Medical device manufacturer, Terumo Medical Corporation, has issued a safety alert concerning its FemoSeal Vascular Closure Systems [Product Reference Code: C11202].
The manufacturer is initiating a voluntary recall of select production lots of FemoSeal Vascular Closure Systems in response to an increase in device related malfunction complaints. Specifically, after the deployment of the inner locking disc, complaints allege that the button will not spring back as intended, preventing the outer locking disc from deploying and completing the procedure. When this failure occurs, options for the clinician include manual compression or surgical cut down.
Upon further review, devices associated with this complaint mode (approximately 1/600 per current complaint date) reflect the internal entrapment of the device's suture assembly. Suture entrapment prevents the proper actuation of the device to complete the surgical procedure. Internal controls have been established in manufacturing to eliminate the potential for this defect.
Product replacement is on-going.
According to the local supplier, the affected products are distributed in Hong Kong
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 22 August 2017