FDA-Device2021-12-22Class II
Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
Boston Scientific Corporation
Hazard
Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
Sold states
Worldwide distribution - US Nationwide distribution in the states of FL, NV, NY, OH, PA, and WA. The countries of Germany.
Affected count
7 devices
Manufactured in
1 Scimed Pl, Maple Grove, MN, United States
Products
Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0381-2022Don't want to check this manually?
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