036-0010 The iPulse System Console is a multi-purpose mechanical circulatory support system used to support... on 2009-04-23. The reason FDA records is "iPulse Console SC1035 displayed a "Low Pressure / Low Flow" alarm and stopped pumping during patient transport in battery operation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1931-2009
Status: Terminated
Initiated: 2009-04-23
Posted: 2009-09-16
Terminated: 2014-06-05
Recalling firm: Abiomed, Inc.
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.
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: iPulse Console SC1035 displayed a "Low Pressure / Low Flow" alarm and stopped pumping during patient transport in battery operation.
Root cause tag: design
FDA root cause: 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
Product codes and lots: Serial numbers: SC1000, SC1001, SC1003 - SC1010, SC1014 - SC1023, SC1025 - SC1070, SC1072 - SC1081, SC1083, SC1084, and SC1089

Product code DSQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)