Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
OptiCross Coronary Imaging Catheter Recalled by Boston Scientific Corporation Due to Certain batches of Opticross 40MHz Coronary Imaging Catheters...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Corporation directly.
Affected Products
OptiCross Coronary Imaging Catheter, REF H749518080120
Quantity: 239 units
Why Was This Recalled?
Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
Where Was This Sold?
International distribution to the country of Japan.
About Boston Scientific Corporation
Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report