← All recallsAll Boston Scientific Corporation Recalls
Medical Device2026-07-29
FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M0Medical Device2026-07-29
FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C60Medical Device2026-07-29
FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PMedical Device2026-07-29
Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.Medical Device2026-07-29
FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation CatheterMedical Device2026-07-29
FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation CatheterMedical Device2026-07-29
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation CatheterMedical Device2026-07-29
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation CatheterMedical Device2026-07-29
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IMedical Device2026-07-22
Rapid Refill Continuous Injection System, UPN M00566001Medical Device2026-07-08
CRE Pro Wireguided 18-20mm 240cmMedical Device2026-07-08
CRE Wireguided 10-12mm 240cmMedical Device2026-07-08
CRE Pro Wireguided 8-10mm 240cmMedical Device2026-07-08
CRE Wireguided 18-20mm 240cmMedical Device2026-07-08
CRE Wireguided 6-8mm 240cmMedical Device2026-07-08
CRE Wireguided 15-18mm 240cmMedical Device2026-07-08
CRE Wireguided 12-15mm 240cmMedical Device2026-07-08
CRE Wireguided 8-10mm 240cmMedical Device2026-07-08
CRE Pro Wireguided 6-8mm 240cmMedical Device2026-07-08
CRE Pro Wireguided 15-18mm 240cmMedical Device2026-07-08
CRE Pro Wireguided 10-12mm 240cmMedical Device2026-07-08
CRE Pro Wireguided 12-15mm 240cmMedical Device2026-07-01
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery deviceMedical Device2026-06-17
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 tMedical Device2026-05-13
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 Medical Device2026-05-13
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5Medical Device2026-05-06
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR Medical Device2026-05-06
Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI,Medical Device2026-03-18
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000;Medical Device2026-02-11
AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;Medical Device2026-02-11
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;Medical Device2026-02-11
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;Medical Device2026-02-11
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;Medical Device2026-02-11
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;Medical Device2026-02-11
HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;