MicoVention Terumo recalls specific LVIS Intraluminal Support Devices due to risk of stent not being pushed out of the introducer during use, potentially causing complications.
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
MicoVention Terumo is recalling a specific type of stent device for treating aneurysms. The device may not push out of the introducer catheter during use, which could lead to complications if the stent gets stuck.
The PTFE material around the stent loop might prevent the stent from being pushed out of the introducer catheter during medical procedures. If the stent gets stuck, it could cause complications like blockages or the need for additional interventions.
Patients who have received the specific MicoVention Terumo LVIS Intraluminal Support Device with the model REF: 213522-CAS, size 3.5 mm, length 22 mm, and width 18 mm are affected. Those undergoing aneurysm treatment with this device are at risk.
Check for the model REF: 213522-CAS, size 3.5 mm, length 22 mm, and width 18 mm on the device. The device is sterile and labeled with CE0297.
Look for the model REF: 213522-CAS, size 3.5 mm, length 22 mm, and width 18 mm on the device.
The specific model is MicoVention Terumo LVIS Intraluminal Support Device with REF: 213522-CAS, size 3.5 mm, length 22 mm, and width 18 mm.
The PTFE material around the stent loop may prevent the stent from being pushed out of the introducer catheter during use, potentially causing complications.
The recall record does not specify a remedy, so check with the manufacturer for further instructions.
We’ve drafted a message you can send MicoVention Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-1121-2025 — MicoVention Terumo MicoVention Terumo Hello, I own a MicoVention Terumo that is covered by recall Z-1121-2025 from MicoVention Terumo. 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.
