Device product
Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Z-1613-2024
Product summary
- Event
- Event 94270
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 200 units
- Official record key
device-enforcement:Z-1613-2024
Official wording
Reason: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Code information: UDI: 00853799007534/ Lot # 23033001, 23073101, 23070305, 23081707
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