Microvention recalls specific endovascular embolization coil systems due to potential missing implant coils. Affected units have unique reference numbers; check your device label for details.
The devices may be missing the implant coil.
Microvention is recalling certain endovascular embolization coil systems that may be missing the implant coil. This could lead to improper treatment of vascular issues, but the recall does not specify a risk of injury or harm to users.
The devices may be missing the implant coil, which is critical for properly blocking blood flow in vascular procedures. Without the coil, the device may not function as intended, potentially leading to ineffective treatment of aneurysms or vascular malformations.
Medical professionals who use the Microvention Terumo Microplex 10 Platinum Coil System for vascular procedures are likely affected. Patients receiving these procedures are not directly at risk as the device is used by healthcare providers.
Check your device label for the reference numbers listed: 100202CSSR-V through 101036CSSR-V. Each reference number has specific lot numbers that can be found in the product description.
Look for the reference numbers on the device label to determine if your unit is affected.
The devices may be missing the implant coil, which is critical for properly blocking blood flow in vascular procedures.
Check your device label for reference numbers from 100202CSSR-V to 101036CSSR-V. Each reference number has specific lot numbers listed in the product description.
The recall does not specify a need to stop using the device; it only indicates potential missing coils. Medical professionals should check the reference numbers to confirm if their device is affected.
We’ve drafted a message you can send Microvention to request your refund or repair — edit it as you like.
Subject: Recall Z-1398-2020 — Microvention Microvention Hello, I own a Microvention that is covered by recall Z-1398-2020 from Microvention. 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.
