ROUTE 92 MEDICAL INC Recalls

5 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (5)

March 8, 2024
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Class I
March 8, 2024
Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.
Class I
March 8, 2024
Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Class I
March 8, 2024
Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Class I
March 8, 2024
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.
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Class I

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