Countries where the notices were issued: United States (92).
Name as written in the notices: Boston Scientific Corporation. This is the brand or the responsible company as each authority recorded it. A recall shows a safety system working; it is not a verdict on a brand. Follow the official notice for each product.
| Date | Authority | Product | Hazard (as classified) |
|---|
| 2026-08-06 | US FDA — Medical Devices | LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Ver | — |
| 2026-08-06 | US FDA — Medical Devices | LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Ve | — |
| 2026-08-06 | US FDA — Medical Devices | LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Ver | — |
| 2026-06-30 | US FDA — Medical Devices | Rapid Refill Continuous Injection System, UPN M00566001 | — |
| 2026-06-19 | US FDA — Medical Devices | Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing Sys | — |
| 2026-06-11 | US FDA — Medical Devices | FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Mater | — |
| 2026-06-11 | US FDA — Medical Devices | FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, M | — |
| 2026-06-11 | US FDA — Medical Devices | FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, M | — |
| 2026-06-11 | US FDA — Medical Devices | FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart | — |
| 2026-03-30 | US FDA — Medical Devices | LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5 | — |
| 2026-03-30 | US FDA — Medical Devices | LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Versio | — |
| 2026-03-19 | US FDA — Medical Devices | Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VA | — |
| 2026-03-19 | US FDA — Medical Devices | Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as | — |
| 2025-12-19 | US FDA — Medical Devices | HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520; | — |
| 2025-12-19 | US FDA — Medical Devices | AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660; | — |
| 2025-12-19 | US FDA — Medical Devices | *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560; | — |
| 2025-12-19 | US FDA — Medical Devices | AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680; | — |
| 2025-08-20 | US FDA — Medical Devices | Model Number L211 PROPONENT DR SL MRI Pacemaker | — |
| 2025-08-20 | US FDA — Medical Devices | Model Number S702, ALTRUA 2 DR SL Pacemaker | — |
| 2025-08-20 | US FDA — Medical Devices | Model Number U128, VALITUDE CRT-P EL MRI | — |
| 2025-08-20 | US FDA — Medical Devices | Model Number L231, PROPONENT DR EL MRI Pacemaker | — |
| 2025-08-20 | US FDA — Medical Devices | Model Number L101, ESSENTIO DR SL Pacemaker | — |
| 2025-08-20 | US FDA — Medical Devices | Model Number L209 PROPONENT DR (VDD) SL Pacemaker | — |
| 2025-08-20 | US FDA — Medical Devices | Model Number U226, VISIONIST CRT-P EL | — |
| 2025-08-20 | US FDA — Medical Devices | PROPONENT SR SL (Model L200) | — |
| 2025-08-20 | US FDA — Medical Devices | Model Number U228, VISIONIST CRT-P EL MRI | — |
| 2025-08-20 | US FDA — Medical Devices | Model Number L221 PROPONENT DR EL Pacemaker | — |
| 2025-08-20 | US FDA — Medical Devices | Model Number L131, ESSENTIO DR EL MRI Pacemaker | — |
| 2025-08-20 | US FDA — Medical Devices | ACCOLADE DR EL MRI (Model L331) | — |
| 2025-08-20 | US FDA — Medical Devices | Model Number L121 ESSENTIO DR EL Pacemaker | — |
| 2025-08-05 | US FDA — Medical Devices | Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology) | — |
| 2025-08-05 | US FDA — Medical Devices | Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. | — |
| 2025-07-29 | US FDA — Medical Devices | WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal | — |
| 2025-07-29 | US FDA — Medical Devices | WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transsepta | — |
| 2025-07-29 | US FDA — Medical Devices | WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal | — |
| 2025-07-29 | US FDA — Medical Devices | WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal | — |
| 2025-07-29 | US FDA — Medical Devices | WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal | — |
| 2025-07-29 | US FDA — Medical Devices | WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal | — |
| 2025-06-10 | US FDA — Medical Devices | Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F | — |
| 2025-06-10 | US FDA — Medical Devices | VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (18 | — |
| 2025-06-10 | US FDA — Medical Devices | VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Devic | — |
| 2025-06-10 | US FDA — Medical Devices | VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACRO | — |
| 2025-03-24 | US FDA — Medical Devices | IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure | — |
| 2025-03-24 | US FDA — Medical Devices | IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure g | — |
| 2025-03-24 | US FDA — Medical Devices | IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure | — |
| 2024-09-05 | US FDA — Medical Devices | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes a | — |
| 2024-09-05 | US FDA — Medical Devices | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN; the system utilizes an | — |
| 2024-09-05 | US FDA — Medical Devices | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an interactive | — |
| 2024-09-05 | US FDA — Medical Devices | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive dis | — |
| 2024-09-05 | US FDA — Medical Devices | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US; the system utilizes an int | — |
| 2024-09-05 | US FDA — Medical Devices | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an interacti | — |
| 2024-09-05 | US FDA — Medical Devices | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes a | — |
| 2024-09-05 | US FDA — Medical Devices | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an | — |
| 2024-09-05 | US FDA — Medical Devices | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPGRADE JP; the system utilizes an | — |
| 2024-09-05 | US FDA — Medical Devices | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; the system utilizes an | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H74908526512; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF H749085263011; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265002; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085261002; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H749085263001; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H749085261802; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085261952; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H749085263022; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982; cardiac catheter | — |
| 2024-03-21 | US FDA — Medical Devices | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012; cardiac catheter | — |
| 2024-02-20 | US FDA — Medical Devices | EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both ped | — |
| 2024-02-20 | US FDA — Medical Devices | Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010 | — |
| 2024-02-20 | US FDA — Medical Devices | EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pe | — |
| 2024-02-20 | US FDA — Medical Devices | EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pedi | — |