Abiomed is removing 14Fr Low Profile Introducer Kits from the market. FDA’s website has the release.

Abiomed has “identified a higher rate of complaints than expected 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.”

If an error along these lines occurs, “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.”

The recall includes the Impella CP 10th generation pump set, since that is the only pump set the kit is compatible with. As of May 15, three serious injuries and no deaths were associated with the recall.

Abiomed advises those potentially affected to review their inventories, return any affected product, and notify anyone in their facility who uses these devices.