Medical device manufacturer, Terumo, has issued a medical device safety alert concerning its Terumo SOLOPATH Balloon Expandable TransFemoral System and SOLOPATH Re-collapsible Balloon Access System. The affected products are identified as following:
The recall has been initiated in response to confirmed reports of dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath. The "Instructions for Use" instruct the user to visually inspect the device prior to use in order to ensure a smooth transition exists between the distal end of the sheath and the balloon expander. However, inadvertent use of a device with this condition may result in procedural complications and vascular damage. The manufacturer has received fourteen complaints related to this issue, with two complaints resulting in serious injury for vascular damage.
Affected users are advised to review the inventory immediately to identify and isolate affected inventory in order to prevent future use, and plan accordingly with alternative suppliers.
In response to declining demand for this product, accelerated by this field action, the manufacturer has made the decision to permanently discontinue the manufacturing of SOLOPATH. As a result, effective immediately no future restocking orders or new orders for SOLOPATH will be fulfilled.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 6 May 2019