CLASS I Device recall · Reported 5 Jun 2019 · FDA Enforcement Report

Solopath Balloon Expandable TransFemoral System recalled

Terumo Medical is recalling Solopath Balloon Expandable TransFemoral System, distributed nationwide in the US. The recall was initiated on 26 Apr 2019 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot 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

Quantity recalled2228

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1374-2019
FDA event ID: 82705
Recalling firm: Terumo Medical, Elkton, MD
Classification: Class I
Status: Terminated
Recall initiated: 26 Apr 2019
FDA classified: 28 May 2019
Reported: 5 Jun 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

26 Apr 2019	Recall initiated by company
28 May 2019	Classified by FDA	+32 days
5 Jun 2019	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

The products were distributed US nationwide. The products were distributed to the following foreign countries: Australia, Belgium, Brazil, Canada, Portugal, Hong Kong, Peru, Singapore.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

The products were distributed US nationwide. The products were distributed to the following foreign countries: Australia, Belgium, Brazil, Canada, Portugal, Hong Kong, Peru, Singapore.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 82705

Reported	Class	Recall	Company	Reason	Where
5 Jun 2019	CLASS I	Portico Solo Re-Collapsible Access System recalled by Terumo Medical	Terumo Medical	Other	Nationwide
5 Jun 2019	CLASS I	Solopath Re-Collapsible Access System recalled by Terumo Medical	Terumo Medical	Other	Nationwide

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