Terumo recalls Portico Solo Re-Collapsible Access System models PRTSOLO-19 and PRTSOLO-20 due to potential tip dislodgement causing loss of smooth transition in medical procedures. Affected units include specific 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 two models of Portico Solo Re-Collapsible Access System because there's a risk the tip could become dislodged from the sheath during medical procedures. This could lead to complications in surgeries or procedures where the device is used.
The device's tip could become dislodged from the sheath during use, which might cause a loss of smooth transition between the tip and sheath. This could lead to complications in medical procedures, such as improper positioning or unintended tissue damage.
Medical professionals using the Portico Solo Re-Collapsible Access System for procedures like minimally invasive surgery are most at risk. Patients undergoing these procedures with the affected models may also be impacted.
Check for model numbers PRTSOLO-19 or PRTSOLO-20 on the device. Affected units also have specific lot codes: VG29, VH28, VK09, VM20, VN08, VP07, WM03, WM31, VG05, VG09, VG21, VK18, VL25, VM11, VN17, VN27, WM03, WM17.
Look for model numbers PRTSOLO-19 or PRTSOLO-20 on the device.
The tip could become dislodged from the sheath, causing a loss of smooth transition between the tip and sheath during medical procedures.
Models PRTSOLO-19 and PRTSOLO-20 with specific lot codes: VG29, VH28, VK09, VM20, VN08, VP07, WM03, WM31, VG05, VG09, VG21, VK18, VL25, VM11, VN17, VN27, WM03, WM17.
Check the model number and lot code to see if it's affected. If it is, contact Terumo for further instructions.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-1376-2019 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-1376-2019 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.
