RegWardenFDA facility compliance records
Facility

Maquet Cardiovascular LLC

72 recall(s) on record — most severe on record: Class I.

Activity by year

FDA actions on record by year2012: 4 recalls; 2013: 9 recalls; 2014: 4 recalls; 2015: 9 recalls; 2016: 4 recalls, 1 inspections; 2017: 1 recalls; 2018: 1 recalls; 2019: 8 recalls; 2020: 9 recalls; 2021: 1 recalls, 1 inspections; 2022: 4 recalls; 2023: 8 recalls; 2024: 5 recalls, 1 inspections; 2025: 4 recalls; 2026: 1 recalls4’129’134’149’155’161’171’188’199’202’214’228’236’244’251’26
  • Recalls (72)
  • Inspections (3)

Devices registered here (1)

Recalls & enforcement

20261 record
  • Class IIOngoing2026-06-02
    Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.
20254 records
  • Class IIOngoing2025-08-15
    Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
  • Class IIOngoing2025-08-06
    Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws not fully closed out of box, and heater wire lifted/flexed a…
  • Class IIOngoing2025-03-20
    There have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device. The ceramic C-Ring has a potential to break while in use. Maquet/Getinge determined that the issue was limited t…
  • Class IIOngoing2025-03-10
    Incorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up.
20245 records
  • Class IOngoing2024-12-09
    Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
  • Class IIOngoing2024-10-16
    Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.
  • Class IOngoing2024-09-20
    There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use.
  • Class IIOngoing2024-05-31
    There were 27 complaints between March 22, 2024, and April 30, 2024, related to VH-3500 and VH-4000, reporting that the C-Ring wire was straightened (due to insufficient bend radius) and that the distance between C-Ring and Harvesting Tool was closer than normal. No adverse even…
  • Class IIOngoing2024-05-17
    Potential for there to be a fluid ingress into the handle of the harvesting tool, which may lead to the device not providing cautery or providing cautery when not intended.
20238 records
  • Class IOngoing2023-12-13
    Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death…
  • Class IIOngoing2023-12-01
    Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for patients undergoing a coronary artery bypass graft (CABG) or peripheral bypass graf…
  • Class IIOngoing2023-10-31
    The Positioner Arm may not tighten or lock during normal use.
  • Class IIOngoing2023-09-19
    Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.
  • Class IIOngoing2023-09-13
    Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial tissue or vasculature, or a coronary artery or previously placed bypass graft, or could result in procedural delay and/or conversion.
  • Class IIOngoing2023-06-28
    The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conve…
  • Class IIOngoing2023-03-06
    Some batches of product were not sterilized to their minimum sterilization specification.
  • Class IIOngoing2023-01-30
    One (1) Fusion Bioline Vascular graft from lot 25162546, which failed guideline straightness testing, was intermingled with lot 25162549 and distributed to customers. Use of the affected graft may result in reduction of blood flow or unwanted tension causing bleeding and the form…
20224 records
  • Class IIOngoing2022-12-22
    Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event.
  • Class IITerminated2022-04-29
    Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm, contained an Intergard Woven Straight graft of D: 32 mm and L: 30 cm
  • Class IIOngoing2022-02-09
    Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses.
  • Class IITerminated2022-01-14
    Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner) sterile packaging labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Straight Vascular Graft, D: 7 mm L: 60 cm). Mislabeled…
20211 record
  • Class IITerminated2021-12-01
    There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely packaged inside of the carton instead of a Hemashield Gold Knitted Microvel Double Velour Bifurcated…
20209 records
  • Class IITerminated2020-11-20
    The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.
  • Class IITerminated2020-09-30
    The Printed Circuit Board Assembly (PCBA) are not in compliance with the IEC standard (60601 1, third edition). The BMU 40 units affected by this recall were designed with a short creepage distance of 1.8 mm between the two distinct and proximal areas on the printed circuit boa…
  • Class IITerminated2020-09-24
    Plastic socket of the IEC 60320-1 socket pulled out of the metal cage and electronic parts exposed; where the socket was pulled out and main cable is still connected to the main socket (power source), there is a risk that a user or third person may suffer an electric shock when …
  • Class IIITerminated2020-08-07
    Instruction For Use (IFU) references incorrect serial number of 90437000. It should state This document applies to ROTAFLOW Consoles as of serial number 94175452 affected by the implementation of the new IEC standard 60601 1 2, 4th edition
  • Class IITerminated2020-06-18
    Removal for a specific lot, lot number 70128207, of Holder HKHZ 19 for use with QUADROX iD Pediatric Oxygenator. The Holder may not always snap and securely hold the oxygenator as intended.
