Device product
Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Z-1611-2024
Product summary
- Event
- Event 94270
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 750 units
- Official record key
device-enforcement:Z-1611-2024
Official wording
Reason: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Code information: UDI: 00853799007497/ Lot # 223060102, 24010102, 23070501, 24010903, 23082802 24011606 , 23100404, 24012403 , 23110901
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