The Food and Drug Administration said in a news alert that Terumo Medical Corporation is recalling the SOLOPATH Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System due to a potential for the tip to dislodge from the outer rim 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.
FDA says use of the affected devices could cause vessel tears (dissection), false lumen, blood between the two outer layers of an artery (pseudoaneurysm), hemorrhage, inability to transition through the skin to the iliac artery in the hip area, vessel perforation, and vessel disruption, which may result in additional medical intervention, increased procedure time, or death.
No deaths have been reported but FDA says the firm has received a total of 14 reports of related incidents in which the device has malfunctioned in this manner, including two injuries.
The SoloPath Balloon Expandable TransFemoral Introducer System (STFI) and the SoloPath Re-Collapsible Access System (SR) are sterile, single use devices designed to help insert and guide placement of catheters or other medical devices from a blood vessel to the large arteries in a patient's thigh or hip (femoral or iliac artery). The devices are designed to help reduce friction during insertion and to minimize trauma throughout the procedure.
FDA said on April 30, 2019, Terumo sent customers a product discontinuance notification and a voluntary recall notice to customers, which listed the following actions:
· Review the Product Recall Bulletin and the Required Actions.
· Assure that all users receive notice of this issue so that required actions can be performed.
· Assure that this notice is forwarded to applicable facilities if any affected products were further distributed outside of your facility.
· Review your SOLOPATH inventory immediately to identify and isolate affected inventory to prevent future use.
· Complete the Medical Device Recall Response Form. The form is required even if you do not have product to return.