Terumo recalls specific SOLOPATH Re-Collapsible Access System models due to potential tip dislodgement from the sheath, risking loss of smooth transition. Affected units include model numbers SR-1925 to SR-2435 with listed lot codes.
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.
Terumo is recalling certain SOLOPATH Re-Collapsible Access Systems because the tip could become dislodged from the sheath, potentially causing a loss of smooth transition. This could affect medical procedures requiring precise device placement.
The tip of the device could become dislodged from the sheath during use, leading to a loss of smooth transition between the tip and sheath. This might cause improper device placement or complications during medical procedures.
Medical professionals using the SOLOPATH Re-Collapsible Access System for procedures like vascular access are most at risk. Patients receiving these devices during medical treatments may also be affected.
Check for model numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, or SR-2435. The lot codes listed in the recall include VG26, VH21, VL20, and other specific codes.
Identify if your device has model numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, or SR-2425.
Check if your device's lot code matches the listed codes such as VG26, VH21, or VL20.
The recall affects SOLOPATH Re-Collapsible Access System models SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, and SR-2425.
Lot codes such as VG26, VH21, VL20, VL29, VN29, and others are listed in the recall.
The recall record does not specify a remedy.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-1375-2019 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-1375-2019 from Terumo. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
