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.

26–50 of 62

  • HighFDA (Devices)·Z-1858-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling six VOLISTA StandOP Surgical Lights because the coating on the light head forks may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1777-2019·2019-06-19

    Getinge 86-Series Medical Washer-Disinfector Recalled for Potential Hose Collapse

    Maquet Cardiovascular is recalling four Getinge 86-Series Medical Washer-Disinfector units because the inlet pump hose may collapse, potentially preventing proper cleaning of medical instruments.

    Product
    Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1778-2019·2019-06-19

    Getinge 86-Series Medical Washer-Disinfector Recalled for Potential Hose Collapse

    Maquet Cardiovascular is recalling 40 Getinge 86-Series Medical Washer-Disinfector units because the inlet pump hose may collapse, potentially preventing proper cleaning of medical instruments.

    Product
    Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 Product Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1734-2019·2019-06-12

    Getinge Meera Mobile Operating Table Recalled for Electric Shock Risk

    Maquet Cardiovascular is recalling Getinge Meera Mobile Operating Tables because exposed electronic components may cause electric shock to users.

    Product
    GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part 710001B2 (6) Part 710001B0 (7) Part 710001F0 Product Usage: The Meera Mobile Operating Table is designed to support and position the patient im
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0986-2019·2019-04-03

    Maquet Cardiohelp Emergency Drive Recalled for Gearwheel Assembly Defect

    Maquet Cardiovascular is recalling 10 units of the Cardiohelp Emergency Drive because the gearwheel may have been incorrectly reassembled, leading to inadequate operation.

    Product
    Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0437-2019·2018-12-05

    Maquet Cardiovascular Recalls QUADROX-i Neonatal Membrane Oxygenators

    Maquet Cardiovascular is recalling QUADROX-i Neonatal membrane oxygenators due to a potential for blood leakage at the blood inlet connector when using a specific reducing screw adapter.

    Product
    QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0436-2019·2018-12-05

    Maquet QUADROX-i Neonatal Membrane Oxygenator Recalled for Blood Leakage Risk

    Maquet is recalling QUADROX-i Neonatal membrane oxygenators because a specific reducing screw adapter may cause blood leakage at the inlet connector.

    Product
    QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0348-2017·2016-11-09

    Maquet HCU 30 Heater-Cooler Units Recalled for Bacterial Contamination Risk

    Maquet Cardiovascular is recalling 305 HCU 30 units because contaminated water, including Mycobacteria, may enter the device circuits.

    Product
    Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled. The HCU 30 is intended t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2746-2016·2016-09-14

    Maquet Operating Room Table Connecting Bracket Recall for Welded Joint Failure

    Maquet is recalling Connecting Bracket (Fixture) Devices because post-market surveillance reports indicate the welded joint between the square mount and the first fixable swivel joint is broken.

    Product
    The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet operating room table immediately before, during and after surgical interventions as well as for examination and treatment. The fixture is used to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1373-2016·2016-04-20

    Maquet Rotaflow Centrifugal Pump Tubing Recalled for Endotoxin Risk

    Maquet Cardiovascular is voluntarily recalling Rotaflow Centrifugal Pump custom tubing packs due to a potential risk of endotoxin exposure.

    Product
    Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1374-2016·2016-04-20

    Maquet Custom Tubing Packs Recalled for Potential Endotoxin Exposure

    Maquet Cardiovascular is voluntarily recalling 72,000 custom tubing packs for oxygenators due to a potential risk of endotoxin exposure.

    Product
    Custom Tubing Packs Custom tubing pack for oxygenators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1371-2016·2016-04-20

    Maquet QUADROX-i oxygenators recalled for potential endotoxin exposure

    Maquet Cardiovascular is voluntarily recalling QUADROX-i oxygenators and tubing packs due to a potential risk of endotoxin exposure.

    Product
    QUADROX-i oxygenators Custom tubing packs for the oxygenator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1372-2016·2016-04-20

    Maquet Recalls HLS Set Advanced Oxygenator Tubing Packs Due to Endotoxin Risk

    Maquet Cardiovascular is voluntarily recalling HLS Set Advanced oxygenator tubing packs due to a potential risk of exposure to endotoxin.

