Route 92 Medical recalls 070 Access System (REF 1004) due to potential distal tip separation at the proximal marker band during use. 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 its 070 Access System (REF 1004) because there's a risk of the catheter tip separating from the marker band during use. This could lead to complications if the catheter becomes dislodged during medical procedures.
The catheter's distal tip may separate from the proximal marker band during use, potentially causing the catheter to become dislodged. This could lead to complications such as bleeding or other issues during medical procedures.
Healthcare professionals using the 070 Access System for neurovascular interventions are most at risk. Patients receiving these procedures may also be affected if the system is used improperly.
Check for the UDI code 00853799007442 and lot numbers 23061601, 23081802, 24010306, 23100601, 24011801, 23102601 on the packaging or label.
Look for the UDI code 00853799007442 and specific lot numbers on the packaging or label.
The risk is that the catheter tip may separate from the marker band during use, potentially causing dislodgement and complications during medical procedures.
Check for the UDI code 00853799007442 and lot numbers 23061601, 23081802, 24010306, 23100601, 24011801, 23102601 on the packaging or label.
The recall record does not specify a remedy, so contact Route 92 Medical directly for guidance.
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-1612-2024 — Route 92 Medical Route 92 Medical Hello, I own a Route 92 Medical that is covered by recall Z-1612-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
