Boston Scientific Corporation recalls
All Boston Scientific Corporation recalls we track from FDA, CPSC and NHTSA data. Categories: medical devices (165).
165 recalls published between October 23, 2024 and September 30, 2026. Most common issues: software (55), sterility (21), foreign material (4), laceration (2). 66 were FDA Class I, the most serious level.
- Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5 recall
- Boston Scientific Corporation StoneSmart Connect Console Contents: (1)… recall
- LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System… recall
- LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System… recall
- LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System… recall
- Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus… recall
- Boston Scientific ENROUTE Transcarotid Neuroprotection System… recall
- Suture Cinch Long 1pk recall
- OverStitch Suture Cinch, 1pk recall
- Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN:… recall
- Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions… recall
- Radial Jaw 4 Standard Capacity Biopsy Forceps with the following… recall
- Boston Scientific TheraSphere 360 Y-90 Management Platform… recall
- FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the… recall
- FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the… recall
- FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the… recall
- FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the… recall
- FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator… recall
- FARASTAR PFA Generator, Product ID M004PFCE61M460 recall
- FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401 recall
- FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator… recall
- Rapid Refill Continuous Injection System, UPN M00566001 recall
- CRE Wireguided 18-20mm 240cm recall
- CRE Wireguided 15-18mm 240cm recall
- CRE Wireguided 12-15mm 240cm recall
- CRE Wireguided 10-12mm 240cm recall
- CRE Wireguided 8-10mm 240cm recall
- CRE Wireguided 6-8mm 240cm recall
- CRE Pro Wireguided 18-20mm 240cm recall
- CRE Pro Wireguided 15-18mm 240cm recall
- CRE Pro Wireguided 12-15mm 240cm recall
- CRE Pro Wireguided 10-12mm 240cm recall
- CRE Pro Wireguided 8-10mm 240cm recall
- CRE Pro Wireguided 6-8mm 240cm recall
- Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H… recall
- Orca Single Use Air/Water and Suction Valves… recall
- LUX-Dx II Plus, Arrythmia detector and alarm, Model M312… recall
- LUX-DX II, Arrythmia detector and alarm, Model M302… recall
- Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1… recall
- Boston Scientific Pacemaker, Implantable Pulse Generator… recall
- EndoVive Safety PEG Kit recall
- *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm recall
- *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm recall
- HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm recall
- AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm recall
- AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm recall
- AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm recall
- Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F… recall
- LGX Preconnect with TENACIO Pump with InhibiZone recall
- CXR Preconnect with TENACIO Pump with InhibiZone recall
- CX Preconnect with TENACIO Pump with InhibiZone recall
- LGX Preconnect with TENACIO Pump without InhibiZone recall
- CX Preconnect with TENACIO Pump without InhibiZone recall
- TENACIO Pump without InhibiZone recall
- TENACIO Pump with InhibiZone recall
- Model Number U228, VISIONIST CRT-P EL MRI recall
- Model Number U226, VISIONIST CRT-P EL recall
- Model Number U225 VISIONIST CRT-P EL recall
- Model Number U128, VALITUDE CRT-P EL MRI recall
- Model Number U125, VALITUDE CRT-P EL recall