  • Class IITerminated2020-04-07
    Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
  • Class IITerminated2020-02-20
    A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a material mix-up with the needle portion of the kit; 81 of 255 kits were assembled with an incorrect Arterial Access Needle instead of a Multi-Purpose Procedure Needle.
  • Class IITerminated2020-02-10
    Potential leakage that may occur due to ruptured spot welds in the chamber, could generate a situation for the user such as risk for slipping or infection from contaminated water
  • Class IIITerminated2020-01-16
    Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the units could not be properly installed. There have been no adverse events reported resulting i…
20198 records
  • Class IITerminated2019-12-03
    A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.
  • Class IITerminated2019-07-11
    The sets are configured with quick connectors that have been assembled in reverse on the arterial and venous lines, resulting in blue (venous) to red (arterial) and red (arterial) to blue (venous) connections. Due to this incorrect assembly, the sets cannot be primed from the res…
  • Class IITerminated2019-05-28
    Potential that the coating of the light head forks on the VOLISTA Surgical Lights may crack, posing the risk of particles falling into the surgical field during surgery that may result in patient infection
  • Class IITerminated2019-05-20
    Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse during use result in low water pressure within the circulation system and, in the worst case scenario, can result in the contents of the Washer Disinfector not being clean…
  • Class IITerminated2019-05-06
    User may suffer an electric shock when coming in contact with the exposed electronic components
  • Class IITerminated2019-04-18
    Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance …
  • Class ITerminated2019-02-08
    Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled incorrectly, leading to the inadequate operation of the Emergency Drive.
  • Class IITerminated2019-01-24
    Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).
20181 record
  • Class ITerminated2018-10-25
    There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in clinically relevant loss of prime before patient connection or blood loss during patient connection.
20171 record
  • Class IITerminated2017-01-27
    Maquet has received several complaints involving the VASOVIEW HEMOPRO VH-3500 which involve the device exhibiting the failure mode of intermittent or no power.
20164 records
  • Class IITerminated2016-09-27
    There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.
  • Class IITerminated2016-08-12
    Post Market Surveillance cases reported to Maquet showing instances in which the welded joint between the square mount and the first fixable swivel joint of Maquet's Connecting Bracket (Fixture) Device is broken.
  • Class IITerminated2016-02-23
    Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.
  • Class IITerminated2016-01-07
    MAQUET Medical Systems USA is initiating a field action for correction of the MAQUET Extension Device (Part No 1180.19F0). The Extension Device is manufactured by Maquet GmbH, in Germany, and is a table top module for use with the Maquet MAGNUS operating table system. Maquet Gm…
20159 records
  • Class ITerminated2015-12-10
    Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (PCBs) that control the sub-systems. The problems manifested as multiple re-starts of the sub-systems and, in a few instances, disabling of the system has occurred. Replacement…
  • Class IITerminated2015-11-13
    Failure of the HEATER-COOLER UNIT (HCU 30) Type 2 power supply board. A drop of more than 10% voltage can cause overheating and subsequent failing of the R56 thermistor of the power supply board. Board failure typically occurs when the compressor is switched on (prior to patient …
  • Class IITerminated2015-08-17
    Two serious thromboembolic events were reported involving the Adjustable Positioning Elements (Part Number 1007.28A0) in conjunction with Universal Frame (Part Number 1007.24F0) for lumbar spine surgery. The hip elements may have a negative effect on patients- venous backflow u…
  • Class IITerminated2015-06-10
    There is a potential issue that could result to collision between the C-arm of the angiography system and the MAGNUS OR table system. After switching on the angiography-system, in rare cases, MAGNUS column provides wrong position data for the longitudinal movement leading to a co…
  • Class IITerminated2015-05-29
    Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light Systems may grind at the junction of the suspension arms which can cause paint chips or particles to fall into the surgical field, when the suspension arms are mounted above the surgical table.
  • Class ITerminated2015-04-02
    In some Flow-i Anesthesia Systems, patient cassette can get dislodged which could result in gas leakage within the system internal circuit potentially leading to a stop in ventilation.
  • Class IITerminated2015-03-05
    A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with Bioline and Softline Coatings, Custom Tubing Packs and Diffusion Membrane HLS Set Advanced and HIT Set Advanced Models.
