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    Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers 45-651026 and 45-652050, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.

    FDA Enforcement
    Class II ·Terminated·Microvention, Inc.·February 19, 2020

    Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and 45-680820, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.

    FDA Enforcement
    Class II ·Terminated·Microvention, Inc.·February 19, 2020

    The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Procedure kits are packaged individually.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·March 1, 2017

    Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit Single/Sterile Terumo Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of micro-emboli greater than 40 microns in size, including gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris from the arterial line and where the flow rate will not exceed 8 liters per minute. Cardiovascular Procedure (Convenience) Kit that includes the Terumo Pall AL6X Arterial Filter: The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed. The sterile cardiovascular procedure kit is intended to be used one time for periods up to 6 hours.

    FDA Enforcement
    Class II ·Terminated·Terumo Cardiovascular Systems Corporation·October 2, 2013

    Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, REF numbers 45-451015, 45-451020, 45-451215, 45-451220, 45-451230, 45-451520, 45-451530, 45-452020, 45-452030, 45-450410, 45-450415, 45-450405, 45-450610, 45-450615, 45-450620, 45-450815, 45-450820, and MV-AZ52030HD, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.

    FDA Enforcement
    Class II ·Terminated·Microvention, Inc.·February 19, 2020

    Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45-751019, 45-751324, 45-751632, 45-752039, 45-750407, 45-750511, 45-750617, 45-750609, 45-750812, 45-750824, MV-AX50407CD, MV-AX50511CD, MV-AX50617CD, MV-AX50824CD, and MV-AX51019CD, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.

    FDA Enforcement
    Class II ·Terminated·Microvention, Inc.·February 19, 2020

    Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System, REF numbers 45-481015, 45-481020, 45-481215, 45-481220, 45-481515, 45-481520, 45-482020, 45-482030, 45-480202, 45-480204, 45-480310, 45-480302, 45-480305, 45-480410, 45-480415, 45-480420, 45-480405, 45-480610, 45-480615, 45-480620, 45-480815, 45-480820, MV-AZ80520HL, MV-AZ80202HL, MV-AZ80204HL, MV-AZ80305HL, MV-AZ80310HL, MV-AZ80410HL, MV-AZ80420HL, MV-AZ80620HL, MV-AZ80820HL, and MV-AZ81020HL, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.

    FDA Enforcement
    Class II ·Terminated·Microvention, Inc.·February 19, 2020

    MISAGO RX Self Expanding Peripheral Stem

    FDA Recall
    Terminated ·Terumo Medical Corp·Product code NIP·August 4, 2016

    Terumo(tm) Hypodermic Needle, sterile, individually packaged into a "blister-pack" flexible plastic bottom-web thermo-formed to create a pocket, heat-sealed with paper top-web,1,000 needles per case. Product Usage: Aspiration and injection of fluids for medical purposes.

    FDA Recall
    Terminated ·Terumo Medical Corporation·Product code FMI·June 8, 2010

    Terumo Sarns Level Sensor II Pads. Terumo Cardiovascular Systems Corporation. Used to attach level sensors to the sides of the venous reservoir.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code KRI·August 12, 2011

    Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.

    FDA Recall
    Terminated ·Terumo Medical Corp·Product code MEG·November 23, 2015

    Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers 45-651026 and 45-652050, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.

    FDA Recall
    Terminated ·Microvention, Inc.·Product code KRD·November 24, 2019

    Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and 45-680820, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.

    FDA Recall
    Terminated ·Microvention, Inc.·Product code KRD·November 24, 2019

    Terumo Clirans Series EE Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (28 microns thick) of vitamin E coated copolymer cellulose housed within a polyurethane casing, filled at the factory with fluid to facilitate priming by the user, and sterilized by autoclaving before shipment; Terumo Corporation, Tokyo 151-0072, Japan; Terumo Medical Corporation, Somerset, NJ 08873 U.S.A.; Made in Japan, 24 units per case; Models CL*EE12NLA - 1.2 m2 surface area, CL*EE15NLA - 1.5 m2 surface area and CL*EE20NLA - 2.0 m2 surface area

    FDA Recall
    Terminated ·Asahi Medical Co Ltd 1-1 Uchiauwaicho, 1-Chome 14 Flr, Imperial Tower Bldg Chiyoda Ku Japan·Product code KDI·March 31, 2005

    Terumo Clirans Series E Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (23 microns thick) of vitamin E coated copolymer cellulose housed within a polyurethane casing, filled at the factory with fluid to facilitate priming by the user, and sterilized by autoclaving before shipment; Terumo Corporation, Tokyo 151-0072, Japan; Terumo Medical Corporation, Somerset, NJ 08873 U.S.A.; Made in Japan, 24 units per case; Models CL*E12NLA - 1.2 m2 surface area, CL*E15NLA - 1.5 m2 surface area, CL*E18NLA - 1.8 m2 surface area and CL*E20NLA - 2.0 m2 surface area

    FDA Recall
    Terminated ·Asahi Medical Co Ltd 1-1 Uchiauwaicho, 1-Chome 14 Flr, Imperial Tower Bldg Chiyoda Ku Japan·Product code KDI·March 31, 2005

    Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWC·March 16, 2018

    Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45-751019, 45-751324, 45-751632, 45-752039, 45-750407, 45-750511, 45-750617, 45-750609, 45-750812, 45-750824, MV-AX50407CD, MV-AX50511CD, MV-AX50617CD, MV-AX50824CD, and MV-AX51019CD, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.

    FDA Recall
    Terminated ·Microvention, Inc.·Product code KRD·November 24, 2019

    Terumo AZUR Peripheral Coil System, Detachable 35, Helical HydroCoil Embolization System, REF numbers 45-451015, 45-451020, 45-451215, 45-451220, 45-451230, 45-451520, 45-451530, 45-452020, 45-452030, 45-450410, 45-450415, 45-450405, 45-450610, 45-450615, 45-450620, 45-450815, 45-450820, and MV-AZ52030HD, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.

    FDA Recall
    Terminated ·Microvention, Inc.·Product code KRD·November 24, 2019

    CAPIOX Flexible Venous Reservoirs, 1500 mL, product codes: CXFVR1500X and CXFVRI500XC, used singly or packaged as components in cardiovascular procedure trays labeled in part ***Terumo Caerdiovascular Systems Corporation, Elkton, MD 21921*** Product Usage: The reservoir bag is intended for use as a blood collection and storage device during cardiopulmonary bypass procedures. The device is intended for use in conjunction with blood-gas oxygenators in the extra-corporeal circuit. The device may be used in procedures lasting up to 6 hours.

    FDA Recall
    Terminated ·Terumo Cardiovascular Corporation·Product code DTN·July 21, 2011

    804115, Terumo Coronary Ostia cannula, 10 Fr, 10 (25 cm) long A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWF·May 16, 2011