Boston Scientific Corporation recalls Boston Scientific ROTAPRO, Rotational Atherectomy System Con
Recalled Product
Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
Hazard / Issue
Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: US Serial numbers RP005005, RP005013, RP005017, RP005036, RP005039, and RP005040, GTIN 08714729975076; EU Serial number RP005010, GTIN 08714729975151.
View official government recall
Were you affected by this recall?
If you were harmed by a recalled product, you may have legal options. Consider speaking with a consumer protection lawyer in your state.
Looking for safe alternatives?
Browse certified-safe products in this category on Amazon →
Get the next US recall alert before it hits the news.
Free. Weekly digest or instant alerts. Unsubscribe anytime.
CAN-SPAM compliant · No spam · Unsubscribe anytime