Boston Scientific Corporation

Frequent Recalls
29
Recalls
0
Units Recalled
0
Injuries
0
Deaths

Categories: Medical Device

2026-03-18 to 2026-07-29

DateSourceProductBrandSeverityUnits
2026-07-29FDA DeviceFDA Recall: FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the cBoston Scientific CorporationClass IIN/A
2026-07-29FDA DeviceFDA Recall: FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation CatheterBoston Scientific CorporationClass IIN/A
2026-07-29FDA DeviceFDA Recall: FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chamBoston Scientific CorporationClass IIN/A
2026-07-29FDA DeviceFDA Recall: FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chamBoston Scientific CorporationClass IIN/A
2026-07-29FDA DeviceFDA Recall: FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous CarBoston Scientific CorporationClass IIN/A
2026-07-29FDA DeviceFDA Recall: Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Boston Scientific CorporationClass IIN/A
2026-07-29FDA DeviceFDA Recall: FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambersBoston Scientific CorporationClass IIN/A
2026-07-29FDA DeviceFDA Recall: FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous CarBoston Scientific CorporationClass IIN/A
2026-07-29FDA DeviceFDA Recall: FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation CBoston Scientific CorporationClass IIN/A
2026-07-22FDA DeviceFDA Recall: Rapid Refill Continuous Injection System, UPN M00566001Boston Scientific CorporationClass IIN/A
2026-07-08FDA DeviceFDA Recall: CRE Wireguided 10-12mm 240cmBoston Scientific CorporationClass IIN/A
2026-07-08FDA DeviceFDA Recall: CRE Wireguided 18-20mm 240cmBoston Scientific CorporationClass IIN/A
2026-07-08FDA DeviceFDA Recall: CRE Pro Wireguided 12-15mm 240cmBoston Scientific CorporationClass IIN/A
2026-07-08FDA DeviceFDA Recall: CRE Pro Wireguided 10-12mm 240cmBoston Scientific CorporationClass IIN/A
2026-07-08FDA DeviceFDA Recall: CRE Pro Wireguided 15-18mm 240cmBoston Scientific CorporationClass IIN/A
2026-07-08FDA DeviceFDA Recall: CRE Wireguided 6-8mm 240cmBoston Scientific CorporationClass IIN/A
2026-07-08FDA DeviceFDA Recall: CRE Pro Wireguided 8-10mm 240cmBoston Scientific CorporationClass IIN/A
2026-07-08FDA DeviceFDA Recall: CRE Pro Wireguided 18-20mm 240cmBoston Scientific CorporationClass IIN/A
2026-07-08FDA DeviceFDA Recall: CRE Pro Wireguided 6-8mm 240cmBoston Scientific CorporationClass IIN/A
2026-07-08FDA DeviceFDA Recall: CRE Wireguided 8-10mm 240cmBoston Scientific CorporationClass IIN/A
2026-07-08FDA DeviceFDA Recall: CRE Wireguided 12-15mm 240cmBoston Scientific CorporationClass IIN/A
2026-07-08FDA DeviceFDA Recall: CRE Wireguided 15-18mm 240cmBoston Scientific CorporationClass IIN/A
2026-07-01FDA DeviceFDA Recall: Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery deviceBoston Scientific CorporationClass IIN/A
2026-06-17FDA DeviceFDA Recall: Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water VBoston Scientific CorporationClass IIN/A
2026-05-13FDA DeviceFDA Recall: LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe)Boston Scientific CorporationClass IIN/A
2026-05-13FDA DeviceFDA Recall: LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Boston Scientific CorporationClass IIN/A
2026-05-06FDA DeviceFDA Recall: Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Boston Scientific CorporationClass IN/A
2026-05-06FDA DeviceFDA Recall: Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-SynchronizationBoston Scientific CorporationClass IN/A
2026-03-18FDA DeviceFDA Recall: EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPBoston Scientific CorporationClass IIN/A
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