Z-1374-2019Class I

SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635...

Name: Z-1374-2019 SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635...
Creator: Terumo Medical Corporation
Published: 2019-04-26
License: https://open.fda.gov/license/

Terumo Medical Corp. / initiated 2019-04-26 / Terminated / root cause: design

FDA source

Terumo Medical Corporation began a recall of SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-1825, STFI-1835, STFI-1925, STFI-1935... on 2019-04-26. FDA classified it as Class I and 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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1374-2019
Classification: Class I
Status: Terminated
Initiated: 2019-04-26
Posted: 2019-05-28
Terminated: 2020-09-22
Recalling firm: Terumo Medical Corp.
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.
Product code: DYB Introducer, Catheter
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.
Root cause tag: design
FDA root cause: Device Design
Action: Urgent Medical Device Recall letters dated 4/26/19 were sent to customers.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1374-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1374-2019	Class I	Terminated	Voluntary: Firm initiated	2019-06-05	2019-05-28
Z-1375-2019	Class I	Terminated	Voluntary: Firm initiated	2019-06-05	2019-05-28
Z-1376-2019	Class I	Terminated	Voluntary: Firm initiated	2019-06-05	2019-05-28

Product code DYB

K100819Class IIThe Solopath Balloon Expandable Transfemoral IntroducerOnset Medical Corporation / cleared 2010-08-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)