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# Terumu Recalls Catheter Placement Devices
- URL: https://www.fdaweb.com/terumu-recalls-catheter-placement-devices/
- Published: 2019-05-30T12:00:00.000Z
- Updated: 2026-09-15T01:29:39.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144225

Terumo Medical has recalled its Solopath Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System due to the potential for the tip to dislodge from the outer rim 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. “Use of the affected devices could cause vessel tears (dissection), false lumen, blood between the two outer layers of an artery (pseudoaneurysm), hemorrhage, inability to transition through the skin to the iliac artery in the hip area, vessel perforation, and vessel disruption, which may result in additional medical intervention, increased procedure time, or death,” a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/terumo-medical-corporation-recalls-solopathr-balloon-expandable-transfemoral-system-and-re?utm%5Fcampaign=2019-05-30%20CDRH%20Recall%20SOLOPATH%20Balloon&utm%5Fmedium=email&utm%5Fsource=Eloqua) says.

The single-use devices are designed to help insert and guide placement of catheters or other medical devices from a blood vessel to the large arteries in a patient’s thigh or hip (femoral or iliac artery). They are also used to help reduce friction during insertion and to minimize trauma throughout the procedure, the company says. Terumo has received 14 reports of related incidents in which the device has malfunctioned, including two injuries.