Terumo Medical Recalls SoloPath Balloon Expandable TransFemoral System and Re-collapsible Balloon Access System

May 31, 2019 — Terumo Medical Corp. 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. This may result in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.

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.

The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Terumo has received a total of 14 reports of related incidents in which the device has malfunctioned in this manner, including two injuries. No deaths have been reported.

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.

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;

• If you have product to return, contact Stericycle to obtain a credit and reference event number 10082. Phone Number: 855-205-2627 E-Mail: return to [email protected]; and

• E-mail the Recall Acknowledgement Form to [email protected] to arrange for product to be returned to Stericycle.

Terumo encourages customers to consider alternative suppliers.

The recall notes that all model and lot numbers are affected. See the full list of affected devices here.

Healthcare professionals and consumers may also report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by fax to 1-800-FDA-0178.

For more information: www.terumomedical.com