Device 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.
Z-1614-2024
Product summary
- Event
- Event 94270
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 19 units
- Official record key
device-enforcement:Z-1614-2024
Official wording
Reason: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Code information: UDI: 00853799007169/ Lot # 23112702 and 23112901
Distribution pattern: 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
Derived failure modes
-
Unknown
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters