Micro Therapeutics Embolization Device Recalled in Canada
Micro Therapeutics has recalled its Pipeline Flex embolization devices in Canada due to reports of serious injuries and deaths.
Products covered by the recall include the Pipeline Flex Embolization Device and the Pipeline Flex Embolization Device with Shield Technology.
Health Canada noted reports of serious injuries and deaths in connection with “delivery pushwire fracture at the distal section of the Pipeline Flex delivery system during use.”
However, patients in whom the embolization device has already been implanted successfully don’t face increased risk, the agency said.