Route 92 Medical Access System (Unknown) – Distal Tip Separation (2024)
Potential distal tip separation can compromise medical device performance during intervention.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Lot Codes / Batch Numbers
UDI: 00853799007442/ Lot # 23061601 24010306, 23081802, 24011801, 23100601, 24020801, 23102601
Products Sold
UDI: 00853799007442/ Lot # 23061601 24010306, 23081802, 24011801, 23100601, 24020801, 23102601
A medical device manufacturer is recalling Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interv due to Their is the potential for distal tip separation at the proximal marker band of the delivery catheters. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Recommended Action
Per FDA guidance
On March 12, 2024 Route 92, issued a Urgent Medical Device recall notification to affected consignees via Mail and EMail. Route 92 asked consignees to take the following actions: Ensure all of your SUMMIT MAX inventory including the affected 070 Reperfusion Systems is in a secure, quarantined location. 2. Complete the Acknowledgement Form in Attachment 2 and return to Route 92 Medical by one of the following methods: Email-FieldActions@route92medical.com/Standard Mail - Attention Line: Tenzing 7 fiedl action, 155 Bovet Road Suite 100, San Mateo, CA 94402 Please return the Acknowledgement Form even if you no longer have the product subject to this recall. 4. Immediately return any affected products with the specific lot numbers listed in Attachment 1 to the address above using the original shipping container or request a new shipping container and pre-printed shipping label by email. 5. Keep this notice until all product subject to this recall has been returned. While processing your returns, please maintain a copy of this notice with the quarantined product subject to this recall and keep a copy for your records. 6. Separately, as part of SUMMIT MAX closure, you will be sending back your remaining SUMMIT MAX inventory if you haven t done so already.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, CA, DE, FL, GA, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NJ, NY, NC, ND, OH, OR, PA, RI, SD, TN, TX, UT, VA, WV
Page updated: Jan 10, 2026