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Early Alert: WATCHMAN Access System Issue from Boston Scientific
The FDA is aware that Boston Scientific has issued a letter to affected customers recommending all lots of certain WATCHMAN Access Systems have updated use instructions. Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation.
The risk of air embolism is acute in nature and limited to the duration of the implant procedure. Patients who have a previously implanted WATCHMAN device do not require additional patient management and should continue to follow standard patient care at the discretion of their physician.
As of July 30, Boston Scientific has reported 120 serious injuries and 17 deaths associated with this issue.
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Boston Scientific at ICardioQAComplaints@bsci.com.
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