Device product
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Z-1612-2024
Product summary
- Event
- Event 94270
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 117 units
- Official record key
device-enforcement:Z-1612-2024
Official wording
Reason: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Code information: UDI: 00853799007442/ Lot # 23061601 24010306, 23081802, 24011801, 23100601, 24020801, 23102601
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