Boston Scientific Corporation is recalling approximately 6,295 units of the EXALT Model D Single-Use Duodenoscope, including 2-pack configurations, due to a defect where fluid can leak into the camera lens. This issue results in poor image quality during medical procedures, which can hinder a physician's ability to see clearly. The recall affects specific lot numbers of these single-use surgical devices distributed worldwide, including 5,709 units in the United States. Consumers should contact their healthcare provider or Boston Scientific for further instructions regarding this voluntary firm-initiated recall.
Fluid ingress into the camera lens can cause blurred or obstructed images during endoscopic procedures. This loss of visibility could lead to procedural delays, the need for additional medical interventions, or potential injury to the patient if the physician cannot clearly see the surgical site.
Manufacturer correction/return
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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