FDA recall Z-1612-2024

ROUTE 92 MEDICAL INC · Class I · device

Product

Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.

Reason for recall

Their is the potential for distal tip separation at the proximal marker band of the delivery catheters

Distribution

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

Key facts

Status
Ongoing
Initiation date
2024-03-08
Report date
2024-05-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Mateo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1612-2024