Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Reported: May 1, 2024 Initiated: March 8, 2024 #Z-1611-2024
Product Description
Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Reason for Recall
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Details
- Recalling Firm
- ROUTE 92 MEDICAL INC
- Units Affected
- 750 units
- Distribution
- 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
- Location
- San Mateo, CA
Frequently Asked Questions
What product was recalled? ▼
Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.. Recalled by ROUTE 92 MEDICAL INC. Units affected: 750 units.
Why was this product recalled? ▼
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 1, 2024. Severity: Critical. Recall number: Z-1611-2024.
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