The Recall Desk

Manufacturer

Maquet Cardiovascular Us Sales, Llc

62 recalls in our database name Maquet Cardiovascular Us Sales, Llc as the manufacturing or recalling firm.

What the numbers show

Total
62
Critical
1
Severe
4
Most recent
2020-12-23

Of the 62 recalls from Maquet Cardiovascular Us Sales, Llc we have scored against our rubric, 1 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (6%) 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.

51–62 of 62

  • ModerateFDA (Devices)·Z-0870-2015·2014-12-31

    Maquet Pediatric Oxygenator Recalled for Incorrect Coating Labels on Packaging

    Maquet is recalling 28 units of Quadrox-ID Pediatric Diffusion Membrane Oxygenators because the cartons and shipping containers incorrectly display Softline coating labels instead of Bioline.

    Product
    Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0211-2015·2014-11-19

    Maquet Cardiohelp-I System Recalled for Potential Software Display Error

    Maquet Cardiovascular is recalling 331 Cardiohelp-I Systems due to a software issue that may display an erroneous 'Battery Needs Service' message after startup.

    Product
    Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1165-2014·2014-03-19

    Maquet Plegiox Cardioplegia Heat Exchanger Recalled for Temperature Discrepancy

    Maquet is recalling 1,424 Plegiox Cardioplegia Heat Exchangers because they may fail to reach the desired cardioplegia temperature when used with a heater/cooler unit.

    Product
    MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given temperature range of blood cardioplegic and crystalloid cardioplegic solutions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0848-2014·2014-02-05

    Maquet Compressor Mini Recalled for Excessive Compressed Air Temperature

    Maquet is recalling 237 Compressor Mini units because they may deliver compressed air at a temperature higher than specified.

    Product
    Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the specifications of the compressor mini. compressor mini is intended to be operated by healthcare providers, physicians, nurses, and tech
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2262-2013·2013-10-02

    Maquet Cardiovascular Recalls QUADROX Oxygenators Due to Bond Strength Defects

    Maquet Cardiovascular is recalling specific lots of QUADROX oxygenators used in cardiac surgery because they may not meet specifications for bond strength on connectors.

    Product
    QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2275-2013·2013-10-02

    Maquet Recalls TEGRIS System Due to Missing Emergency Stop Button

    Maquet is recalling 21 TEGRIS systems because a secondary touch screen display lacks an emergency stop button.

    Product
    TEGRIS system Four labels of the Tegris System include: Emergency button (1703.72) MAQUET GmbH & Co. KG Kehler-Strabe 31 Baden-Wuerttemberg 76437 Rastatt, Germany Touch screen (elo) Elo TouchSystems 301 Constitution Drive Menlo Park, CA 94025 www.elotouch.co
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1622-2013·2013-07-10

    Maquet YUNO Mobile Operating Table Recall for Extension Device Handle Issue

    Maquet is recalling YUNO mobile operating tables and extension devices because the handle design may allow operator skin to enter a gap.

    Product
    MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The YUNO OTN is used to support and position patients for surgical procedures immediately before, during and after the surgical phase. The table top is radio translucent and enables intraoperative use of X-
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1572-2013·2013-07-03

    Maquet Pediatric Arterial Cannula Recalled for Incorrectly Sized Connectors

    Maquet is recalling specific pediatric arterial cannula packs because they may contain incorrectly sized connectors. The recall affects 100 units distributed in the US and internationally.

    Product
    MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1177-2013·2013-05-08

    Maquet SERVO-i Ventilator Battery Modules Recalled for Shorter Run Time

    Maquet is recalling SERVO-i ventilator battery modules because some units have shorter battery run times than expected.

    Product
    Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use with the SERVO-i Ventilator System. The SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with respirat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0839-2013·2013-02-27

    Maquet ELS Cannula Recalled for Potential Arterial Lumen Occlusion

    Maquet is recalling ELS 15 FR Cannulas used for infant ECMO because they may contain an occluded arterial lumen.

    Product
    Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0160-2013·2012-11-07

    Maquet Cardiovascular Recalls QUADROX Oxygenators Due to Connector Detachment Risk

    Maquet Cardiovascular is recalling QUADROX oxygenators because the blood outlet connector may detach from the device during use.

    Product
    QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The QUADROX oxygenators are intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1925-2012·2012-07-18

    Maquet FLOW-i Anesthesia System Recalled for Technical Alarm Issue

    Maquet is recalling 284 FLOW-i Anesthesia Systems because a technical alarm may be generated if the MAN/AUTO switch is not fully engaged.

    Product
    FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.
    Category
    Medical Device
    Distribution
    Distributed nationwide