Hazard description
Abiomed has initiated a voluntary medical device recall (correction) for all currently distributed Introducer kits that are used with Impella heart pumps to notify customers of a potential for unexpected introducer sheath leakage from the sidearm and under the sheath cap and along the hub score lines in the hub region. Introducer leakage may impair hemostasis and increase the risk of access-site bleeding, particularly in anticoagulated patients. This information is provided to support appropriate clinical awareness, monitoring, and patient support as needed. The identified defect does not affect any other packaged products within the pump set.
RecallTracker