Terumo Recalls SoloPath Balloon Expandable TransFemoral Systems Due to Tip Dislodgement Risk
Terumo Medical Corporation is recalling 2,228 SoloPath Balloon Expandable TransFemoral Systems because the device tip may dislodge from the sheath, potentially causing vessel trauma.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect (tip dislodgement) that poses a risk of harm (vessel trauma) during use, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Terumo Medical Corporation is recalling 2,228 units of the SOLOPATH Balloon Expandable TransFemoral System, including model numbers STFI-1425 through STFI-2135. These sterile, single-use medical devices are designed for low-profile, large-bore vessel access via the femoral artery. The recall is due to a potential for the tip to dislodge from the outer diameter of the sheath, which would result in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.
The affected products were distributed nationwide in the United States and to foreign countries including Australia, Belgium, Brazil, Canada, Portugal, Hong Kong, Peru, and Singapore. The recall covers specific lot codes listed in the agency's documentation. No specific dates of distribution or installation are provided in the source text.
Healthcare providers and facilities should stop using the affected devices and contact Terumo Medical Corporation for further instructions on the recall process. Patients who have had these devices implanted should consult their healthcare provider regarding the potential risks associated with the device defect.
The recalled product
- 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) a
- Manufacturer
- Terumo Medical Corporation
- Category
- Medical Device — Vascular Access
- Affected units
- 2,228
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Terumo Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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