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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET accessories with the dovetail guide interface immediately before, during and after surgical interventions as well as for examination and treatment.
FDA Enforcement
Class II
·Terminated·Maquet Medical Systems USA·November 16, 2016
Alm Prismatic Surgical Light 5004 SF; Maquet SA. ALM PRISMATIC (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is designed to eliminate shadow, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures.
FDA Recall
Terminated
·MAQUET Inc.·Product code FTD·February 23, 2009
ALM Prismatic Surgical Light 9551 DF; Maquet SA. ALM PRISMATIC (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is designed to eliminate shadow, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures.
FDA Recall
Terminated
·MAQUET Inc.·Product code FTD·February 23, 2009
Servo Ventilator 300 (Model SV300) and Servo Ventilator 300 (Model SV300A). The SV300 is intended for general and critical ventilatory care for use on adults, pediatric, infant and neonatal patients. The unit is designed to be used at the bedside for intra-hospital transport.
FDA Recall
Terminated
·MAQUET Inc.·Product code CBK·March 23, 2009
Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone +49 7222 932-0 Fax: +49 7222 932-1888 [email protected] www.maquet.com Used to introduce blood and sterile solution to the circulation system during extracorporeal circulation procedures
FDA Enforcement
Class II
·Terminated·Maquet Inc.·August 22, 2012
Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt,Germany Used to support the lower extremities immediately before during and after surgery. The extension device is mounted to the YUNO operating table. The product may only be operated by medically trained staff within the OR environment.
FDA Enforcement
Class II
·Terminated·Maquet Inc.·January 9, 2013
Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter).
FDA Recall
Terminated
·Maquet Inc·Product code DWF·May 20, 2005
Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
FDA Recall
Terminated
·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·January 30, 2015
Foot switch, Part Number 1009.81. Maquet GmbH & Co. KG, 76437 Rastatt, Germany. The foot switches in the 1009.8 1 series are accessory components which can be connected to certain MAQUET operating tables. Several of the table top adjustment motions (depending on the table and foot switch versions in use) can then be executed by the foot. The foot switch is equipped with rocker switches. The switching elements are used to initiate the table top functions.
FDA Recall
Terminated
·MAQUET Inc.·Product code FWZ·December 8, 2008
LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group
FDA Recall
Terminated
·Datascope Corporation·Product code DSP·August 11, 2014
Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature.
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code DTZ·November 5, 2014
Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code DTQ·October 17, 2014
Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET accessories with the dovetail guide interface immediately before, during and after surgical interventions as well as for examination and treatment.
FDA Recall
Terminated
·Maquet Medical Systems USA·Product code FQO·October 5, 2016
HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code DTQ·February 23, 2016
QUADROX-i oxygenators Custom tubing packs for the oxygenator
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code DTZ·February 23, 2016
Custom Tubing Packs Custom tubing pack for oxygenators
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code KFM·February 23, 2016
Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code KFM·February 23, 2016
VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usage: The VASOVIEW HEMOPRO VH-3500 is designed for use in conjunction with the 7-mm Endoscope and is intended for specific use with the VASOVIEW HEMOPRO Power Supply.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code GEI·January 27, 2017
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
Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of cardiac surgical procedures through a sternotomy incision approach.
FDA Recall
Terminated
·Maquet Cardiovascular, LLC·Product code MWS·August 13, 2014