Route 92 Medical, 070 Access System, REF 1004, Rxonly… recallZ-1612-2024 · Route 92 Medical Inc · initiated Mar 8, 2024

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Route 92 Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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 protected]/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.

Recall details

Recall number: Z-1612-2024
Status: Open, Classified
Initiated by the company: Mar 8, 2024
Posted by the FDA: Apr 24, 2024
Recalling firm: Route 92 Medical Inc
Quantity: 117 units
Product code: QJP
FDA submissions: K203043
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

Product description

Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.

Code information (models, lots, serial numbers)

UDI: 00853799007442/ Lot # 23061601 24010306, 23081802, 24011801, 23100601, 24020801, 23102601

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

070 Access System Gen 1
Route 92 Medical · Catheter, Percutaneous, Neurovasculature
1 recall0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 94270).

Z-1611-2024 · Open, Classified
Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Z-1613-2024 · Open, Classified
Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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