Terumo (OTC:TRUMY;TYO:4543) is recalling a select number of its Solopath balloon expandable transferal system and re-collapsible balloon access systems due to issues with tip dislodgment from the sheath that could cause possible patient injuries.
The FDA has labeled the recall as Class I, its most severe classification which is used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
Terumo’s SoloPath balloon systems are sterile, single-use devices intended to help insert and guide placement catheters or other devices from a blood vessel to the large arteries in a patient’s thigh or hip, according to the FDA release. The systems are designed to help reduce friction during insertion and to minimize trauma during the procedure.
Terumo issued the recall due to a potential for the tip of the devices to dislodge from the outer rim of the sheath which causes a non-smooth transition from the surface of the tip to the outer surface of the expandable sheath.
The non-smooth surface edge caused by a dislodged top could result in vessel tears, false lumen, blood between the two outer layers of an artery in the hip area, vessel perforation and vessel disruption. Such issues could require additional medical interventions, increased procedure time or death, according to the FDA release.
Terumo said it has received 14 reports of related incidents in which the device tip malfunctioned, including two injuries. No deaths have been reported related to the issue, according to the FDA release.
Terumo began notifying customers on April 30, instructing customers to identify and isolate affected devices and consider alternative suppliers.
A total 3,474 devices are being recalled in the action, which affects all model and lot numbers manufactured between June 22, 2016 and January 30, 2019 and distributed between July 22, 2016 and March 13, 2019, according to an FDA release.
In April, Terumo subsidiary MicroVention released results from the WEB-IT pivotal trial of its Web aneurysm embolization system.