The U.S. Food and Drug Administration issued a recall for the WIRION Embolic Protection Device, which can cause serious injury or even death to users. All models of the heart device are included in the Class I recall – the most serious type of recall the agency conducts. The problems typically come from filter breakage during retrieval of the device.
WIRION Embolic Protection Devices were manufactured between January and August of 2021, and distributed between March and November of 2021. The company officially issued a recall on Nov. 22, 2021, and the FDA is still working to get the word out. The device is meant to hold and remove blood clots from the lower limbs that would otherwise cause health problems during surgery, but the parent company, Cardiovascular Systems Inc., reportedly received numerous complaints about the filters breaking during retrieval.
If surgeons are unable to fully retrieve the WIRION device intact from a patient, the broken components can have serious health risks, including embolization. In these cases, removing the filter could require an entirely different medical procedure, and could even result in death.
For the most part, this recall will not impact patients on the consumer level, but is instead directed at hospitals and surgeons, as well as the distributors of medical equipment. Cardiovascular Systems Inc., is asking all of them to remove the devices from their inventory and contact the company for instructions on disposing of them and getting a refund. However, patients receiving atherectomy procedures might want to inquire about the recall with their doctor just for peace of mind.
So far, Cardiovascular Systems Inc. has documented reports of nine WIRION device malfunctions, but no deaths. The company counts 697 WIRION devices in circulation in the United States. Customers who believe they have been impacted by these recalled devices can also contact the FDA's Safety Information and Adverse Event Reporting Program, MedWatch, using a form available online here. It can be submitted online, via mail or via fax. Questions can also be directed to Cardiovascular Systems Inc. via phone at 651-259-2800.
Class I recalls are rare at the FDA and are reserved for serious cases. The agency has four lower classifications for product recalls, including Class II, Class III, Market withdrawal and "Medical device safety alert." A Class I recall like this is conducted only when "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."