Every recall we track for Boston Scientific Corporation — 567 in all — plus the complaints and injury reports the public filed about them.
Boston Scientific recalls Suture Cinch Long 1pk endoscopic tissue approximation devices that may fail to deploy the cinch implant or cut sutures as intended. Affected units have specific lot numbers and expiration dates.
Boston Scientific recalls OverStitch Suture Cinch devices that may fail to deploy the cinch implant or cut suture as intended. Affected units have specific lot numbers and expiration dates.
Boston Scientific recalls ENROUTE Transcarotid Neuroprotection System (Material Number SR-200-NPS) due to potential arterial sheath tip separation during use. Affected units include specific lot numbers and GTIN.
Boston Scientific recalls ENROUTE Transcarotid Neuroprotection System Plus (Material Number SR-250-NPS) due to potential arterial sheath tip separation during use. Affected units include specific lot numbers and GTIN.
Boston Scientific recalls Radial Jaw 4 Standard Capacity Biopsy Forceps with specific packaging that may breach sterile barriers. Affected units include certain box sizes and lot numbers. Consumers should contact the company for details.
Boston Scientific recalls Radial Jaw 4 Large Capacity Biopsy Forceps with potential packaging breaches that could compromise sterility during medical procedures. Affected units include specific box sizes and lot numbers.
Boston Scientific recalls Radial Jaw 4 Jumbo Biopsy Forceps with potential sterile packaging breaches. Affected units include specific UPNs and lot numbers. Consumers should check packaging details to determine if their device is recalled.
Boston Scientific recalls Rapid Refill Continuous Injection System (UPN M00566001) due to risk of syringe loosening or disconnecting from the manifold, potentially causing fluid leakage or procedure delays.
Boston Scientific recalls TheraSphere 360 Y-90 Management Platform software versions with a calculation error when modifying inputs after adding vials to cart. Affected units may need correction.
Boston Scientific recalls FARADRIVE Steerable Sheath (Clear) due to potential valve damage causing air embolism. Affected units have specific lot numbers; users should check if their device matches the recall list.
Boston Scientific recalls FARADRIVE Steerable Sheath Clear IDE devices due to potential air embolism from hemostatic valve damage during improper insertion. Affected units have specific material and lot numbers.
Boston Scientific recalls FARADRIVE Steerable Sheaths with specific lot numbers due to potential hemostatic valve damage causing air embolism. Affected units may need reinsertion checks to prevent patient harm.
Boston Scientific recalls FARASTAR PFA Generator (Product ID M004PFCE61M460) due to missing FARAPOINT PFA catheter information in instructions. Affected units have specific serial numbers and GTIN.
Boston Scientific recalls FARASTAR Pulsed Field Ablation Generator with labeling discrepancy affecting FARAPOINT PFA catheter use. No immediate action needed but check product details.
Boston Scientific recalls FARASTAR Ablation Generator EU models due to missing FARAPOINT PFA catheter instructions in product packaging. Consumers should check serial numbers listed in the recall notice.
Boston Scientific recalls FARASTAR PFA generators with Product ID 61M401 that may not work with FARAPOINT catheters. Affected units include specific serial numbers and model.
Boston Scientific recalls FARADRIVE Steerable Sheath Clear devices with specific lot numbers due to potential hemostatic valve damage causing air embolism. Affected patients should consult their physician.
Boston Scientific recalls CRE Pro Wireguided 18-20mm 240cm catheters due to potential sterile pouch breaches in packaging. Affected units have specific lot numbers and expiration dates.
Boston Scientific recalls CRE Wireguided 10-12mm 240cm devices with potential sterile pouch breaches. Affected units have specific lot numbers and expiration dates. Consumers should contact the company for details.
Boston Scientific recalls CRE Pro Wireguided 8-10mm 240cm devices with potential sterile breach in packaging. Affected units have specific lot numbers and expiration dates. Consumers should check their product details to determine if they are affected.
Boston Scientific recalls CRE Wireguided 18-20mm 240cm devices with potential sterile pouch breaches. Affected units have specific lot numbers and expiration dates. Consumers should contact the company for details.
Boston Scientific recalls CRE Wireguided 6-8mm 240cm devices with potential sterile pouch breaches. Affected units have specific lot numbers and expiration dates. Consumers should check their product details to determine if they are affected.
Boston Scientific recalls CRE Wireguided 15-18mm 240cm catheters with potential sterile pouch breaches. Affected units have specific lot numbers and expiration dates. Consumers should contact the company for details.
Boston Scientific recalls CRE Wireguided 12-15mm 240cm devices with potential sterile pouch breaches. Affected units have specific lot numbers and expiration dates. Consumers should contact the company for details.
Boston Scientific recalls CRE Wireguided 8-10mm 240cm devices with potential sterile pouch breaches. Affected units have specific lot numbers and expiration dates. Consumers should contact the company for details.
Boston Scientific recalls CRE Pro Wireguided 6-8mm 240cm catheters due to potential sterile pouch breaches in packaging. Affected units have specific lot numbers and expiration dates.
Boston Scientific recalls CRE Pro Wireguided 15-18mm 240cm devices with potential sterile pouch breaches. Affected units have specific lot numbers and expiration dates. Consumers should contact the company for details.
Boston Scientific recalls CRE Pro Wireguided 10-12mm 240cm catheters due to potential sterile breach in packaging. Affected units have specific lot numbers and expiration dates. Consumers should check their packaging for the lot numbers listed.
