The Recall Desk

FDA (Devices) recall action 77877

Maquet Datascope Corp - Cardiac Assist Division recalled 3 products on 2017-09-13

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2017-09-13
Critical
0
Units
—

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

1–3 of 3

  • HighFDA (Devices)··2017-09-13

    Maquet CS 100i Intra-Aortic Balloon Pump Recalled for Fluid Ingress

    Maquet Datascope is recalling 14,547 CS 100i Intra-Aortic Balloon Pumps because fluid ingress and false alarms could prevent therapy.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2017-09-13

    Maquet CS 300 Intra-Aortic Balloon Pump Recalled for Fluid Ingress Risk

    Maquet Datascope is recalling CS 300 Intra-Aortic Balloon Pumps because fluid ingress could damage electronic boards, potentially preventing therapy initiation or continuation.

    Product
    CS 300 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 p
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2017-09-13

    Maquet CS 100 Intra-Aortic Balloon Pump Recalled for Electronic Defects

    Maquet Datascope is recalling 14,547 CS 100 Intra-Aortic Balloon Pumps worldwide due to a defect that could prevent therapy initiation or continuation.

    Product
    CS 100 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 p
    Category
    Distribution
    0 states