Recall Z-1374-2019— Terumo Medical Corporation

Name: FDA recall Z-1374-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-26

Class I · Terminated

Class I FDA medical device recall by Terumo Medical Corporation, initiated 2019-04-26, terminated 2020-09-22. It names one FDA 510(k) clearance: K100819. Product: SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-1825, STFI-1835, STFI-1925, STFI-1935, STFI-2125, STFI-2135 Product Usage: The SoloPath Balloon Expandable TransFemoral Introducer System (STFI) and the SoloPath¿ Re-Collapsible Access System are sterile, single use devices designed for low profile, large bore vessel access. Both SoloPath products are inserted percutaneously into the femoral artery, over a guidewire, and once expanded, provide a guide for catheters and/or devices introduced into the femoral/iliac arteries. The devices are designed such that surface friction is reduced during insertion while minimizing access trauma and vessel trauma throughout the procedure.. Reason: There is a potential for 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..

Recalling firm: Terumo Medical Corporation
Classification: Class I
Status: Terminated
Initiated: 2019-04-26
Terminated: 2020-09-22
Firm location: Elkton, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K100819 — THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCEROnset Medical Corporation·cleared 2010-08-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-1825, STFI-1835, STFI-1925, STFI-1935, STFI-2125, STFI-2135 Product Usage: The SoloPath Balloon Expandable TransFemoral Introducer System (STFI) and the SoloPath¿ Re-Collapsible Access System are sterile, single use devices designed for low profile, large bore vessel access. Both SoloPath products are inserted percutaneously into the femoral artery, over a guidewire, and once expanded, provide a guide for catheters and/or devices introduced into the femoral/iliac arteries. The devices are designed such that surface friction is reduced during insertion while minimizing access trauma and vessel trauma throughout the procedure.

Reason for recall

There is a potential for 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.