Boston Scientific Corporation

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

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

Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure.

FDA Enforcement

Class II ·Ongoing·Boston Scientific Corporation·June 17, 2026

LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5

FDA Enforcement

Class II ·Ongoing·Boston Scientific Corporation·May 13, 2026

LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5

FDA Enforcement

Class II ·Ongoing·Boston Scientific Corporation·May 13, 2026

EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;

FDA Enforcement

Class II ·Ongoing·Boston Scientific Corporation·March 18, 2026

Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; Catheter, Angioplasty, Peripheral, Transluminal

FDA Enforcement

Class II ·Ongoing·Boston Scientific Corporation·January 21, 2026

TENACIO Pump with InhibiZone; UPN: 72404429;

FDA Enforcement

Class II ·Ongoing·Boston Scientific Corporation·October 22, 2025

LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);

FDA Enforcement

Class II ·Ongoing·Boston Scientific Corporation·October 22, 2025

Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventional Cardiology and Peripheral Interventions)

FDA Enforcement

Class II ·Ongoing·Boston Scientific Corporation·September 17, 2025

CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 72404432 (18CM PS IZ), (4) 72404433 (21CM PS IZ), (5) 72404434 (24CM PS IZ), (6) 72404435 (12CM IP IZ), (7) 72404436 (15CM IP IZ), (8) 72404437 (18CM IP IZ), (9) 72404438 (21CM IP IZ), (10) 72404439 (24CM IP IZ);

FDA Enforcement

Class II ·Ongoing·Boston Scientific Corporation·October 22, 2025

Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);

FDA Enforcement

Class II ·Ongoing·Boston Scientific Corporation·October 1, 2025

Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. M0062251230, 5. M0062251240, 6. M0062251260, 7. M0062251290, 8. M0062251300, 9. M0062251310. 10. M0062251350, 11. M0062251360, 12. M0062251370. (Urology)

FDA Enforcement

Class II ·Ongoing·Boston Scientific Corporation·September 17, 2025

Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)

FDA Enforcement

Class II ·Ongoing·Boston Scientific Corporation·September 17, 2025

TENACIO Pump without InhibiZone; UPN: 72404420;

FDA Enforcement

Class II ·Ongoing·Boston Scientific Corporation·October 22, 2025

Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M0067101140; 4. M001151050; 5. M001151062; 6. M00566670. (Interventional Cardiology, Peripheral Interventions)

FDA Enforcement

Class II ·Ongoing·Boston Scientific Corporation·September 17, 2025

CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6) 72404466 (12CM IP IZ), (7) 72404467 (14CM IP IZ), (8) 72404468 (16CM IP IZ), (9) 72404469 (18CM IP IZ);

FDA Enforcement

Class II ·Ongoing·Boston Scientific Corporation·October 22, 2025

VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized in Japan only.

FDA Enforcement

Class II ·Ongoing·Boston Scientific Corporation·July 16, 2025

FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401

FDA Enforcement

Class II ·Ongoing·Boston Scientific Corporation·August 20, 2025