Boston Scientific Corporation recalls
49 recalls.
- NaviFlex LW Pusher recall (Boston Scientific Corporation)
Medical deviceClass IIReported October 21, 2026 · Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this... - Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5 recall (Boston Scientific Corporation)
Medical deviceClass IReported September 30, 2026 · Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged... - Boston Scientific Corporation StoneSmart Connect Console Contents: recall (Boston Scientific Corporation)
Medical deviceClass IIReported September 23, 2026 · A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power... - LUX-Dx recall (Boston Scientific Corporation)
Medical deviceClass IIReported September 9, 2026 · There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed... - LUX-Dx recall (Boston Scientific Corporation)
Medical deviceClass IIReported September 9, 2026 · There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed... - LUX-Dx recall (Boston Scientific Corporation)
Medical deviceClass IIReported September 9, 2026 · There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed... - Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus recall (Boston Scientific Corporation)
Medical deviceClass IReported August 26, 2026 · Potential for arterial sheath tip separation or partial tip separation during use. - Boston Scientific ENROUTE Transcarotid Neuroprotection System recall (Boston Scientific Corporation)
Medical deviceClass IReported August 26, 2026 · Potential for arterial sheath tip separation or partial tip separation during use. - Suture Cinch Long 1pk. Endoscopic tissue approximation device. recall (Boston Scientific Corporation)
Medical deviceClass IIReported August 26, 2026 · Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. - OverStitch Suture Cinch recall (Boston Scientific Corporation)
Medical deviceClass IIReported August 26, 2026 · Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. - Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial... recall (Boston Scientific Corporation)
Medical deviceClass IIReported August 12, 2026 · Potential for breach in sterile barrier of device packaging. - Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: ... recall (Boston Scientific Corporation)
Medical deviceClass IIReported August 12, 2026 · Potential for breach in sterile barrier of device packaging. - Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN:... recall (Boston Scientific Corporation)
Medical deviceClass IIReported August 12, 2026 · Potential for breach in sterile barrier of device packaging. - Boston Scientific TheraSphere 360 Y-90 Management Platform recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 29, 2026 · 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... - FARADRIVE STEERABLE SHEATH CLEAR OUS recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 29, 2026 · Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to... - FARADRIVE STEERABLE SHEATH recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 29, 2026 · Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to... - FARADRIVE STEERABLE SHEATH CLEAR recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 29, 2026 · Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to... - FARADRIVE Steerable Sheath Clear IDE recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 29, 2026 · Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to... - FARASTAR Ablation Generator EU recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 29, 2026 · Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter. - FARASTAR PFA Generator recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 29, 2026 · Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. - FARASTAR Pulsed Field Ablation Generator recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 29, 2026 · Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. - FARASTAR Ablation Generator EU recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 29, 2026 · Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. - Rapid Refill Continuous Injection System recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 22, 2026 · Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the... - CRE Wireguided 18-20mm 240cm recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 8, 2026 · Potential sterile breach of the pouches in which devices are packaged. - CRE Wireguided 15-18mm 240cm recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 8, 2026 · Potential sterile breach of the pouches in which devices are packaged. - CRE Wireguided 12-15mm 240cm recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 8, 2026 · Potential sterile breach of the pouches in which devices are packaged. - CRE Wireguided 10-12mm 240cm recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 8, 2026 · Potential sterile breach of the pouches in which devices are packaged. - CRE Wireguided 8-10mm 240cm recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 8, 2026 · Potential sterile breach of the pouches in which devices are packaged. - CRE Wireguided 6-8mm 240cm recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 8, 2026 · Potential sterile breach of the pouches in which devices are packaged. - CRE Pro Wireguided 18-20mm 240cm recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 8, 2026 · Potential sterile breach of the pouches in which devices are packaged. - CRE Pro Wireguided 15-18mm 240cm recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 8, 2026 · Potential sterile breach of the pouches in which devices are packaged. - CRE Pro Wireguided 12-15mm 240cm recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 8, 2026 · Potential sterile breach of the pouches in which devices are packaged. - CRE Pro Wireguided 10-12mm 240cm recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 8, 2026 · Potential sterile breach of the pouches in which devices are packaged. - CRE Pro Wireguided 8-10mm 240cm recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 8, 2026 · Potential sterile breach of the pouches in which devices are packaged. - CRE Pro Wireguided 6-8mm 240cm recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 8, 2026 · Potential sterile breach of the pouches in which devices are packaged. - Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump recall (Boston Scientific Corporation)
Medical deviceClass IIReported July 1, 2026 · There is the potential for leakage along the drug pathway from the pump through the end of the catheter. - Orca Single Use Air/Water and Suction Valves recall (Boston Scientific Corporation)
Medical deviceClass IIReported June 17, 2026 · 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... - LUX-Dx II Plus recall (Boston Scientific Corporation)
Medical deviceClass IIReported May 13, 2026 · 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... - LUX-DX II recall (Boston Scientific Corporation)
Medical deviceClass IIReported May 13, 2026 · 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... - Boston Scientific Cardiac Resynchronization Therapy recall (Boston Scientific Corporation)
Medical deviceClass IReported May 6, 2026 · Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy... - Boston Scientific Pacemaker recall (Boston Scientific Corporation)
Medical deviceClass IReported May 6, 2026 · Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy... - EndoVive Safety PEG Kit recall (Boston Scientific Corporation)
Medical deviceClass IIReported March 18, 2026 · Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of... - *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm recall (Boston Scientific Corporation)
Medical deviceClass IReported February 11, 2026 · Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is... - *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm recall (Boston Scientific Corporation)
Medical deviceClass IReported February 11, 2026 · Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is... - HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm recall (Boston Scientific Corporation)
Medical deviceClass IReported February 11, 2026 · Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is... - AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm recall (Boston Scientific Corporation)
Medical deviceClass IReported February 11, 2026 · Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is... - AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm recall (Boston Scientific Corporation)
Medical deviceClass IReported February 11, 2026 · Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is... - AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm recall (Boston Scientific Corporation)
Medical deviceClass IReported February 11, 2026 · Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is... - Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter recall (Boston Scientific Corporation)
Medical deviceClass IIReported January 21, 2026 · Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation...