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

    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 Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm UPN: M00536730

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·December 4, 2019

    Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·February 27, 2019

    StarMedTec LightTrail¿ Reusable Fibers, 600 um; Material/Part Number: 6455

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·October 15, 2014

    ACCOLADE Pacemaker

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·October 3, 2018

    Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. These pulse generators provide bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·September 14, 2016

    TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Universal Product Number (UPN):M00561412. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·January 22, 2014

    TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses. Universal Product Number (UPN):M00561422 Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·January 22, 2014

    TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN):M00561420. Distributed by: Boston Scientific, Natick, MA. Manufactured by: Horizons International Corp., Costa Rica Intended to be used in flexible endoscopes as a retrieval device for foreign body objects, such as polyps and food boluses.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·January 22, 2014

    Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·October 3, 2018

    ESSENTIO Pacemaker

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·October 3, 2018

    VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·October 3, 2018

    Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV270, Catalog Number LTV27; Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or AVA index of <0.6 em /m2) who are at extreme or high risk for standard surgical valve replacement.

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·January 21, 2015

    Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000 The Extractor Pro RX Retrieval Balloon Catheters are intended for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·July 8, 2015

    AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R 105650-004H 105650-004R 105650-007R 105650-009R 105650-024H 105650-024Z 105650-025 105650-025H 105650-025R 105650-026R Product Usage - The AngioJet allows for percutaneous removal of thrombus located in peripheral arteries and veins, saphenous vein bypass grafts, native coronary arteries, and native or synthetic AV access conduits. Thrombectomy is accomplished using high-pressure saline jets contained in the catheter shaft. The saline jets create a low-pressure effect to draw thrombus into the catheter, fragment the thrombus, and remove the thrombus from the treatment site. The system consists of a single use Thrombectomy Set (several models available) and a free standing mobile Console.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·December 25, 2019

    VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·October 3, 2018

    PROPONENT Pacemaker

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·October 3, 2018