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The U.S. Food and Drug Administration (FDA) is aware that Abiomed and Oscor sent affected customers a letter recommending all Introducer Kits used with Impella heart pumps be corrected prior to continued use. Abiomed has identified a potential for introducer sheath leakage in 14Fr and 23Fr Introducers from the sidearm, under the sheath cap, and along the hub score lines in the hub region. The unexpected leakage in these locations is due to certain manufacturing issues that increase the risk of access-site bleeding.
Introducer leakage may result in access site bleeding at the time of sheath insertion or early device manipulation. This may cause blood loss requiring medical intervention, such as device exchange or removal, manual compression, and, in some cases, blood transfusion. In certain circumstances, particularly patients undergoing large bore vascular access with systemic anticoagulation or limited physiologic reserve (with a bleed that went undetected), exposure to this hazard may result in life-threatening hemorrhage and hemodynamic instability which may lead to death.
As of April 22, Abiomed has reported eight instances of major bleeding associated with this issue. The firm also received three complaints of corresponding patient deaths, but Abiomed has determined that the deaths were not attributable to introducer leakage.
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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