SOLOPATH Balloon Expandable TransFemoral System — Class I medical device recall Z-1374-2019
Terminated recall by Terumo Medical Corporation, reported 2019-06-05, distributed nationwide. There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of
| Recall number | Z-1374-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Medical Corporation, Elkton, MD, United States |
| Recall initiated | 2019-04-26 |
| Classified | 2019-05-28 |
| Reported by FDA | 2019-06-05 |
| Terminated | 2020-09-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CA, HK, PE, PT, SG |
| Quantity | 2,228 |
| Lot numbers | UG22, UG22A, UG28A, UH27, UH27A, UH28, UH29, UK02, UK26, UK30, UL14, UL28, UN16, UN28, UP20, VA05, VA13, VA19, VA20, VA25, VC15, VD09, VF31, VG02, VG07, VG22, VG26, VH21, VH27, VH28, VH31, VK21, VK29, VL06, VL28, VM19, VM24, VN17, VN21, VN30 and 9 more |
| Model numbers | STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-1825, STFI-1835, STFI-1925, STFI-1935, STFI-2125, STFI-2135 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1374-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.