Boston Scientific Corporation recalls
100 recalls filed under Boston Scientific Corporation. The most recent was published October 22, 2025.
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Class I · 1+ years ago
Boston Scientific Corporation Proponent SR SL recall: Software to enhance Safety Architecture is available and designed to prevent
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery…
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Class II · 1+ years ago
Boston Scientific Corporation Tenacio Pump with InhibiZone recall: The potential for devices to experience inflation and/or deflation
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
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Class I · 1+ years ago
Boston Scientific Corporation recall: Software to enhance Safety Architecture is available and designed to prevent
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery…
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Class I · 1+ years ago
Boston Scientific Corporation recall: Software to enhance Safety Architecture is available and designed to prevent
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery…
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Class I · 1+ years ago
Boston Scientific Corporation recall: Software to enhance Safety Architecture is available and designed to prevent
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery…
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Class II · 1+ years ago
Boston Scientific Corporation Tenacio Pump without InhibiZone recall: The potential for devices to experience inflation and/or deflation
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
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Class I · 1+ years ago
Boston Scientific Corporation recall: Software to enhance Safety Architecture is available and designed to prevent
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery…
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Class I · 1+ years ago
Boston Scientific Corporation recall: Software to enhance Safety Architecture is available and designed to prevent
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery…
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Class I · 1+ years ago
Boston Scientific Corporation recall: Software to enhance Safety Architecture is available and designed to prevent
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery…
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Class I · 1+ years ago
Boston Scientific Corporation recall: Software to enhance Safety Architecture is available and designed to prevent
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery…
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Class II · 1+ years ago
Boston Scientific Corporation Extractor Pro RX Retrieval Balloon Catheter recall: The product in incorrectly labeled. The label indicates that the skive hole
The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and…
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Class II · 1+ years ago
Boston Scientific Encore Advantage Kit, Material Numbers : 1 recall: The Encore 26 Inflation Device is used with balloon dilation catheters
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An…
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Class II · 1+ years ago
Boston Scientific Encore 26 Inflation Device recall: The Encore 26 Inflation Device is used with balloon dilation catheters
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An…
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Class II · 1+ years ago
Boston Scientific UroMax Ultra Kit, Material Numbers : 1. M0062251200 recall: The Encore 26 Inflation Device is used with balloon dilation catheters
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An…
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Class II · 1+ years ago
Boston Scientific Corporation Preventive Maintenance Kit Icefx recall: Certain desiccant tube subassemblies were built with end caps
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
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Class II · 1+ years ago
Boston Scientific Corporation ICEfx Cryoablation System recall: Certain desiccant tube subassemblies were built with end caps
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
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Class II · 1+ years ago
Boston Scientific NephroMax Kit, Material Numbers : 1. M0062101180 recall: The Encore 26 Inflation Device is used with balloon dilation catheters
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An…
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Class I · 1+ years ago
Boston Scientific Corporation Watchman TruSeal Access System ANT, OUS recall: Boston Scientific has identified a higher likelihood of air embolism events
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled…
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Class I · 1+ years ago
Boston Scientific Corporation Watchman TruSeal Access System ANT, US recall: Boston Scientific has identified a higher likelihood of air embolism events
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled…
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Class I · 1+ years ago
Boston Scientific Corporation Watchman FXD Curve Access System Sgl, US recall: Boston Scientific has identified a higher likelihood of air embolism events
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled…
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Class I · 1+ years ago
Boston Scientific Corporation Watchman TruSeal Access System SGL, OUS recall: Boston Scientific has identified a higher likelihood of air embolism events
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled…
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Class I · 1+ years ago
Boston Scientific Corporation Watchman TruSteer Access System, US recall: Boston Scientific has identified a higher likelihood of air embolism events
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled…
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Class I · 1+ years ago
Boston Scientific Corporation Watchman FXD Curve Access Sys Dbl, OUS recall: Boston Scientific has identified a higher likelihood of air embolism events
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled…
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Class I · 1+ years ago
Boston Scientific Corporation Watchman TruSeal Access System DBL, OUS recall: Boston Scientific has identified a higher likelihood of air embolism events
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled…
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.