Reported Dec 22, 2021 · Terminated
Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 1 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
- Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
- Lot codes and dates
US Serial numbers RP005005RP005013RP005017RP005036RP005039and RP005040GTIN 08714729975076EU Serial number RP005010GTIN 08714729975151
- Amount recalled
- 7 devices
Where it was sold
Why it was recalled
Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
This product could cause temporary or reversible health problems — stop using it.
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