40 recent recalls on record for Boston Scientific in connected official government data as of October 22, 2026 at 6:00 PM UTC.
Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-th…
Official ID Z-3214-2026 · Official record ↗
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 adaptor may fail elect…
Official ID Z-3188-2026 · Official record ↗
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Bu…
Official ID Z-3083-2026 · Official record ↗
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Bu…
Official ID Z-3082-2026 · Official record ↗
There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Bu…
Official ID Z-3081-2026 · Official record ↗
Potential for arterial sheath tip separation or partial tip separation during use.
Official ID Z-2978-2026 · Official record ↗
Potential for arterial sheath tip separation or partial tip separation during use.
Official ID Z-2977-2026 · Official record ↗
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Official ID Z-2962-2026 · Official record ↗
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Official ID Z-2961-2026 · Official record ↗
Potential for breach in sterile barrier of device packaging.
Official ID Z-2840-2026 · Official record ↗
Potential for breach in sterile barrier of device packaging.
Official ID Z-2839-2026 · Official record ↗
Potential for breach in sterile barrier of device packaging.
Official ID Z-2838-2026 · Official record ↗
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 user modifies an inpu…
Official ID Z-2771-2026 · Official record ↗
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orient…
Official ID Z-2757-2026 · Official record ↗
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orient…
Official ID Z-2756-2026 · Official record ↗
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orient…
Official ID Z-2755-2026 · Official record ↗
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orient…
Official ID Z-2754-2026 · Official record ↗
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
Official ID Z-2753-2026 · Official record ↗
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
Official ID Z-2752-2026 · Official record ↗
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
Official ID Z-2751-2026 · Official record ↗
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
Official ID Z-2750-2026 · Official record ↗
Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loo…
Official ID Z-2725-2026 · Official record ↗
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2637-2026 · Official record ↗
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2636-2026 · Official record ↗
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2635-2026 · Official record ↗
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2634-2026 · Official record ↗
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2633-2026 · Official record ↗
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2632-2026 · Official record ↗
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2631-2026 · Official record ↗
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2630-2026 · Official record ↗
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2629-2026 · Official record ↗
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2628-2026 · Official record ↗
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2627-2026 · Official record ↗
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2626-2026 · Official record ↗
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
Official ID Z-2580-2026 · Official record ↗
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 of the suction button …
Official ID Z-2413-2026 · Official record ↗
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 monitoring for Bradyarrhy…
Official ID Z-2049-2026 · Official record ↗
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 monitoring for Bradyarrhy…
Official ID Z-2048-2026 · Official record ↗
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 an…
Official ID Z-1771-2026 · Official record ↗
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 an…
Official ID Z-1770-2026 · Official record ↗
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Compiled from official public-domain government data. Last checked October 22, 2026 at 6:00 PM UTC.