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.
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 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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