Recall Z-0662-2013— Maquet Cardiovascular, LLC

Name: FDA recall Z-0662-2013
Creator: U.S. Food and Drug Administration
Published: 2012-03-27

Class II · Terminated

Class II FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2012-03-27, terminated 2015-09-30. It names one FDA 510(k) clearance: K112372. Product: CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.. Reason: In the Cardiosave Intra-aortic Balloon Pump, there is a possibility that the coiled cord assembly, a prominent connector cord between the Cardiosave IABP housing and the dual display head which secured atop the IABP may fail as a result of mishandling..

Recalling firm: Maquet Cardiovascular, LLC
Classification: Class II
Status: Terminated
Initiated: 2012-03-27
Terminated: 2015-09-30
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K112372 — CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMPCardiac Assist, Maquet Cardiovascular, LLC·cleared 2011-09-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.

Reason for recall

In the Cardiosave Intra-aortic Balloon Pump, there is a possibility that the coiled cord assembly, a prominent connector cord between the Cardiosave IABP housing and the dual display head which secured atop the IABP may fail as a result of mishandling.

Data sourced from openFDA. This site is unofficial and independent of the FDA.