The U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding Abiomed's 14Fr Low Profile Introducer Kits, following a high rate of complaints concerning thrombus formation during prolonged use. Abiomed has recommended that all affected kits be removed from use or sale.
Thrombus formation within the introducer kit can lead to difficulty aspirating the sheath sidearm or valve, and users may observe clots in the syringe or around the valve. This can disrupt blood flow near the access site, potentially causing peripheral vessel obstruction, ischemia, and, in less common cases, irreversible vascular occlusion with permanent impairment if not corrected.
As of May 15, Abiomed has reported three serious injuries associated with this issue, with no deaths. The FDA's Center for Devices and Radiological Health (CDRH) said it "is issuing this Early Alert to notify the public of a potentially high-risk device issue," and stated that it "will keep the public informed and update this web page as significant new information becomes available."