SOLOPATH® PRODUCT DISCONTINUANCE NOTIFICATION

Apr 30, 2019

This product bulletin pertains to the discontinuance of the SOLOPATH® Balloon Expandable TransFemoral System & the SOLOPATH® Re-collapsible Balloon Access System.

Attention:      Interventional Cardiologist, Interventional Radiologist, Vascular Surgeon, Catheter Lab / Operating Room Manager

Discontinued     SOLOPATH® Balloon Expandable TransFemoral System
Product Line: 
    SOLOPATH® Re-collapsible Balloon Access System

Date:  April 30, 2019           

                                      

Dear Valued Customer,

Terumo Medical Corporation/Terumo Medical Canada Inc. initiated a voluntary recall on April 26, 2019 of SOLOPATH® Balloon Expandable TransFemoral System & the SOLOPATH® Re-collapsible Balloon Access System in response to confirmed reports of dislodgement of the tip from the outer diameter of the sheath. 

This letter serves as formal notification that Terumo Medical Corporation (TMC) will discontinue the manufacturing of SOLOPATH® Balloon Expandable TransFemoral System & the SOLOPATH® Re-collapsible Balloon Access System, effective immediately.  Please plan accordingly with alternative suppliers.

 

SOLOPATH PRODUCT SKUS

SOLOPATH RE-COLLAPSIBLE PRODUCT SKUS

STFI-1425

SR-1925

STFI-1435

SR-1935

STFI-1625

SR-2225

STFI-1635

SR-2235

STFI-1825

SR-2425

STFI-1835

SR-2435

STFI-1925

 

STFI-1935

 

STFI-2125

 

STFI-2135

 

 

We regret any inconvenience this action may cause your care delivery strategies and we appreciate your understanding.

 

QUESTIONS?

We encourage you to contact TMC with any questions or concerns:

  • Customer Care: 1.800.888.3786 or Contact your local Terumo representative

Please share this letter with clinicians in your facility who utilize these devices; by either forwarding to or posting in areas where these products are used.