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Boston Scientific Recalls
651 recalls on record · June 27, 2012 to August 12, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 12, 2026Medical DevicesFDA
Boston Scientific Corporation recalls Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer
Hazard: Potential for breach in sterile barrier of device packaging.
August 12, 2026Medical DevicesFDA
Boston Scientific Corporation recalls Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20
Hazard: Potential for breach in sterile barrier of device packaging.
August 12, 2026Medical DevicesFDA
Boston Scientific Corporation recalls Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box
Hazard: Potential for breach in sterile barrier of device packaging.
July 29, 2026Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing Sys
Hazard: Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose calculation is updated correctly; however, any vials that were previously added to the cart are not automatically updated to reflect the revised calculation.
July 29, 2026Medical DevicesFDA
Boston Scientific Corporation recalls FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, M
Hazard: Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
July 29, 2026Medical DevicesFDA
Boston Scientific Corporation recalls FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart
Hazard: Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
July 29, 2026Medical DevicesFDA
Boston Scientific Corporation recalls FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Mater
Hazard: Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
July 29, 2026Medical DevicesFDA
Boston Scientific Corporation recalls FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, M
Hazard: Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
July 29, 2026Medical DevicesFDA
Boston Scientific Corporation recalls FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Cathet
Hazard: Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
July 29, 2026Medical DevicesFDA
Boston Scientific Corporation recalls FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
Hazard: Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
July 29, 2026Medical DevicesFDA
Boston Scientific Corporation recalls FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
Hazard: Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
July 29, 2026Medical DevicesFDA
Boston Scientific Corporation recalls FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Cathet
Hazard: Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
July 22, 2026Medical DevicesFDA
Boston Scientific Corporation recalls Rapid Refill Continuous Injection System, UPN M00566001
Hazard: Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.
July 8, 2026Medical DevicesFDA
Boston Scientific Corporation recalls CRE Wireguided 18-20mm 240cm
Hazard: Potential sterile breach of the pouches in which devices are packaged.
July 8, 2026Medical DevicesFDA
Boston Scientific Corporation recalls CRE Wireguided 15-18mm 240cm
Hazard: Potential sterile breach of the pouches in which devices are packaged.
July 8, 2026Medical DevicesFDA
Boston Scientific Corporation recalls CRE Wireguided 12-15mm 240cm
Hazard: Potential sterile breach of the pouches in which devices are packaged.
July 8, 2026Medical DevicesFDA
Boston Scientific Corporation recalls CRE Wireguided 10-12mm 240cm
Hazard: Potential sterile breach of the pouches in which devices are packaged.
July 8, 2026Medical DevicesFDA
Boston Scientific Corporation recalls CRE Wireguided 8-10mm 240cm
Hazard: Potential sterile breach of the pouches in which devices are packaged.
July 8, 2026Medical DevicesFDA
Boston Scientific Corporation recalls CRE Wireguided 6-8mm 240cm
Hazard: Potential sterile breach of the pouches in which devices are packaged.
July 8, 2026Medical DevicesFDA
Boston Scientific Corporation recalls CRE Pro Wireguided 18-20mm 240cm
Hazard: Potential sterile breach of the pouches in which devices are packaged.
July 8, 2026Medical DevicesFDA
Boston Scientific Corporation recalls CRE Pro Wireguided 15-18mm 240cm
Hazard: Potential sterile breach of the pouches in which devices are packaged.
July 8, 2026Medical DevicesFDA
Boston Scientific Corporation recalls CRE Pro Wireguided 12-15mm 240cm
Hazard: Potential sterile breach of the pouches in which devices are packaged.
July 8, 2026Medical DevicesFDA
Boston Scientific Corporation recalls CRE Pro Wireguided 10-12mm 240cm
Hazard: Potential sterile breach of the pouches in which devices are packaged.
July 8, 2026Medical DevicesFDA
Boston Scientific Corporation recalls CRE Pro Wireguided 8-10mm 240cm
Hazard: Potential sterile breach of the pouches in which devices are packaged.
July 8, 2026Medical DevicesFDA
Boston Scientific Corporation recalls CRE Pro Wireguided 6-8mm 240cm
Hazard: Potential sterile breach of the pouches in which devices are packaged.
July 1, 2026Medical DevicesFDA
Boston Scientific Corporation recalls Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
Hazard: There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
June 17, 2026Medical DevicesFDA
Boston Scientific Corporation recalls Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to
Hazard: Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.
May 13, 2026Medical DevicesFDA
Boston Scientific Corporation recalls LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Versio
Hazard: For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
May 13, 2026Medical DevicesFDA
Boston Scientific Corporation recalls LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
Hazard: For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.
May 6, 2026Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VA
Hazard: Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia