FDA recall Z-1396-2024

Boston Scientific Corporation · Class II · device

Product

OptiCross Coronary Imaging Catheter, REF H749518080120

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.

Key facts

Status: Ongoing
Initiation date: 2024-03-05
Report date: 2024-04-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Maple Grove, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1396-2024