FDA-Device2024-04-03Class II
OptiCross Coronary Imaging Catheter, REF H749518080120
Boston Scientific Corporation
Hazard
Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
Sold states
International distribution to the country of Japan.
Affected count
239 units
Manufactured in
1 Scimed Pl, N/A, Maple Grove, MN, United States
Products
OptiCross Coronary Imaging Catheter, REF H749518080120
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1396-2024Don't want to check this manually?
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