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Early Alert: Catheter Introducer Kit Issue from Abiomed
The FDA is aware that Abiomed has issued a letter to affected customers recommending all 14Fr Low Profile Introducer Kits be removed from where they are used or sold.
Abiomed has identified a high rate of complaints related to thrombus formation on the 14Fr Low Profile Introducer Kit during prolonged use of the introducer. If thrombus formation occurs, the user may have difficulty aspirating the sheath sidearm or valve. The user may also observe thrombus in the syringe or sidearm post aspiration or around the valve following CP pump removal.
Thrombus formation within the indwelling sheath lumen or the annular gap between the sheath inner diameter and the catheter outer diameter during prolonged support may result in disruption of blood flow near the access site. If thrombus is dislodged during ongoing support, manipulation, or removal, this may result in peripheral vessel obstruction with ischemia requiring prompt clinical assessment and intervention to restore perfusion. Under less common circumstances, exposure could progress to irreversible vascular occlusion with potential for permanent impairment if not corrected.
As of May 15, Abiomed has reported three serious injuries and no deaths associated with this issue.
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Abiomed at OneMD-Field-Actions@its.jnj.com.
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