Route 92 Medical recalls 070 Reperfusion System (REF 1003) due to potential distal tip separation at the proximal marker band during use in stroke treatments. Affected units have specific UDI and lot numbers.
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Route 92 Medical is recalling their 070 Reperfusion System (REF 1003) because there's a risk of the catheter tip separating from the marker band during procedures. This could cause complications for stroke patients needing thrombectomy treatment.
The catheter's distal tip may separate from the proximal marker band during use, potentially causing the device to malfunction. This could lead to complications during thrombectomy procedures for stroke patients.
Healthcare professionals using the system for stroke treatments are most at risk. Patients receiving thrombectomy procedures with this device may be affected if the system is used improperly.
Check for the product name 'Route 92 Medical 070 Reperfusion System' with reference number REF 1003. Affected units have UDI: 00853799007169 and lot numbers 23112702 or 23112901.
Verify the product name, reference number, and UDI/lot numbers to confirm if your device is affected.
The recall indicates a potential risk of distal tip separation, so it's recommended to check if your device is affected before use.
The recall does not specify a remedy, so check the device details to see if it's affected. If affected, contact Route 92 Medical for guidance.
Affected devices have UDI: 00853799007169 and lot numbers 23112702 or 23112901.
We’ve drafted a message you can send Route 9:2 Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1614-2024 — Route 9:2 Medical Route 9:2 Medical Hello, I own a Route 9:2 Medical that is covered by recall Z-1614-2024 from Route 9:2 Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
