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ROUTE 92 MEDICAL INC recalls Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices i
Recalled May 1, 2024 · FDA recall Z-1614-2024 · ROUTE 92 MEDICAL
Hazard
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters · FDA Class I
Units
19 units
Sold at
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
Description
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Product
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.
Manufacturer(s)
ROUTE 92 MEDICAL INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →