Recall Z-3085-2017— Maquet Datascope Corp - Cardiac Assist Division

Name: FDA recall Z-3085-2017
Creator: U.S. Food and Drug Administration
Published: 2017-07-17

Class I · Ongoing

Class I FDA medical device recall by Maquet Datascope Corp - Cardiac Assist Division, initiated 2017-07-17. It names one FDA 510(k) clearance: K031636. Product: CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle.. Reason: False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy..

Recalling firm: Maquet Datascope Corp - Cardiac Assist Division
Classification: Class I
Status: Ongoing
Initiated: 2017-07-17
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K031636 — CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XXDatascope Corp.·cleared 2003-08-11

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

CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle.

Reason for recall

False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy.

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