  • Class IITerminated2015-03-02
    Maquet has identified that in some FLOW-i Anesthesia System Auxiliary O2 and Suction Modules, the suctioning function cannot be activated or controlled by the suction unit on/off switch leading to a decrease or loss of suctioning capability of the modules.
  • Class IITerminated2015-01-12
    A calibration problem was detected in a specific number of the Servo-I ventilator system CO2 analyzer models that may have been caused by the module's internal circuit board function.
20144 records
  • Class IITerminated2014-11-05
    Maquet has confirmed through a customer complaint that while the oxygenators and the pouches for a single lot of Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioliine Coating are labeled correctly with the Bioline coating, the individual cartons and 4-pack shipping con…
  • Class IITerminated2014-10-17
    Cardiohelp- i System may have a software issue that can potentially result in an erroneous display of a "Battery Needs Service" message after startup of the units when using either AC or DC power
  • Class IITerminated2014-08-13
    An internal finding identified the presence of pinholes/cuts in some of the Tyvek pouches of the vacuum tubing sets included as an accessory to Acrobat V Vacuum Off-Pump System, Acrobat SUV Vacuum Off-Pump System, Axius XPOSE 3 Access Device and XPOSE 4 Access Device.
  • Class IITerminated2014-01-31
    The MAQUET post-marketing vigilance program has identified a discrepancy that the desired cardioplegia temperature may not be obtained when the PLEGIOX Cardioplegia Heat Exchanger (PLEGIOX) is used in conjunction with a heater/cooler unit.
20139 records
  • Class IITerminated2013-12-05
    Maquet Compressor Mini may deliver compressed air at a temperature higher than specified.
  • Class IITerminated2013-10-30
    Maquet has received an increase in the number of complaints for "self-activated/remains activated/overheats" for the Hemopro VH-30000, "Hemopro 1"
  • Class IITerminated2013-09-20
    MAQUET has identified a potential issue with the ULTIMA OPCAB (part numbers OM-2003S & OM-2001D). Labeling for the 2 blade lots had been incorrectly applied. The standard blades from Lot #25052176 were incorrectly labeled as deep blades, and the 20 deep blades from Lot #2505220…
  • Class IITerminated2013-08-19
    MAQUET has identified a potential issue that might occur because of the lack of an emergency stop button on a secondary touch screen display on the TEGRIS System.
  • Class IITerminated2013-08-15
    The manufacturer has conducted a review of the results of product testing performed during the last twelve months and has identified specific lots of product which may not meet specifications for bond strength on the inlet and/or outlet connector.
  • Class IITerminated2013-05-14
    The specified part numbers and lot numbers of Maquet Pediatric Arterial Cannula Packs may contain an incorrectly sized connector.
  • Class IITerminated2013-04-26
    MAQUET has identified a potential issue with the extension device handle (part number 1433.62A1) and will make enhancements to the YUNO table (part number 1433.01F0). Identification of the Extension device issue: By fully actuating the lever of the extension device handle, th…
  • Class ITerminated2013-03-07
    When using the SERVO-i on battery power, in a very small number of cases, some battery modules distributed after January 31, 2010 have a shorter battery run time than expected.
  • Class IITerminated2013-03-07
    It has come to the attention of MAQUET that there have been episodes of brief unexpected shutdown, followed by an automatic device restart of the human machine interface (touch screen) of the CARDIOHELP device. The human machine interface (HMI) is the central display of the CARD…
20124 records
  • Class IITerminated2012-12-26
    ELS 15 Fr Cannula could potentially contain an occluded arterial lumen.
  • Class IITerminated2012-06-12
    It has come to firm's attention that, in some rare cases, the blood outlet connector on some models of MAQUET Oxygenators may detach from the oxygenator. This event has occurred in about 0.01% (1:10,000) of units shipped.
  • Class IITerminated2012-03-27
    In the Cardiosave Intra-aortic Balloon Pump, there is a possibility that the coiled cord assembly, a prominent connector cord between the Cardiosave IABP housing and the dual display head which secured atop the IABP may fail as a result of mishandling.
  • Class ITerminated2012-02-20
    A technical alarm may be generated on the FLOW-i system when using the MAN/AUTO switch to change ventilation modes from manual to automatic or from automatic to manual if the switch is not fully engaged in the "on" or "off" position but remains in the "in-between position.

FDA inspections (3)

  • OAI2024-07-11
    Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • VAI2021-02-26
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • OAI2016-09-29
    Official Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Maquet Cardiovascular LLC (FEI 2242352) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2242352-maquet-cardiovascular-llc/

Not open yet

Alerts for Maquet Cardiovascular LLC

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.