Boston Scientific Corporation recalls
100 recalls filed under Boston Scientific Corporation. The most recent was published September 30, 2026.
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Class I · 25 days ago
Boston Scientific Corporation Imager II Angiographic Catheters M001314001 Imager recall: Tip may fracture or detach, leading to device fragments remaining within
Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include…
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Class II · last month
Boston Scientific Corporation StoneSmart Connect Console Contents recall: A subset of power adapters used with the connect console may exhibit
A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result…
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Class II · last month
Boston Scientific Corporation Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac recall: There is potential for a delay in AF Burden Alert notification affecting
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs)…
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Class II · last month
Boston Scientific Corporation Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac recall: There is potential for a delay in AF Burden Alert notification affecting
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs)…
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Class II · last month
Boston Scientific Corporation Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac recall: There is potential for a delay in AF Burden Alert notification affecting
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs)…
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Class I · 2 months ago
Boston Scientific Enroute Transcarotid Neuroprotection System recall: Potential for arterial sheath tip separation or partial tip separation during
Potential for arterial sheath tip separation or partial tip separation during use.
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Class I · 2 months ago
Boston Scientific Enroute Transcarotid Neuroprotection System Plus recall: Potential for arterial sheath tip separation or partial tip separation during
Potential for arterial sheath tip separation or partial tip separation during use.
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Class II · 2 months ago
Boston Scientific Corporation Suture Cinch Long 1pk. Endoscopic tissue approximation recall: Device may fail to deploy the cinch implant and/or fail to cut the suture
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
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Class II · 2 months ago
Boston Scientific Corporation OverStitch Suture Cinch recall: Device may fail to deploy the cinch implant and/or fail to cut the suture
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
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Class II · 2 months ago
Boston Scientific Corporation Radial Jaw 4 Standard Capacity Biopsy Forceps recall: Potential for breach in sterile barrier of device packaging
Potential for breach in sterile barrier of device packaging.
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Class II · 2 months ago
Boston Scientific Corporation Radial Jaw 4 Large Capacity Biopsy Forceps recall: Potential for breach in sterile barrier of device packaging
Potential for breach in sterile barrier of device packaging.
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Class II · 2 months ago
Boston Scientific Corporation Radial Jaw 4 Jumbo Biopsy Forceps with the following recall: Potential for breach in sterile barrier of device packaging
Potential for breach in sterile barrier of device packaging.
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Class II · 3 months ago
Boston Scientific Corporation Faradrive Steerable Sheath - US recall: Boston Scientific's complaint investigations have identified that a subset
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage…
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Class II · 3 months ago
Boston Scientific Corporation Faradrive Steerable Sheath Clear IDE recall: Boston Scientific's complaint investigations have identified that a subset
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage…
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Class II · 3 months ago
Boston Scientific Corporation Faradrive Steerable Sheath Clear OUS recall: Boston Scientific's complaint investigations have identified that a subset
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage…
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Class II · 3 months ago
Boston Scientific TheraSphere 360 Y-90 Management Platform recall: Software anomaly occurs when a user adds one or more vials to the cart
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…
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Class II · 3 months ago
Boston Scientific Corporation Farastar PFA Generator, Product ID M004Pfce61M460 recall: Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
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Class II · 3 months ago
Boston Scientific Corporation Farastar Pulsed Field Ablation Generator recall: Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
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Class II · 3 months ago
Boston Scientific Corporation Farastar Ablation Generator EU recall: Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
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Class II · 3 months ago
Boston Scientific Corporation Farastar Ablation Generator EU recall: Boston Scientific is replacing specific FARASTAR PFA generators which have
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA…
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Class II · 3 months ago
Boston Scientific Corporation Faradrive Steerable Sheath Clear recall: Boston Scientific's complaint investigations have identified that a subset
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage…
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Class II · 3 months ago
Boston Scientific Corporation Rapid Refill Continuous Injection System, UPN M00566001 recall: Devices contain recalled Medline Namic Angiographic Control Syringe
Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from…
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Class II · 4 months ago
Boston Scientific Corporation CRE Pro 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 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.
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.