Abiomed recalls 14Fr Low Profile Introducer Kits over thrombus risk

The FDA has issued an early alert about a recall of Abiomed 14Fr Low Profile Introducer kits, which are used with Impella CP devices.

The recall follows a higher‑than‑expected rate of complaints involving thrombus formation when the kits are used for extended periods.

On May 22, Abiomed sent a letter to affected customers advising them to review inventory, quarantine the kits, return them to Sedgwick, and inform staff who handle the devices.

Users are instructed not to use the affected kits, to post the notice in a visible area, and to contact any other facilities that may have received the kits.