Terumo SOLOPATH Re-Collapsible Access System Recalled for Tip Dislodgement Risk
Terumo Medical Corporation is recalling 1,431 SOLOPATH Re-Collapsible Access Systems because the tip may dislodge from the sheath, potentially compromising the device's smooth transition.
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, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Terumo Medical Corporation is recalling 1,431 units of the SOLOPATH Re-Collapsible Access System, including model numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, and SR-2435. The recall was initiated due to a potential for the tip to dislodge from the outer diameter of the sheath. This defect may 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. Specific lot codes associated with the recall include VG26, VH21, VL20, VL29, VN29, WP05, VG02, VG07, VG13, VK29, VL18, WA25, WD02, WE25, WF09, WK01, WK09, XA09, VG06, VH27, VK04, VK07, VL28, WL14, XA30, VF31, VG16, WH23, VG09, VG14, VL14, VP18, and WN07.
Healthcare providers and consumers should check their inventory for these specific model numbers and lot codes. If the product is found, it should be removed from use and returned to the manufacturer or an authorized distributor in accordance with the recall instructions.
The recalled product
- Product
- SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435
- Manufacturer
- Terumo Medical Corporation
- Category
- Medical Device — Vascular Access
- Affected units
- 1,431
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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