Boston Scientific Corporation recalls OptiCross Coronary Imaging Catheter, REF H749518080120

Recalled April 3, 2024 · FDA recall Z-1396-2024 · Boston Scientific

Hazard

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

Units

239 units

Sold at

International distribution to the country of Japan.

Description

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

Product

OptiCross Coronary Imaging Catheter, REF H749518080120

Manufacturer(s)

Boston Scientific Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →