Product Wiki · Recalls · U.S. FDA — Device Enforcement

Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001… — recall Z-1611-2024

U.S. FDA — Device Enforcement · United States · 2024-03-08 · Class I

As described by U.S. FDA — Device Enforcement: Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1611-2024
Date of alert
2024-03-08
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
ROUTE 92 MEDICAL INC
Product category
device
Product type
Devices
Recall status
Ongoing — the recall is still in progress
Initiated by
Voluntary: Firm initiated
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
Barcode (EAN/GTIN)
00853799007497
Reported risk: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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