    Product
    HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1045-2016·2016-03-09

    Maquet Extension Device Recalled for Potential Detachment from Operating Table

    Maquet is recalling the 1180.19F0 Extension Device because it may unlock and fall from the MAGNUS operating table.

    Product
    Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, Used to support the upper and lower extremities immediately before, during and after fracture surgery. The Extension Device (1180.19F0) is a table top module for use with the Maquet MAGNUS operating tab
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0804-2016·2016-03-02

    Maquet Flow-i Anesthesia System Recalled for Electrical Control Issues

    Maquet is recalling seven Flow-i Anesthesia Systems in the US due to electrical issues in control and monitoring sub-systems that can cause restarts or system disabling.

    Product
    Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0589-2016·2016-01-13

    Maquet HCU 30 Heater-Cooler Unit Recalled for Power Supply Board Failure

    Maquet is recalling HCU 30 Heater-Cooler Units due to a power supply board defect that can cause overheating and unit shutdown during cardiopulmonary bypass procedures.

    Product
    Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0247-2016·2015-11-18

    Maquet Adjustable Positioning Elements Recalled Due to Thromboembolic Events

    Maquet is recalling Adjustable Positioning Elements used in spine surgery after two serious thromboembolic events were reported.

    Product
    Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet GmbH, Germany. Patient positioners. The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0248-2016·2015-11-18

    Maquet Universal Frame Recalled Due to Thromboembolic Event Reports

    Maquet is recalling Universal Frames and Adjustable Positioning Elements after two serious thromboembolic events were reported during lumbar spine surgery.

    Product
    Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany The MAQUET Adjustable Positioning Elements are designed for the placement and positioning of patients in the prone position immediately before, during and after surgical
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2097-2015·2015-07-29

    Maquet Magnus Hybrid OR Table Column Recalled for Collision Risk

    Maquet is recalling 12 Magnus Hybrid OR Table Columns due to a potential collision risk with the C-arm of the Siemens Artis Zeego Angiography System.

    Product
    Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2083-2015·2015-07-22

    Maquet Recalls FLOW-i Anesthesia System Modules Due to Suction Failure

    Maquet is recalling 104 FLOW-i Anesthesia System Auxiliary O2 and Suction Modules because the suction function may not activate or be controlled by the switch.

    Product
    The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia System: Is indicated for administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1990-2015·2015-07-15

    Maquet Surgical Light Suspension Arms Recalled for Debris Risk

    Maquet is recalling 646 PowerLED, X-TEN, and VOLISTA surgical light systems because suspension arms may grind and release paint chips into the surgical field.

    Product
    The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems typically include one or more arms that are able to rotate 360 degrees around a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1706-2015·2015-06-17

    Maquet FLOW-i Anesthesia System Recalled for Gas Leakage Risk

    Maquet is recalling FLOW-i Anesthesia Systems because a dislodged patient cassette can cause gas leakage and stop ventilation.

    Product
    FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1689-2015·2015-06-03

    Maquet Quadrox-iD Adult Diffusion Membrane Oxygenator Recalled for Blood Leakage Risk

    Maquet Cardiovascular is recalling Quadrox-iD Adult Diffusion Membrane Oxygenators due to a potential issue that could result in blood leakage from the gas outlet port.

    Product
    Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1690-2015·2015-06-03

    Maquet Cardiovascular Recalls HLS/HIT Set Advanced Due to Blood Leakage Risk

    Maquet Cardiovascular is recalling HLS/HIT Set Advanced consoles because a potential issue could cause blood to leak from the gas outlet port.

    Product
    HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for peri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1224-2015·2015-03-11

    Maquet Servo-I Ventilator CO2 Analyzer Recalled for Calibration Defect

    Maquet is recalling 486 Servo-I ventilator CO2 analyzers worldwide due to a calibration problem caused by an internal circuit board defect.

    Product
    Servo-I ventilator system CO2 analyzer. Part number 65 23 588.
    Category
    Medical Device
    Distribution
    Distributed nationwide