Terumo recalls SOLOPATH Balloon Expandable TransFemoral Systems (models STFI-1425 to STFI-2135) due to potential tip dislodgement from the sheath, which could cause loss of smooth transition during vascular procedures.
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.
Terumo is recalling specific models of SOLOPATH Balloon Expandable TransFemoral Systems because there's a risk the device tip could become dislodged from the sheath during use. This could lead to complications in vascular procedures if the smooth transition between the tip and sheath is lost.
The device tip could become dislodged from the outer diameter of the sheath during vascular procedures. This might cause a loss of smooth transition between the tip and the expandable sheath, potentially leading to complications in the procedure.
Healthcare professionals using the SOLOPATH Balloon Expandable TransFemoral Systems for vascular procedures are most at risk. Patients undergoing these procedures may also be affected if the device is used incorrectly.
Check for model numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-1825, STFI-1835, STFI-1925, STFI-1935, STFI-2125, or STFI-2135. The devices were sold with specific lot codes listed in the recall notice.
Identify the model number on the device to confirm if it is one of the recalled models (STFI-1425 to STFI-2135).
Reach out to Terumo Medical Corporation for further assistance or to confirm if your device is affected.
The recalled models are STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-1825, STFI-1835, STFI-1925, STFI-1935, STFI-2125, and STFI-2135.
There is a potential for the tip to become dislodged from the sheath during use, which could cause a loss of smooth transition between the tip and the expandable sheath.
Check the model number to see if it is recalled, then contact Terumo Medical Corporation for further instructions.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-1374-2019 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-1374-2019 from Terumo. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
