Reported Jun 5, 2019 · Terminated
SOLOPATH Balloon Expandable TransFemoral System, Model Numbers STFI-1425, STFI-1435, STFI-1625, STFI-1635, STFI-1825,…
Terumo Medical Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Terumo Medical Corporation · 950 Elkton Blvd · Elkton, MD · 21921-5322
Is this the product you have?
- 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 UsageThe 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 and dates
- Lot Codes
68 of 68 codes
UG22UG28AUK02VA20VN17UG22UK26VA25VC15VG22VN30UH29VA05VG07VG26UH29VH21VK29UH29UK30UP20VF31WG13WK30UH28UK26UL28VD09VH31VM19WP12UG22UG22AUH27UH27AUL14VA19VG22VM24VP13WG13WL28UG22UH29UL14UL28UN16UP20VA13VC15VD09VH28VK21VL06VL28VM24VN21WG13XA30UG22
- Lot Codes
- Amount recalled
- 2228
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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