SOLOPATH® Voluntary Recall

  • Apr 30, 2019

Terumo Medical Corporation has initiated a voluntary recall of its SOLOPATH® Balloon Expandable TransFemoral System and the SOLOPATH® Re-collapsible Balloon Access System on April 26, 2019.

The recall is 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.  Terumo Medical has received fourteen complaints related to this issue, with two complaints resulting in serious injury for vascular damage. 

 

Product Impacted by Recall:


PRODUCT RECALLED
 

Product Name

SOLOPATH® Balloon Expandable TransFemoral System

SOLOPATH® Re-Collapsible Balloon Access System

Product Models

STFI-1425

STFI-1435

STFI-1625

STFI-1635

STFI-1825

STFI-1835

STFI-1925

STFI-1935

STFI-2125

STFI-2135

SR-1925

SR-1935

SR-2025

SR-2035

SR-2225

SR-2235

SR-2425

SR-2435

Lot Numbers

All lots within expiry

All lots within expiry

In response to declining demand for this product, accelerated by this field action, Terumo Medical 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. We encourage customers to consider alternative suppliers. A SOLOPATH® product discontinuance notification has been provided to all existing customers.  

Please be assured that we take the safety and quality of our products very seriously.  Our customers are our top priority and we want to ensure that every customer has a high-quality product that meet expectations.

Please contact the Terumo Customer Service team with any questions or concerns regarding this notification: 800.888.3786.

Contact Information: Call 855-205-2627 Monday through Friday, 8:00 AM to 4:30 PM, Central Time.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by phone.

  • Complete the voluntary Form FDA 3500 online from FDA.gov
  • Call 1-800-FDA-1088 to report by telephone