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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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."
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)…
- 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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