BEUDAMED
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    Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Manufactured by Greathbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441. To facilitate transvenous introduction of diagnostic / therapeutic catheters into the vasculature and into the chambers of the heart.

    FDA Enforcement
    Class II ·Terminated·Greatbatch Medical·October 3, 2012

    Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number: ATS 2-5. Product is manufactured and distributed by Boston Scientific Corporation (BSC), Sunnyvale, CA The Alair Bronchial Thermoplasty System (including the Alair Bronchial Thermoplasty Catheter) is indicated for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·July 24, 2013

    RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.

    FDA Enforcement
    Class III ·Terminated·Boston Scientific Corporation·July 17, 2013

    Boston Scientific brand Renegade Fiber Braided Microcatheter, 150/10/2RO, Rx Only; Model Numbers: 18257, 18259; Product is distributed by Boston Scientific Corporation, Natick, MA; Product is manufactured by Boston Scientific Corporation, Cork, Ireland

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KRA·August 24, 2009

    Boston Scientific brand Neuro Renegade Hi-Flo Microcatheter, 150cm/20cm; Rx Only; Model Numbers: 182880US, 182890US, 182900US, 182910US; Product is distributed by Boston Scientific Corporation, Natick, MA; Product is manufactured by Boston Scientific Corporation, Cork, Ireland

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KRA·August 24, 2009

    Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product Number: M003450200, Product is manufactured by Boston Scientific Corporation, Fremont, CA and distributed by Stryker Neurovascular, Fremont, CA The Neuroform Microdelivery Stent System is intended for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of greater than equal to 2 mm and greater than equal to 4.5 mm that are not amenable to treatment with surgical clipping.

    FDA Enforcement
    Class II ·Terminated·Stryker Neurovascular·July 31, 2013

    Boston Scientific SteeroCath-Dx Diagnostic Catheter, Manufactured by Boston Scientific Corporation, San Jose, CA - Cardiac Catheter

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code DRF·February 14, 2008

    Guider XF Softip Guide Catheter, manufactured by Boston Scientific Corporation, Maple Grove, MN, distributed by Boston Scientific Corporation, Fremont, CA. The device is intended to facilitate placement of interventional devices into the neurovascular system.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQY·October 6, 2009

    Boston Scientific Peristaltic Tubing Kit, Model 2104, UPN M0043521040. For use with Boston Scientific CHILLI Cooled Ablation Catheters and Model 8005 Continuous Operation Pump. Sterilized using Ethylene Oxide. Contents: peristaltic pump fluid delivery extension tube set. Manufactured for: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA. Tubing Set (model 2104) for use with Boston Scientific Cooled Ablation System.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LPB·September 27, 2010

    Boston Scientific iLab Ultrasound Imaging System, models 120INS and 240INS. Its intended use is for ultrasound examination of intravascular pathology. Manufactured by Boston Scientific Corporation, Fremont, CA.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code IYO·September 5, 2008

    Silicone Central Venous Catheter with PASV Valve and Polyester Cuff - 6.6F. Boston Scientific Cat. #CVC661IK M001CVC661IK0. Firm on label: Boston Scientific Corporation, NAMIC Technology Center, Glens Falls, NY 12801.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code LJS·October 28, 2005

    Boston Scientific IQ Guide Wire. Catalog No. 38950-01J0, 185 cm, J-Tip, Single Pack. Sterile EO. Manufactured for: Boston Scientific Corporation, One Boston Scientific Place, Natick, MN 01760 USA. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip.

    FDA Recall
    Terminated ·Boston Scientific·Product code DQX·May 30, 2006

    Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Standard; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distributed by Boston Scientific Corporation, Fremont, CA The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQX·June 7, 2010

    Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Standard Pre-Shaped; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distributed by Boston Scientific Corporation, Fremont, CA The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQX·June 7, 2010

    Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Standard Pre-Shaped; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distributed by Boston Scientific Corporation, Fremont, CA The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQX·June 7, 2010

    Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Standard; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distributed by Boston Scientific Corporation, Fremont, CA The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQX·June 7, 2010

    Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 35 cm tip; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distributed by Boston Scientific Corporation, Fremont, CA The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQX·June 7, 2010

    Boston Scientific brand Synchro.14" Guide Wire, 35 cm, tip; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distributed by Boston Scientific Corporation, Fremont, CA The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQX·June 7, 2010

    Boston Scientific brand Synchro.14" Guide Wire, 200 cm length, 35 cm tip; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distributed by Boston Scientific Corporation, Fremont, CA The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQX·June 7, 2010

    Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Soft Pre Shaped; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distributed by Boston Scientific Corporation, Fremont, CA The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DQX·June 7, 2010