FDA Reports Class I Recall on Some Terumo Balloon Systems

Terumo Medical recalls Solopath balloon expandable transfemoral system and re-collapsible balloon access system due to dislodgement of the fairing tip from the sheath, according to FDA statement.

• FDA has identified this as a Class I recall, the most serious type, which indicates use of recalled devices may cause serious injuries or death
• Use of affected devices could cause injuries including vessel tears, hemorrhage, and vessel perforation
• Teromo has received total of 14 reports of related incidents in which the device has malfunctioned in this manner, including two injuries
• No deaths have been reported

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