FDAFDA · Food and drugs·Recall number Z-1614-2024
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.
Published May 1, 2024 · Recall initiated: March 8, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ROUTE 92 MEDICAL INC
- Distributor
- 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
- Lot
- UDI: 00853799007169/ Lot # 23112702 and 23112901
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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