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.

1–25 of 62

  • HighFDA (Devices)·Z-0633-2021·2020-12-23

    Maquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breach

    Maquet Cardiovascular is recalling the HLS Set Advanced because of breaches in the product's sterility barrier. The device is used with the CARDIOHELP system for cardiac and pulmonary support.

    Product
    HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0632-2021·2020-12-23

    Maquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breaches

    Maquet Cardiovascular is recalling HLS Set Advanced devices used for cardiac support due to breaches in the product's sterility barrier.

    Product
    HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0443-2021·2020-11-18

    Maquet BMU 40 Blood Monitoring Units Recalled for Electrical Safety Non-Compliance

    Maquet Cardiovascular is recalling 51 Blood Monitoring Units (BMU 40) because the printed circuit boards do not meet IEC electrical safety standards for creepage distance.

    Product
    Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters: parti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0132-2021·2020-10-28

    Maquet Yuno Mobile Operating Table Recalled for Electric Shock Risk

    Maquet is recalling Yuno Mobile Operating Tables because a plastic socket may pull out, exposing electronic parts and creating an electric shock hazard.

    Product
    Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143301F0 (US) Part 143301B0 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0133-2021·2020-10-28

    Maquet Yuno II Mobile Operating Table Recalled for Electric Shock Risk

    Maquet is recalling Yuno II Mobile Operating Tables because a plastic socket may pull out, exposing electronic parts and creating an electric shock hazard.

    Product
    Yuno II Mobile Operating Table - Product Usage: support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Part 143302F0 (US) Part 143302B0 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2957-2020·2020-09-23

    Maquet Rotaflow System Console Instructions for Use Recall

    Maquet Cardiovascular is recalling Instructions for Use for the Rotaflow System Console because the documents reference an incorrect serial number.

    Product
    Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit Material Number: 701043292
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2780-2020·2020-08-19

    Maquet Holder HKHZ 19 Recalled for Insecure Oxygenator Fit

    Maquet is recalling Holder HKHZ 19 units for Quadrox-i and Quadrox-iD oxygenators because the holder may not securely hold the oxygenator.

    Product
    Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder HKHZ 19 is an accessory to QUADROX i and QUADROX iD Neonatal / Pediatric oxygenator and is being used as a single holder for QUADROX i and QU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1603-2020·2020-04-08

    Maquet Recalls Avalon Elite Vascular Access Kits Due to Needle Mix-up

    Maquet is recalling 255 Avalon Elite Vascular Access Kits because 81 units were assembled with an incorrect arterial needle instead of a multi-purpose needle.

    Product
    Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1475-2020·2020-03-18

    Getinge 88-Series Washer Disinfectors Recalled for Chamber Leakage Risk

    Maquet Cardiovascular is recalling Getinge 88-Series washer disinfectors because ruptured spot welds may cause water leakage, posing slip and infection risks.

    Product
    Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1390-2020·2020-03-04

    Getinge 46-Series Washer Disinfector Recalled Due to Missing Water Intake Components

    Maquet Cardiovascular is recalling four Getinge 46-Series Washer Disinfector units because they lack necessary water intake components, preventing proper installation.

    Product
    Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-1391-2020·2020-03-04

    Getinge 46-Series Washer Disinfector Recalled Due to Missing Water Intake

    Maquet Cardiovascular is recalling 7 Getinge 46-Series Washer Disinfector units because they lack the necessary water intake components for proper installation.

    Product
    Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0678-2020·2019-12-18

    Maquet ROTAFLOW Drive Recalled for Loose Cable Connection

    Maquet is recalling 11 ROTAFLOW Drive units because a loose cable connection may cause fluctuating flow values on the console.

    Product
    Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2149-2019·2019-09-25

    Maquet Cardiopulmonary Sets Recalled Due to Incorrect Quick Connector Assembly

    Maquet is recalling 54 cardiopulmonary sets because quick connectors were assembled in reverse, preventing proper priming and function.

    Product
    Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-1855-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled Due to Coating Crack Risk

    Maquet is recalling 46 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, risking particle contamination in the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1861-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling five VOLISTA StandOP Surgical Lights because light head fork coatings may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1863-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling 9 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1852-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

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

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1854-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled Due to Coating Crack Risk

    Maquet is recalling 65 VOLISTA StandOP Surgical Lights because the coating on the light head forks may crack, posing a risk of particles falling into the surgical field and causing patient infection.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1856-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling 7 units of 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: ARD568812910 Model: VLT400SF STP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1862-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling two VOLISTA StandOP Surgical Lights because the light head fork coating may crack, posing a risk of particles falling into the surgical field and causing patient infection.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1857-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

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

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1860-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling 11 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1859-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling 12 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1864-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling 10 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, potentially dropping particles into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF
    Category
    Medical Device
    Distribution
    Distributed nationwide