Boston Scientific recalls CRE Pro Wireguided 12-15mm 240cm catheters due to potential sterile breach in packaging. Affected units have specific lot numbers and expiration dates. Consumers should check their product details and contact the company for guidance.
Boston Scientific recalls Orca Single Use Air/Water and Suction Valves (UPN SUV-617-50) due to suction button sticking during endoscopic procedures. Affected units have GTIN 00840253111012 and lot 38400303.
Boston Scientific recalls Intera 3000 Hepatic Artery Infusion Pump AP-0300H due to potential drug leakage from the pump through the catheter. Affected units have specific serial numbers and GTIN.
Boston Scientific recalls LUX-Dx II Plus arrhythmia monitors with specific software versions that may not correctly track heart rhythm issues, requiring patient monitoring adjustments.
Boston Scientific recalls LUX-DX II arrhythmia detectors with specific software versions that may not monitor heart rhythms properly, risking missed health alerts.
Boston Scientific recalls specific pacemaker models with updated software maintenance release 6 (SMR6) for improved safety. Affected devices include ACCOLADE and ESSENTIO series pacemakers with certain model numbers and use-by dates.
Boston Scientific recalls specific CRT-P pacemakers with outdated software. Updated software (SMR6) is available to prevent potential risks in heart conditions. Affected devices include VALITUDE and VISIONIST models with certain model numbers.
Recall of Boston Scientific EndoVive Safety PEG Kits with specific box numbers due to potential loss of sterility from compromised swabstick packaging.
Boston Scientific recalls AXIOS 8mm x 8mm stent systems with material number M00553690 due to deployment problems that may require additional procedures. Affected units include specific lot numbers.
Boston Scientific recalls HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm (UPN M00553530) due to increased stent deployment and expansion problems that may require additional procedures.
Boston Scientific recalls AXIOS Stent and Electrocautery-Enhanced Delivery System (6mm x 8mm) due to deployment issues that may require additional procedures. Affected units have specific material numbers and lot numbers.
Boston Scientific recalls HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm (UPN M00553560) due to increased reports of stent deployment and expansion problems.
Boston Scientific recalls AXIOS Stent and Electrocautery-Enhanced Delivery System (20mm x 10mm) due to increased reports of deployment and expansion issues. The recall may require additional procedures to remove the stent if deployment fails.
Boston Scientific recalls HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm (UPN M00553520) due to increased deployment and expansion issues. The recall may require additional procedures to remove the stent and close the puncture site.
Boston Scientific recalls specific batches of Coyote Over-the-Wire PTA Balloon Dilation Catheters due to potential inflation/deflation difficulties during peripheral vascular procedures. Affected units were manufactured between September 12 and October 13, 2025.
Boston Scientific Corporation - 1100490724
Recalled Boston Scientific LGX Preconnect with TENACIO Pump with InhibiZone devices may experience inflation and deflation performance issues. Affected units have specific UPNs and lot numbers listed in the recall notice.
Boston Scientific recalls CX Preconnect pumps without InhibiZone due to potential inflation and deflation problems. Affected units have specific UPNs and lot numbers. Contact for replacement.
Boston Scientific recalls CXR Preconnect with TENACIO Pump with InhibiZone devices that may experience inflation or deflation performance issues. Affected units include specific UPNs and lot numbers listed in the recall notice.
Boston Scientific recalls LGX Preconnect pumps without InhibiZone due to potential inflation and deflation problems. Affected units have specific UPNs and lot numbers. Contact for remedy.
Boston Scientific recalls TENACIO Pump with InhibiZone devices with specific lot numbers due to potential inflation and deflation performance issues. Affected units may experience difficulties in function.
Boston Scientific recalls TENACIO Pumps without InhibiZone due to potential inflation and deflation performance issues. Affected units have specific lot numbers and were sold in the U.S. Learn what to do.
Boston Scientific recalls two models of Extractor Pro RX Retrieval Balloon Catheter due to incorrect labeling of the skive hole position. This could lead to improper use during medical procedures.
Boston Scientific is a global leader in medical devices, providing innovative solutions for cardiovascular, neurovascular, and other medical specialties.
Boston Scientific recalls specific ALTRUA 2 DR EL pacemakers due to potential safety software issues. Affected models include certain serial numbers and GTINs. No action is required for safe use.
Boston Scientific recalls Proponent DR SL (Model L201) pacemakers with software that may prevent safety mode activation during high battery impedance states. Affected units have specific serial numbers and GTINs. No action is required as the software update is already available.
Boston Scientific is a global leader in medical devices, providing innovative solutions for cardiovascular, neurovascular, and other medical procedures.
Boston Scientific is a leading global medical device company that develops, manufactures, and distributes innovative medical devices for the treatment of cardiovascular, cerebrovascular, and other diseases.
Boston Scientific is a global leader in medical devices, providing innovative solutions for cardiovascular, neurovascular, and other medical specialties.
Boston Scientific is a leading global medical device company that develops, manufactures, and distributes innovative medical devices and solutions for healthcare professionals.
Boston Scientific is a global leader in medical devices, providing innovative solutions for cardiovascular, neurovascular, and other medical procedures.
Boston Scientific is a leading global medical device company that develops and manufactures innovative medical devices for the treatment of cardiovascular, neurological, and other medical conditions.
