# FDA recall Z-1374-2019 > **Terumo Medical Corporation** · Class I · device recall initiated 2019-04-26. ## 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 guidewire, and once expanded, provide a guide for catheters and/or devices introduced into the femoral/iliac arteries. The devices are designed such that surface friction is reduced during insertion while minimizing access trauma and vessel trauma throughout the procedure. ## Reason for recall 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. ## Distribution The products were distributed US nationwide. The products were distributed to the following foreign countries: Australia, Belgium, Brazil, Canada, Portugal, Hong Kong, Peru, Singapore. ## Key facts - **Recall number:** Z-1374-2019 - **Recalling firm:** Terumo Medical Corporation - **Classification:** Class I - **Product type:** device - **Status:** Terminated - **Initiation date:** 2019-04-26 - **Report date:** 2019-06-05 - **Termination date:** 2020-09-22 - **Voluntary/Mandated:** Voluntary: Firm initiated - **Location:** Elkton, MD, United States ## Primary source FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1374-2019 ## Citation > AI Analytics. FDA recall Z-1374-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1374-2019. Source: US FDA. Licensed CC0. --- *[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*