Maquet Cardiovascular Us Sales, Llc

QUADROX-I

FDA Adverse Event

Other ·HAQUET CARDIOPULMONARY AG·Product code DTZ·November 17, 2011

3008355164-2011-00002

FDA Adverse Event

Death ·MAQUET CARDIOVASCULAR US SALES LLC·June 1, 2011

INTRA AORTIC BALLON PUMP

FDA Adverse Event

Injury ·MAQUET CARDIOVASCULAR US SALES LLC / DATASCOPE CORP.·Product code DSP·September 7, 2021

FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.

FDA Recall

Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code BSZ·April 2, 2015

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 hours or less.

FDA Recall

Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DWC·November 13, 2015

Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co.

FDA Recall

Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FQO·June 10, 2015

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.

FDA Recall

Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code MEC·January 16, 2020

Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039

FDA Recall

Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DRE·February 20, 2020

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 to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

FDA Recall

Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DWC·September 27, 2016

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF

FDA Recall

Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019

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.

FDA Recall

Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DTZ·November 20, 2020

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 during extracorporeal circulation. The product is designed for single use only, for an application period of no longer than 6 hours.

FDA Recall

Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DTR·January 31, 2014

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM

FDA Recall

Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP

FDA Recall

Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP

FDA Recall

Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF

FDA Recall

Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019

Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP

FDA Recall

Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code FTD·May 28, 2019

Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203

FDA Recall

Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code MEC·February 10, 2020

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 periods up to six hours), e.g. for intra- and inter-hospital transport. Due to its system combination of integrated oxygenator and centrifugal pump, the HLS Set Advanced is suitable for both extracorporeal pulmonary support and cardiovascular support, and for simultaneous cardiovascular and pulmonary support.

FDA Recall

Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DTQ·March 5, 2015

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 the blood, removes carbon dioxide from the blood and regulates the blood temperature. The oxygenator with diffusion membrane cannot be used for the administration of volatile anesthetic gases because the gas molecules are unable to pass through the diffusion membrane. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.

FDA Recall

Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DTZ·March 5, 2015