Sterilmed Inc., is recalling the Sterilmed Reprocessed Agilis Steerable Indroducer Sheath, used with various cardiovascular catheters, due to a defect in the seal of the sheath that, if used, may lead to serious health complications, including death.
The hemostatic valve is used to insert and position various cardiovascular catheters in the heart, including on the left side of the heart through the wall of tissue that separates the right and left chambers of the heart, called the interatrial septum. The device prevents blood from flowing back through the valve.
The recall is being initiated because the device may fail due to an improper seal of the sheath hub. This can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that allows air into the circulatory system, creating an air embolism.
This seal defect occurs when not enough glue is used to reattach the cap to the hub after reprocessing. Too much glue can also block the sheath valve and make the device unusable.
The issue affects patients undergoing cardiac catherization procedures. Those with a lower body mass index may be at grater risk of blood loss. Smaller patients and patients with pre-existing decreased pulmonary reserve may be more susceptible to air embolism.
Sterilmed has contacted health care facilities and providers with instructions to inspect their inventory for affected products, discontinue use with these products, and to continuously monitor patients treated with the Sterilmed Reprocessed Agilis Steerable Introducer Sheath as normal.
Any adverse events related to this recall should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice