Boston Scientific Corporation is recalling 239 units of OptiCross Coronary Imaging Catheters (Model REF H749518080120) because they were manufactured using an incorrect voltage setting. This manufacturing defect can lead to decreased image brightness during medical procedures, which may interfere with a physician's ability to clearly see the coronary arteries. These specific catheters were distributed internationally to Japan and were manufactured in the United States. Because these are specialized medical devices, you should contact your healthcare provider or the manufacturer regarding the next steps for any affected units.
The incorrect voltage setting during manufacturing causes a reduction in image brightness, which can prevent doctors from obtaining clear diagnostic images during heart catheterization procedures. This lack of visibility could lead to procedural delays or difficulties in accurately assessing a patient's condition.
Contact healthcare provider or manufacturer
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.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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