Route 92 Medical recalls Tenzing 7 Delivery Catheters (REF 1005) due to potential distal tip separation at the proximal marker band. This may cause complications during neurovascular procedures.
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Route 92 Medical is recalling Tenzing 7 Delivery Catheters (REF 1005) because they may separate at the proximal marker band during use. This could lead to complications in neurovascular procedures if not addressed.
The catheter's distal tip may separate from the proximal marker band during use. This separation could cause the catheter to become dislodged or malfunction during neurovascular procedures, potentially leading to complications.
Healthcare professionals using these catheters for neurovascular procedures are most at risk. Patients receiving these procedures may also be affected if the catheter separates during treatment.
Check for the model 'Tenzing 7 Delivery Catheter' with reference number REF 1005. These were sold with lot numbers 23033001, 23073101, 23070305, or 23081707.
Verify the catheter's reference number and lot numbers to confirm if it's affected.
The recall indicates a potential risk of distal tip separation, so it's recommended to check if your catheter is affected before use.
The recall does not specify a remedy, so contact Route 92 Medical directly for guidance.
Check for the model 'Tenzing 7 Delivery Catheter' with reference number REF 1005 and lot numbers 23033001, 23073101, 23070305, or 23081707.
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-1613-2024 — Route 9:2 Medical Route 9:2 Medical Hello, I own a Route 9:2 Medical that is covered by recall Z-1613-2024 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.
