FDA Medical Device Recalls (openFDA)
Terumo Medical Corporation: 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.
- Recall number
- Z-1374-2019
- Recalling firm
- Terumo Medical Corporation
- 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.
- Status
- Terminated
- Initiated
- 2019-04-26
- Posted
- 2019-05-28
- Terminated
- 2020-09-22
- Reason
- 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.
- Root cause
- Device Design
- Action
- Urgent Medical Device Recall letters dated 4/26/19 were sent to customers.
- Quantity
- 2228
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K100819"]
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 1118880
- Firm city
- Elkton
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28