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Reports of Serious Injuries and Death Prompt Boston Scientific S-ICD Electrode Recall

By Burg Simpson
February 5, 2021
2 min read

Boston Scientific is recalling the EMBLEM S-ICD Subcutaneous Electrode Model 3501 after learning of at least 26 reports of serious injuries and one death associated with the device. According to the FDA announcement, the device has been found to fracture and break, leading to grave outcomes.

The recalled device is a critical component of Boston Scientific’s subcutaneous implantable cardioverter defibrillator (S-ICD) system. The Boston Scientific S-ICD is implanted under the skin in the upper chest area. It is intended to monitor the heart’s activity and provide pacing for slow or fast heartbeats. If the heart beats dangerously fast, the S-ICD is designed to provide an electrical shock to prevent cardiac arrest. The recalled device plays an important role in delivering the electrical shock. Unfortunately, the device has been found to present an increased risk of fracturing that could prevent that electrical shock from being delivered. This could lead to cardiac arrest. If cardiac arrest goes untreated, a patient could suffer serious injuries or death. Indeed, Boston Scientific is already aware of numerous reports of serious injury and a death associated with the failure.

Based on current reporting, the recall affects 19,919 devices. The devices were distributed between June 2017 and February 2021. A patient whose device fails may require additional surgery to replace the component.

If you or a loved one suffered serious injury or death you suspect were caused by the Boston Scientific S-ICD’s failure, contact one of our experienced Cincinnati medical device attorneys today. Burg Simpson’s compassionate team of lawyers is prepared to seek justice and compensation for your injuries, even if it means taking on the largest manufacturers in the world.  Call 513-852-5600, or fill out our contact form for a FREE no-obligation consultation today.

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