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Recall Observatory FDA recall evidence

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

March 08, 2024

Class I

Product summary

Firm
ROUTE 92 MEDICAL INC
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

    reason.no_named_rule · v1.0.0

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