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Product Advisories

Product Advisory is a voluntary letter issued to inform physicians of an anomalous device behavior identified by Boston Scientific's Quality System.

A Product Advisory is issued when there is a material elevation in risk to patient safety with potential for compromised lifesaving therapy, or when Boston Scientific can provide meaningful guidance to improve patient outcomes or device performance.

Neuromodulation - Product Advisories

Superion Indirect Decompression System (IDS) - June 2025 Removal
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Vercise Genus Deep Brain Stimulation (DBS) - August 2024 Subpec Advisory
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WaveWriter Alpha Spinal Cord Stimulation (SCS) - July 2024 Product Advisory 
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Vercise Genus Deep Brain Stimulation (DBS) - July 2024 Product Advisory Update 
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Vercise Genus Deep Brain Stimulation (DBS) - April 2024 Product Advisory 
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Superion Instruments - May 2023 Product Advisory

Cardiac Rhythm Management Product Advisories

High Internal Battery Impedance in a Subset of ACCOLADE Pacemakers and CRT-Ps - September 2025 Product Advisory Update
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RELIANCE ePTFE Potential Calcification/Gradually Rising LVSI - July 2025 Advisory
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High Internal Battery Impedance in a Subset of ACCOLADE Pacemakers and CRT-Ps - December 2024 Product Advisory
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INGENIO High Battery Impedance - November 2023 Product Advisory Update
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Model 3120 ZOOM Programmer with Model 2892 Software - November 2023 Product Advisory
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EMBLEM S-ICD Temporary Sensing Pause - July 2023 Product Advisory
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Inability to Interrogate 2868 SW on Model 3120 Programmer - July 2022 Advisory
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EMBLEM Enhanced Premature Battery Depletions - February 2022 Advisory Update
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