ROUTE 92 MEDICAL INC: Medical Device Recall in 2024 - (Recall #: Z-1614-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: March 8, 2024

Date Posted: May 1, 2024

Recall Number: Z-1614-2024

Event ID: 94270

Reason for Recall:

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

Status: Ongoing

Product Quantity: 19 units

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

Voluntary or Mandated:

Voluntary: Firm initiated