Class II

Medical Device Recall: OptiCross Coronary Imaging Catheter, REF H749518080120

Boston Scientific Corporation · March 5, 2024

Reason for Recall

Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.

Distribution

International distribution to the country of Japan.

Quantity Affected

239 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1396-2024

Status: ongoing

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