Maquet Cardiovascular Us Sales recalls
Maquet Cardiovascular Us Sales appears in 62 official U.S. recall notices indexed by RecallRadar, most recently on 2020-12-23.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 62 |
|---|---|
| Published | 2012-07-18 to 2020-12-23 |
| By agency | FDA Device (62) |
| By classification | Class II (52), Class I (7), Class III (3) |
| By status | terminated (62) |
| Distribution named in notices | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, MA, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, US, VA, WI, WV |
Recalls
- HLS Set Advanced, Model: BEQ-HLS 7050 USA
FDA Device · Class II · 2020-12-23 · Maquet Cardiovascular Us Sales
Reason: The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier. - HLS Set Advanced Model Name: BEQ-HLS 5050 USA
FDA Device · Class II · 2020-12-23 · Maquet Cardiovascular Us Sales
Reason: The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier. - Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or…
FDA Device · Class II · 2020-11-18 · Maquet Cardiovascular Us Sales
Reason: 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… - Yuno II Mobile Operating Table - Product Usage: support and position the patient immediately before, during and after surgical intervention…
FDA Device · Class II · 2020-10-28 · Maquet Cardiovascular Us Sales
Reason: 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 th… - Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during and after surgical in…
FDA Device · Class II · 2020-10-28 · Maquet Cardiovascular Us Sales
Reason: 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 th… - Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that…
FDA Device · Class III · 2020-09-23 · Maquet Cardiovascular Us Sales
Reason: 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 60… - Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder…
FDA Device · Class II · 2020-08-19 · Maquet Cardiovascular Us Sales
Reason: 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. - Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
FDA Device · Class II · 2020-04-08 · Maquet Cardiovascular Us Sales
Reason: 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-… - Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103
FDA Device · Class II · 2020-03-18 · Maquet Cardiovascular Us Sales
Reason: 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 - Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage: Used in facilities such as Central Sterile Supply De…
FDA Device · Class III · 2020-03-04 · Maquet Cardiovascular Us Sales
Reason: 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 inst… - Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product Usage: Used in facilities such as Central Sterile Supply De…
FDA Device · Class III · 2020-03-04 · Maquet Cardiovascular Us Sales
Reason: 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 inst… - Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161
FDA Device · Class II · 2019-12-18 · Maquet Cardiovascular Us Sales
Reason: A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console. - Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
FDA Device · Class II · 2019-09-25 · Maquet Cardiovascular Us Sales
Reason: 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 th… - Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales
Reason: 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 - Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales
Reason: 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 - Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales
Reason: 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 - Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales
Reason: 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 - Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales
Reason: 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 - Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales
Reason: 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 - Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales
Reason: 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 - Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales
Reason: 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 - Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales
Reason: 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 - Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales
Reason: 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 - Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales
Reason: 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 - Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales
Reason: 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 - Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM
FDA Device · Class II · 2019-07-03 · Maquet Cardiovascular Us Sales
Reason: 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 - Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 Product Usage: The Getinge 86 Series Medical Washer-Disinfector is des…
FDA Device · Class II · 2019-06-19 · Maquet Cardiovascular Us Sales
Reason: 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 res… - Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge 86 Series Medical Washer-Disinfector…
FDA Device · Class II · 2019-06-19 · Maquet Cardiovascular Us Sales
Reason: 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 res… - GETINGE MEERA MOBILE OPERATING TABLE: (1) Part 720001B2 (2) Part 720001B0 (3) Part 720001F2 (4) Part 720001F0 (5) Part 710001B2 (6) Part 71…
FDA Device · Class II · 2019-06-12 · Maquet Cardiovascular Us Sales
Reason: User may suffer an electric shock when coming in contact with the exposed electronic components - Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the…
FDA Device · Class I · 2019-04-03 · Maquet Cardiovascular Us Sales
Reason: 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. - QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207 The membr…
FDA Device · Class I · 2018-12-05 · Maquet Cardiovascular Us Sales
Reason: 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 pa… - QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The me…
FDA Device · Class I · 2018-12-05 · Maquet Cardiovascular Us Sales
Reason: 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 pa… - Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for bl…
FDA Device · Class II · 2016-11-09 · Maquet Cardiovascular Us Sales
Reason: 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. - The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet operati…
FDA Device · Class II · 2016-09-14 · Maquet Cardiovascular Us Sales
Reason: 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. - Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator
FDA Device · Class II · 2016-04-20 · Maquet Cardiovascular Us Sales
Reason: Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products. - QUADROX-i oxygenators Custom tubing packs for the oxygenator
FDA Device · Class II · 2016-04-20 · Maquet Cardiovascular Us Sales
Reason: Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products. - HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
FDA Device · Class II · 2016-04-20 · Maquet Cardiovascular Us Sales
Reason: Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products. - Custom Tubing Packs Custom tubing pack for oxygenators
FDA Device · Class II · 2016-04-20 · Maquet Cardiovascular Us Sales
Reason: Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products. - Maquet Getinge Group 1180.19XO Extension Device
FDA Device · Class II · 2016-03-09 · Maquet Cardiovascular Us Sales
Reason: 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 u… - Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while contro…
FDA Device · Class I · 2016-03-02 · Maquet Cardiovascular Us Sales
Reason: 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… - 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 c…
FDA Device · Class II · 2016-01-13 · Maquet Cardiovascular Us Sales
Reason: 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… - Maquet Getinge Group, Universal Frame for Positioning Patients (1007.24XX) Manufacturer: Maquet GmbH, Germany The MAQUET Adjustable Positio…
FDA Device · Class II · 2015-11-18 · Maquet Cardiovascular Us Sales
Reason: 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 element… - Maquet Getinge Group, Adjustable Positioning Elements (1007.28A0) Manufacturer: Maquet GmbH, Germany
FDA Device · Class II · 2015-11-18 · Maquet Cardiovascular Us Sales
Reason: 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 element… - Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System
FDA Device · Class II · 2015-07-29 · Maquet Cardiovascular Us Sales
Reason: 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 wron… - The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia System: Is indicated for admin…
FDA Device · Class II · 2015-07-22 · Maquet Cardiovascular Us Sales
Reason: 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… - The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the…
FDA Device · Class II · 2015-07-15 · Maquet Cardiovascular Us Sales
Reason: 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 suspensi… - FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient…
FDA Device · Class I · 2015-06-17 · Maquet Cardiovascular Us Sales
Reason: 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. - Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an…
FDA Device · Class II · 2015-06-03 · Maquet Cardiovascular Us Sales
Reason: 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 Diffus… - HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP System in configurat…
FDA Device · Class II · 2015-06-03 · Maquet Cardiovascular Us Sales
Reason: 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 Diffus… - Servo-I ventilator system CO2 analyzer
FDA Device · Class II · 2015-03-11 · Maquet Cardiovascular Us Sales
Reason: 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.