According to a notice posted by the US Food and Drug Administration (FDA), Cardiovascular Systems Inc (CSI), has recalled the Wirion embolic device (Wirion). There were concerns that the filter could break during the retrieval.
The Wirion system is used to hold and remove blood or debris clots from lower limbs during atherectomy procedures.
“Under certain circumstances, like when the filter basket is overflowing, the filter assembly may be difficult to remove. In this scenario, withdrawal could cause the Wirion system’s filter component to break or split, which may result in several adverse events, such as embolization, the requirement for additional medical procedures or possibly death,” the recall notice states.
The FDA has classified this as a Class I recall, the most serious type due to the potential for grave injury or death.
CSI has received nine reports of device malfunctions. There have been no deaths.
All products and lots of Wirion (Model: WRN D6) which were manufactured between January 3 2021 and August 16 2021 and distributed nationwide between March 22nd, 2021 and November 15 2021 are covered in the recall.
A total of 697 devices were removed.
CSI, a Minnesota-based company that is based in Minnesota, has sent an urgent recall notice to all affected customers, asking them to stop using Wirion products and return any unopened product to the company.
Doctors and healthcare providers can reach their CSI representative by dialing 651-259-2800.
Recalls that cause adverse reactions or cause quality issues must be reported to the FDA’s MedWatch program.
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