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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device

Terumo Medical Corporation: 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.

Agency Publication Date: May 28, 2019
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Affected Products

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) and the SoloPath¿ Re-Collapsible Access System are sterile, single use devices designed for low profile, large bore vessel access. Both SoloPath products are inserted percutaneously into the femoral artery, over a guidewi

Lot Codes: UG22 UG28A UK02 VA20 VN17 UG22 UK26 VA25 VC15 VG22 VN30 UH29 VA05 VG07 VG26 UH29 VH21 VK29 UH29 UK30 UP20 VF31 WG13 WK30 UH28 UK26 UL28 VD09 VH31 VM19 WP12 UG22 UG22A UH27 UH27A UL14 VA19 VG22 VM24 VP13 WG13 WL28 UG22 UH29 UL14 UL28 UN16 UP20 VA13 VC15 VD09 VH28 VK21 VL06 VL28 VM24 VN21 WG13 XA30 UG22 UL14 UN28 VH27 WM31 UN28 VG02 VP07 WN07

Lot Numbers:
Codes
Product: SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435

Lot Codes:VG26 VH21 VL20 VL29 VN29 WP05 VG02 VG07 VG13 VK29 VL18 WA25 WD02 WE25 WF09 WK01 WK09 WP05 XA09 VG06 VH27 VK04 XA09 VH27 VK07 VL28 WL14 XA30 VF31 VG16 VH21 WE25 WH23 WK01 VG09 VG14 VL14 VP18 WN07 XA09

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Codes
Product: Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20

Lot Codes: VG29 VH28 VK09 VM20 VN08 VP07 WM03 WM31 VG05 VG09 VG21 VK18 VL25 VM11 VN17 VN27 WM03 WM17

Lot Numbers:
Codes

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82705
Status: Resolved
Manufacturer: Terumo Medical Corporation
Manufactured In: United States
Units Affected: 3 products (2228; 1431; 1481)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.