The United States Food and Drug Administration (FDA) is alerting the public and health care providers that Reprocessed Agilis Steerable Introducer Sheath, manufactured by Sterilmed Inc. The affected devices are identified as the following:-
According to the FDA, the Agilis Steerable Introducer Sheath's hemostatic valve, which prevents blood from flowing back through the valve, may fail due to an improper seal of the sheath hub. Improper seals 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 (air embolism).
The improper seal 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. Patients with a lower body mass index (BMI) may be more at risk if blood loss occurs. Smaller patients and patients with pre-existing decreased pulmonary reserve may be more susceptible to air embolism. The use of affected products may cause serious health consequences for patients, including death.
The manufacturer has provided the following instructions for health care facilities and providers:
For details, please refer to the FDA website:
https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm590903.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 04 January 2018