The Recall Desk

Manufacturer

Maquet Datascope Corp - Cardiac Assist Division

14 recalls in our database name Maquet Datascope Corp - Cardiac Assist Division as the manufacturing or recalling firm.

What the numbers show

Total
14
Critical
3
Severe
4
Most recent
2018-11-07

Of the 14 recalls from Maquet Datascope Corp - Cardiac Assist Division we have scored against our rubric, 3 (21%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (29%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–14 of 14

  • SevereFDA (Devices)·Z-1928-2018·2018-06-06

    Maquet Datascope Recalls CARDIOSAVE Hybrid Intra-Aortic Balloon Pumps

    Maquet Datascope is recalling CARDIOSAVE Hybrid Intra-Aortic Balloon Pumps because fluid ingress can damage electronic circuit boards, preventing therapy initiation or continuation.

    Product
    CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179
    Category
    Medical Device
    Distribution
    50 states
  • SevereFDA (Devices)·Z-3086-2017·2017-09-13

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3085-2017·2017-09-13

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3087-2017·2017-09-13

    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
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2738-2017·2017-08-02

    Maquet CS 300 Intra-Aortic Balloon Pump Recalled Due to Device Failure

    Maquet Datascope is recalling 12,319 CS 300 Intra-Aortic Balloon Pumps because electrical test failures caused the device to fail to pump, which has been associated with a patient death.

    Product
    CS 300 Intra-Aortic Balloon Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2736-2017·2017-08-02

    Maquet CS 100i Intra-Aortic Balloon Pump Recalled Due to Device Failure

    Maquet Datascope is recalling 12,319 CS 100i Intra-Aortic Balloon Pumps because electrical failures prevented the device from initiating therapy, which has been associated with a patient death.

    Product
    CS 100i Intra-Aortic Balloon Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2737-2017·2017-08-02

    Maquet CS 100 Intra-Aortic Balloon Pump Recalled Due to Device Failure

    Maquet Datascope is recalling 12,319 CS 100 Intra-Aortic Balloon Pumps because electrical and autofill failures prevented the device from initiating therapy, which has been associated with a patient death.

    Product
    CS 100 Intra-Aortic Balloon Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1386-2017·2017-03-08

    Maquet CARDIOSAVE IABP Li-Ion Battery Recall Due to Venting Risk

    Maquet is recalling Li-Ion batteries for CARDIOSAVE IABP devices after reports of venting when dropped.

    Product
    CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1248-2016·2016-04-06

    Maquet Recalls Cardiosave Hybrid and Rescue IABP Devices

    Maquet is recalling Cardiosave Hybrid and Rescue IABP devices because the scroll compressor may not meet specifications for output pressure or vacuum at specific flow rates.

    Product
    Cardiosave Hybrid and rescue IABP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1062-2015·2015-02-18

    Maquet Intra-Aortic Balloon Pump Demonstration Units Recalled for Ferrule Cap Defect

    Maquet Datascope is recalling specific intra-aortic balloon pump demonstration units because a ferrule cap was not removed, which could prevent connection or become dislodged in the device.

    Product
    CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx An electromechanical system use
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1523-2014·2014-05-28

    Maquet Datascope Intra-Aortic Balloon Pump Recall for Fan Assembly Failure

    Maquet Datascope is recalling 11,881 Intra-Aortic Balloon Pump units worldwide due to a potential fan assembly failure that could cause the power supply to overheat and shut down without warning.

    Product
    Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide