Lower risk Medical device recall · FDA · Published April 26, 2019

Terumo SOLOPATH Balloon System Recall: Risk of Tip Dislodgement During Use

Terumo recalls SOLOPATH Balloon Expandable TransFemoral Systems (models STFI-1425 to STFI-2135) due to potential tip dislodgement from the sheath, which could cause loss of smooth transition during vascular procedures.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1374-2019Medical device Terumo ›

Lower-risk 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.

Take action

Contact the company

Recalling firmTerumo Medical Corporation950 Elkton Blvd · Elkton, MD 21921-5322

✎ GovInfoNow plain-language explainer

Terumo is recalling specific models of SOLOPATH Balloon Expandable TransFemoral Systems because there's a risk the device tip could become dislodged from the sheath during use. This could lead to complications in vascular procedures if the smooth transition between the tip and sheath is lost. Read more at govinfonow.com/recall/68011-terumo-solopath-balloon-system-recall-risk-of-tip-dislodgement-during.

Source Summary by GovInfoNow · govinfonow.com/recall/68011-terumo-solopath-balloon-system-recall-risk-of-tip-dislodgement-during · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1374-2019

Cite this page

“Terumo SOLOPATH Balloon System Recall: Risk of Tip Dislodgement During Use.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68011-terumo-solopath-balloon-system-recall-risk-of-tip-dislodgement-during. Based on FDA recall #Z-1374-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1374-2019%22&limit=1).

The FDA announced on April 26, 2019, that Terumo Medical Corporation voluntarily recalled SOLOPATH Balloon Expandable TransFemoral Systems due to a potential for tip dislodgement from the sheath. The agency issued recall number Z-1374-2019 for the Class I device.

How to tell if you have it

Brand: Terumo
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
Distribution: US nationwide; Australia, Belgium, Brazil, Canada, Portugal, Hong Kong, Peru, Singapore

The hazard

According to the FDA, there is a potential for dislodgement of the tip from the outer diameter of the sheath. This defect results in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.

Context

GovInfoNow's records show Terumo Medical Corporation has three other recalls on record since September 12, 2017. Other recent recalls include a June 15, 2026 recall for wrong guidewire risk and a February 8, 2019 recall for contaminated sterile product risk. Similar recent recalls of arterial sheath products include a July 9, 2026 Boston Scientific ENROUTE Transcarotid Neuroprotection System recall for tip separation and November 11, 2025 Olymp recalls for ceramic tip breakage risk.

How to tell if you have this one

Check for model numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-1825, STFI-1835, STFI-1925, STFI-1935, STFI-2125, or STFI-2135. The devices were sold with specific lot codes listed in the recall notice.

Brand
Terumo
Category
Medical device

FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Terminated
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.

Recall number	Product, codes & lots	Quantity
Z-1374-2019	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.; 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	2228
Z-1375-2019	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	1431
Z-1376-2019	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	1481

Based on the official FDA remedy

What to do — step by step

Check Device Model
Identify the model number on the device to confirm if it is one of the recalled models (STFI-1425 to STFI-2135).
Contact Manufacturer
Reach out to Terumo Medical Corporation for further assistance or to confirm if your device is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

Apr 26, 2019Firm started the recall
May 28, 2019FDA classified it Class I
Jun 5, 2019Published in FDA’s Enforcement Report
Sep 22, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/68011-terumo-solopath-balloon-system-recall-risk-of-tip-dislodgement-during">Terumo SOLOPATH Balloon System Recall: Risk of Tip Dislodgement During Use (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1374-2019 (April 26, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1374-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.