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Recall Observatory FDA recall evidence

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

March 08, 2024

Class I

Product summary

Firm
ROUTE 92 MEDICAL INC
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

    reason.no_named_rule · v1.0.0

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