ROUTE 92 MEDICAL INC recalls Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional d…

Recall date

March 8, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1613-2024

FDA classification

Class I

Brand / firm

ROUTE 92 MEDICAL INC

Sold / distributed

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

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.