Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported June 5, 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 guidewi
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 surfac…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Terumo Medical Corporation recalled SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, … - a critical-severity action.
SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, … was recalled by Terumo Medical Corporation in June 5, 2019. Reason: There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of…. Check the official notice for the remedy. Verify recall #Z-1374-2019 with the FDA Devices before acting.
The recall
Terumo Medical Corporation issued this critical-severity FDA Devices recall-There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of….
- Critical
- severity level
- 2K units
- affected scope
- Class I
- classification
- June 5, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1374-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1374-2019) was formally reported on June 5, 2019, with the manufacturer initiating the action on April 26, 2019. It is classified under Critical severity (Class I), with a current status of Terminated. Terumo Medical Corporation is listed as the recalling firm, operating out of Elkton, MD. Federal records list the affected scope as 2228.
The documented reason for this recall is: 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 data in the federal record shows the product reached: The products were distributed US nationwide. The products were distributed to the following foreign countries: Australia, Belgium, Brazil, Canada, Portugal, Hong Kong, Peru, Singapore.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2228
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1374-2019 |
| Date reported | June 5, 2019 |
| Date initiated | April 26, 2019 |
| Recalling firm | Terumo Medical Corporation |
| Firm location | Elkton, MD |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1374-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Terumo Medical Corporation. Units affected: 2228.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 5, 2019. Severity: Critical. Recall number: Z-1374-2019.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1374-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 5, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.