Devices

FDA Issues Early Alert on Abiomed Impella Introducer Kits

FDA has issued an early alert warning healthcare providers about a potentially high-risk device issue involving introducer kits used with Impella heart pump systems manufactured by Abiomed and its manufacturing partner Oscor.

According to the agency, certain 14 French and 23 French introducer sheaths may develop unexpected leakage from the sidearm, beneath the sheath cap, or along score lines in the hub region due to manufacturing issues. The affected introducers are included in several Impella pump systems, including the Impella CP, Impella 5.5, Impella RP, and Impella RP Flex devices, and are also sold separately.

FDA said the leakage can increase the risk of access-site bleeding during sheath insertion or device manipulation. In some cases, patients may require medical intervention, including device exchange or removal, manual compression, or blood transfusions.

The agency warned that severe bleeding could be particularly dangerous in patients undergoing large-bore vascular access procedures who are receiving anticoagulation therapy or have limited physiologic reserve. In rare circumstances, undetected bleeding could result in life-threatening hemorrhage, hemodynamic instability, or death.

As of April 22, Abiomed reported eight cases of major bleeding associated with the issue and three complaints involving patient deaths. However, the company concluded that the deaths were not attributable to introducer leakage.

Rather than recalling the products, Abiomed and Oscor notified customers on June 10 and advised hospitals that existing inventory may continue to be used. Physicians were instructed to monitor patients closely and consider device replacement or use of a repositioning sheath if leakage is observed.

The affected introducers are used to facilitate catheter insertion for patients receiving Impella mechanical circulatory support devices, which are commonly used during high-risk cardiac procedures and in patients with severe heart failure or cardiogenic shock.

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