BEUDAMED
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    Terumo Custom Cardiovascular Procedure Kit (manufactured to the design and specifications of the purchaser/user) for the application it is intended by the user. X-COATED CHANGE OUT PACK WITH FX15E Product Code: 74257

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTZ·April 12, 2012

    Terumo Custom Cardiovascular Procedure Kit-PEDIATRIC PACK Product Code: 71062-01 Manufactured to the design and specifications of the purchaser/user) for the application it is intended.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTZ·April 12, 2012

    Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended. X-COATED FX15 ADULT PACK Product Code: 73399

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTZ·April 12, 2012

    Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended. Cardiovascular Custom Procedure Kit Adult Product Code: 71060-01

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTZ·April 12, 2012

    Cobe CML Duo Flat Sheet Membrane Oxygenator, sterile, (Custom Heart/Lung Packs), Catalog numbers: 067100001, 078002103, 078005802, 078159025, 078201013, 078212009, 078310006, 078332022, 078348014, 078428010, 078688007, 078869003. COBE Cardiovascular, Inc..

    FDA Recall
    Terminated ·Cobe Cardiovascular, Inc·Product code DTZ·June 26, 2006

    Cobe Optimin Hollow Fiber Sealed System, Oxygenator/Reservoir, Sterile, (Standalone systems), Catalog numbers:050125400, 050502000. COBE Cardiovascular, Inc..

    FDA Recall
    Terminated ·Cobe Cardiovascular, Inc·Product code DTZ·June 26, 2006

    Dideco, D901 Lilliput 1, Close Phisio, Sterile EO, REF 05252, Manufacturer: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) (Italy). The product is intended for use in cardiopulmonary bypass circuits as a device to replace the function of the lungs in order to control the arterial/venous temperature and as a venous blood reservoir

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DTZ·August 8, 2008

    Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affinity Fusion Oxygenator with Integrated Arterial Filter with or without the Cardiotomy/Venous Reservoir with Balance1 Biosurface is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

    FDA Recall
    Terminated ·Medtronic Inc·Product code DTZ·November 16, 2016

    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

    NAMIC Custom Angiographic Kit, Right Heart Kit, REF/Catalog # 60190254, Sterile, and bulk Non-Sterile Manifolds Assemblies, Product #s 40338200 and 40336200 (foreign product for further processing, e.g., packaging, labeling, sterilization, and distribution under BSC). Manufactured by: Boston Scientific Corporation/NAMIC Technology Center/Glens Falls, New York 12801. Angiographic Manifolds are intended for use in fluid management and/or invasive pressure monitoring systems. Procedures in which angiographic manifold may be used include hemodynamic pressure monitoring and intra-arterial and intravenous administration of water based solutions or radiographic contrast media.

    FDA Recall
    Terminated ·Navilyst Medical·Product code DTZ·August 6, 2008

    Endura No-React Dural Substitute 6 cm x 10 cm

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code DTZ·May 4, 2007

    Cobe Optima XP Hollow Fiber Membrane Oxygenator, Sterile, (Custom Heart/Lung Packs), Catalog Numbers: 028901008, 032794001, 067129002, 067149006, 067174002, 067188002, 067212004, 067221009, 067236004, 067260001, 067296002, 067351006, 067354002, 067388004, 067434005, 067442001, 067447010, 067452001, 067458005, 067481003, 06748002, 067523001, 067529002, 067536002, 067539005, 067570003, 067577001, 067594003, 067602001, 067614005, 067625001, 067634005, 067662002, 067668001, 067682001, 067683003, 067686005, 067694002, 067709001, 067710001, 067714001, 067721002, 067722001, 067735002, 078011601, 078011701, 078014002, 078107009, 078149017, 078183015, 078196012, 078249006, 078280017, 078346013, 078351010, 078399009, 078439012, 078522010, 078534012, 078541004, 078549011, 078574008, 078707005, 078766004, 078892004, 078898003, 078909002, 0789337004, 078959005, 078987001, 078988002, 07896006. COBE Cardiovascular, Inc..

    FDA Recall
    Terminated ·Cobe Cardiovascular, Inc·Product code DTZ·June 26, 2006

    Apex HP Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) Italy. Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DTZ·December 2, 2011

    Terumo Cardiovascular Systems CAPIOX (r) SX18 Hollow Fiber Oxygenator LOT: HF22 . 2010-04 The X-coated Capiox SX18 Hollow Fiber Oxygenators with Detachable Hardshell Reservoir are used to exchange gases between extracorporeal blood and a gaseous environment during cardiopulmonary bypass procedures. The integral heat exchanger is used to warm or cool the blood or perfusion fluid and the detachable hardshell reservoir is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal.

    FDA Recall
    Terminated ·Terumo Cardiovascular Corporation·Product code DTZ·June 28, 2010

    Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended. X-COATED FX15RE40 PACK Product Code: 73484

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTZ·April 12, 2012

    Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTZ·June 14, 2019

    Extra corporeal circuit with bio-active surface.

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DTZ·August 8, 2018

    Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with Trillium Biopassive Surface (on the oxygenator), Model 541T-R

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DTZ·March 25, 2004

    EnDura No React Dural Substitute 10 cm x 12 cm

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code DTZ·May 4, 2007

    Cobe CML Duo Flat Sheet Membrane Oxygenator/Reservoir, sterile, (Standalone systems). Catalog Numbers: 050226400, 050422400. COBE Cardiovascular, Inc..

    FDA Recall
    Terminated ·Cobe Cardiovascular, Inc·Product code DTZ·June 26, 2006