Class I

Medical Device Recall: 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.

ROUTE 92 MEDICAL INC · March 8, 2024

Reason for Recall

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

Distribution

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

States Affected

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

Quantity Affected

19 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1614-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

ROUTE 92 MEDICAL INC Medical Device Recall: 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. | SafeCheck