FDA (Devices) recall action 82705
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Terumo Medical Corporation is recalling Portico Solo Re-Collapsible Access Systems because the tip may dislodge from the sheath, potentially causing injury.
Terumo Medical Corporation is recalling 1,431 SOLOPATH Re-Collapsible Access Systems because the tip may dislodge from the sheath, potentially compromising the device's smooth transition.
Terumo Medical Corporation is recalling 2,228 SoloPath Balloon Expandable TransFemoral Systems because the device tip may dislodge from the sheath, potentially causing vessel trauma.