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Recall Observatory FDA recall evidence

Device product

Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and aspiration of thrombus in ischemic stroke patients.

Z-1614-2024

March 08, 2024

Class I

Product summary

Firm
ROUTE 92 MEDICAL INC
Event
Event 94270
Status
Ongoing
Classification
Class I
Quantity
19 units
Official record key
device-enforcement:Z-1614-2024

Official wording

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

Code information: UDI: 00853799007169/ Lot # 23112702 and 23112901

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