Boston Scientific Corporation recalls
100 recalls filed under Boston Scientific Corporation. The most recent was published July 8, 2026.
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Class II · 4 months ago
Boston Scientific Corporation CRE Pro Wireguided 8-10mm 240cm recall: Potential sterile breach of the pouches in which devices are packaged
Potential sterile breach of the pouches in which devices are packaged.
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Class II · 4 months ago
Boston Scientific Corporation CRE Wireguided 18-20mm 240cm recall: Potential sterile breach of the pouches in which devices are packaged
Potential sterile breach of the pouches in which devices are packaged.
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Class II · 4 months ago
Boston Scientific Corporation CRE Wireguided 6-8mm 240cm recall: Potential sterile breach of the pouches in which devices are packaged
Potential sterile breach of the pouches in which devices are packaged.
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Class II · 4 months ago
Boston Scientific Corporation CRE Wireguided 15-18mm 240cm recall: Potential sterile breach of the pouches in which devices are packaged
Potential sterile breach of the pouches in which devices are packaged.
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Class II · 4 months ago
Boston Scientific Corporation CRE Wireguided 12-15mm 240cm recall: Potential sterile breach of the pouches in which devices are packaged
Potential sterile breach of the pouches in which devices are packaged.
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Class II · 4 months ago
Boston Scientific Corporation CRE Wireguided 8-10mm 240cm recall: Potential sterile breach of the pouches in which devices are packaged
Potential sterile breach of the pouches in which devices are packaged.
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Class II · 4 months ago
Boston Scientific Corporation CRE Pro Wireguided 6-8mm 240cm recall: Potential sterile breach of the pouches in which devices are packaged
Potential sterile breach of the pouches in which devices are packaged.
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Class II · 4 months ago
Boston Scientific Corporation CRE Pro Wireguided 15-18mm 240cm recall: Potential sterile breach of the pouches in which devices are packaged
Potential sterile breach of the pouches in which devices are packaged.
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Class II · 4 months ago
Boston Scientific Corporation CRE Pro Wireguided 10-12mm 240cm recall: Potential sterile breach of the pouches in which devices are packaged
Potential sterile breach of the pouches in which devices are packaged.
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Class II · 4 months ago
Boston Scientific Corporation CRE Pro Wireguided 12-15mm 240cm recall: Potential sterile breach of the pouches in which devices are packaged
Potential sterile breach of the pouches in which devices are packaged.
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Class II · 4 months ago
Boston Scientific Corporation Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recall: There is the potential for leakage along the drug pathway from the pump
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
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Class II · 4 months ago
Boston Scientific Corporation Orca Single Use Air/Water and Suction Valves recall: Boston Scientific is initiating a medical device removal of Orca Sterile
Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated…
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Class II · 6 months ago
Boston Scientific Corporation Lux-Dx II Plus, Arrythmia detector and alarm, Model M312 recall: For some patients upgraded from a LUX-Dx M301 device to a new Model M302
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…
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Class II · 6 months ago
Boston Scientific Corporation Lux-Dx II, Arrythmia detector and alarm, Model M302 recall: For some patients upgraded from a LUX-Dx M301 device to a new Model M302
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…
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Class I · 6 months ago
Boston Scientific Pacemaker, Implantable Pulse Generator recall: Updated software, Brady software maintenance release 6 (SMR6)
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization…
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Class I · 6 months ago
Boston Scientific Cardiac Resynchronization Therapy labeled as: 1 recall: Updated software, Brady software maintenance release 6 (SMR6)
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization…
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Class II · 7 months ago
Boston Scientific Corporation EndoVive Safety PEG Kit recall: Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open
Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result…
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Class I · 9 months ago
Boston Scientific Corporation AXIOS Stent and Electrocautery-Enhanced Delivery System recall: Increased reports of stent deployment and expansion issues. The most common
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the…
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Class I · 9 months ago
Boston Scientific Corporation *HOT AXIOS Stent and Electrocautery-Enhanced Delivery recall: Increased reports of stent deployment and expansion issues. The most common
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the…
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Class I · 9 months ago
Boston Scientific Corporation AXIOS Stent and Electrocautery-Enhanced Delivery System recall: Increased reports of stent deployment and expansion issues. The most common
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the…
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Class I · 9 months ago
Boston Scientific Corporation *HOT AXIOS Stent and Electrocautery-Enhanced Delivery recall: Increased reports of stent deployment and expansion issues. The most common
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the…
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Class I · 9 months ago
Boston Scientific Corporation AXIOS Stent and Electrocautery-Enhanced Delivery System recall: Increased reports of stent deployment and expansion issues. The most common
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the…
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Class I · 9 months ago
Boston Scientific Corporation HOT AXIOS Stent and Electrocautery-Enhanced Delivery recall: Increased reports of stent deployment and expansion issues. The most common
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the…
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Class II · 9 months ago
Boston Scientific Coyote Over-The-Wire PTA Balloon Dilation Catheter recall: Boston Scientific is initiating the removal of certain batches of Coyote"
Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon…
About this page
Boston Scientific Corporation appears here because a federal agency named it as the recalling firm or the brand on the label. A recall is not a judgement about everything the company sells — it covers only the lot codes and models listed in each notice.