Terumo Medical Corporation: Medical Device Recalls in 2019

According to to data from the FDA, there were 12 medical device recalls made by Terumo Medical Corporation in 2019. See the details of the recalls below.

You can see similar recalls for other firms.

• 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.
• SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435
• Terumo Needle, 18G x 1", Product Code NN1825R
• Terumo Sur-vet Needle, 22G x 1", Product Code 100211
• Terumo Needle, 30G x 1/2", Product Code NN3013R
• Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20
• Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280
• Terumo Sur-vet Needle, 20G x 1", Product Code 100204
• Terumo Needle, 23G x 1", Product Code NN2325R
• Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215
• Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279
• Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220