BEUDAMED
    83 results · 21ms · Sources: EU EUDAMED, US FDA

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    StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.

    FDA Recall
    Terminated ·Abbott Vascular·Product code MGB·February 10, 2017

    Peripheral Dilatation Catheter, Viatrac 14 Plus 5.0mm x 15mm x 80cm, Part Number 1008194-15. Manufactured by Abbott Vascular, Temecula, CA. Indicated to dilate stenosis in the peripheral vasculature and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

    FDA Recall
    Terminated ·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code LIT·May 6, 2009

    MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the Clip Delivery System, product number CDS0201, GTIN 08717648195914 and the Steerable Guide Catheter, product number SGC0101, GTIN 08717648195921. The MitraClip Clip Delivery System (CDS) consists of three major components: 1) the Delivery Catheter 2) the Steerable Sleeve, and 3) the MitraClip device. The implantable MitraClip device is located at the distal end of the CDS. The CDS is used to advance and manipulate the implantable MitraClip device for proper positioning and placement on the mitral valve leaflets. The Delivery Catheter, which is part of the CDS, is designed to deliver and deploy the MitraClip. The Delivery Catheter extends through the thru-lumen of the Steerable Sleeve.

    FDA Recall
    Terminated ·Abbott Vascular·Product code NKM·February 4, 2016

    RX ACCULINK Carotid Stent System, 10x40 mm, Product Number: 1011344-40, Lot Number: 9081851. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.

    FDA Recall
    Terminated ·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code NIM·October 1, 2009

    POWERSAIL Coronary Dilatation Catheter: 3.25x18mm (US) Part #1005524-18

    FDA Recall
    Terminated ·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code MAF·June 17, 2009

    POWERSAIL Coronary Dilatation Catheter: 4.0x8mm (CE) Part #1005726-08

    FDA Recall
    Terminated ·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code MAF·June 17, 2009

    POWERSAIL Coronary Dilatation Catheter: 2.75x18mm (US) Part #1005522-18

    FDA Recall
    Terminated ·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code MAF·June 17, 2009

    POWERSAIL Coronary Dilatation Catheter: 3.25x8mm (US) Part #1005524-08

    FDA Recall
    Terminated ·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code MAF·June 17, 2009

    Abbott Vascular, StarClose Vascular Closure System Part Number 14677-01, for closure of femoral artery access sites after cardiovascular catheterization.

    FDA Recall
    Terminated ·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code MGB·May 6, 2009

    RX ACCULINK Carotid Stent System 10 X 20mm, Part Number: 1011342-20, Lot Number: 0072061 The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. (1) Patients with neurological symptoms and >50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and >80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND (2) Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.

    FDA Recall
    Terminated ·Abbott Vascular·Product code NIM·September 10, 2010

    RX ACCULINK Carotid Stent System 9 X 20mm, Part Number: 1011341-20, Lot Number: 0071361 The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. (1) Patients with neurological symptoms and >50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and >80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND (2) Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.

    FDA Recall
    Terminated ·Abbott Vascular·Product code NIM·September 10, 2010

    RX ACCULINK Carotid Stent System 7-10 X 40mm, Part Number: 1011344-40, Lot Number: 0072061 The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. (1) Patients with neurological symptoms and >50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and >80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND (2) Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.

    FDA Recall
    Terminated ·Abbott Vascular·Product code NIM·September 10, 2010

    StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.

    FDA Enforcement
    Class II ·Terminated·Abbott Vascular·February 22, 2017

    HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 1012589 018 HT CONNECT 300 CM 1012590 018 HT CONNECT FLEX 145 CM 1012591 018 HT CONNECT FLEX 195 CM 1012592 018 HT CONNECT FLEX 300 CM 1012593 018 HT CONNECT 250T 145 CM 1012594 018 HT CONNECT 250T 195 CM 1012595 018 HT CONNECT 250T 300 CM

    FDA Recall
    Terminated ·Abbott Vascular, Inc.·Product code DQX·November 25, 2013

    PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).

    FDA Recall
    Terminated ·Abbott Vascular·Product code MAV·July 3, 2018

    Abbott Vascular COPILOT Kit, COPILOT Bleedback Control Valve Part Number : 1003330. For use in cardiac diagnostic or therapeutic procedures.

    FDA Recall
    Terminated ·Abbott Vascular·Product code DTL·January 7, 2011

    Abbott Vascular ACS .035 Torque Device Part Number : 1003279. For use in cardiac diagnostic or therapeutic procedures.

    FDA Recall
    Terminated ·Abbott Vascular·Product code DQX·January 7, 2011

    VOYAGER NC Coronary Dilatation Catheter, 4.5 X 8.0 mm. The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, (2) Balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction, and (3) Balloon dilatation of a stent after implantation.

    FDA Recall
    Terminated ·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code MAF·November 5, 2008

    VOYAGER NC Coronary Dilatation Catheter, 4.5 X 12.0 mm. The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, (2) Balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction, and (3) Balloon dilatation of a stent after implantation.

    FDA Recall
    Terminated ·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code LOX·November 5, 2008

    NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, 1012449-15T, 1012450-08T, 1012450-12T, 1012450-15T, 1012451-08T, 1012451-12T, 1012451-15T, 1012452-08T, 1012452-12T, 1012452-15T, 1012453-08T, 1012453-12T

    FDA Recall
    Terminated ·Abbott Vascular·Product code LOX·March 22, 2017