Route 92 Medical recalls full-length 070 reperfusion systems with potential for distal tip separation at the proximal marker band. Affected units include specific lot numbers from 2023-2024. Stop using immediately to prevent injury.
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Route 92 Medical is recalling certain full-length 070 reperfusion systems due to a risk of the catheter tip separating from the marker band during use. This could cause injury if the catheter dislodges during medical procedures.
The catheter's distal tip may separate from the proximal marker band during use, potentially causing the catheter to dislodge. This could lead to injury if the catheter moves unexpectedly during a medical procedure.
Healthcare professionals using the Route 92 Medical Full Length 070 Reperfusion System for neurovascular procedures are most at risk. Patients receiving these procedures may also be affected if the device malfunctions.
Check for the product name 'Route 92 Medical Full Length 070 Reperfusion System' with reference number REF: 7001. Affected units have specific lot numbers listed in the recall notice.
Discontinue use of the affected reperfusion system to prevent potential dislodgement and injury.
The catheter's distal tip may separate from the proximal marker band during use, potentially causing dislodgement and injury.
Affected units include lot numbers 223060102, 24010102, 23070501, 24010903, 23082802, 24011606, 23100404, 24012403, and 23110901.
The recall does not specify a return process, but you should stop using the product immediately to prevent injury.
We’ve drafted a message you can send Route 92 Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1611-2024 — Route 92 Medical Route 92 Medical Hello, I own a Route 92 Medical that is covered by recall Z-1611-2024 from Route 92 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.
