ROUTE 92 MEDICAL INC recalls Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices i…

Recall date

March 8, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1614-2024

FDA classification

Class I

Brand / firm

ROUTE 92 MEDICAL INC

Sold / distributed

US: AL AZ CA DE FL GA IA IL IN KY LA MA MD MI MN MO NC ND NJ NY OH OR PA RI SD TN TX UT VA WV OUS: New Zealand

Why it was recalled

Their is the potential for distal tip separation at the proximal marker band of the delivery catheters

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and aspiration of thrombus in ischemic stroke patients.