Microvention recalls HydroSoft 10 and HydroCoil Embolic Systems with missing implant coils. Affected units have specific Rx/REF numbers. Contact Microvention for details.
The devices may be missing the implant coil.
Microvention is recalling certain endovascular embolization coils that may be missing the implant coil. This could lead to improper treatment of vascular malformations or aneurysms.
The devices may be missing the implant coil, which is critical for properly blocking blood flow to an aneurysm or vascular malformation. Without the coil, the procedure may not work as intended.
Medical professionals using the HydroSoft 10 or HydroCoil Embolic Systems for endovascular procedures. Patients who have received these coils during treatment are most at risk.
Check for Rx/REF numbers on the label: 100101H2HS-V through 100620H2HS-V and MV-00208HHSA. Also look for specific lot numbers like 1903135UR or 1904175WR.
Look for the Rx/REF number on the device label to confirm if it's affected.
Reach out to Microvention for specific instructions on whether your device is affected.
The devices may be missing the implant coil, which is critical for properly blocking blood flow to an aneurysm or vascular malformation.
Check the product label for the Rx/REF number and contact Microvention for specific instructions.
The recall is for medical devices used in procedures; patients who received the coils during treatment may need to follow up with their healthcare provider.
We’ve drafted a message you can send Microvention to request your refund or repair — edit it as you like.
Subject: Recall Z-1392-2020 — Microvention Microvention Hello, I own a Microvention that is covered by recall Z-1392-2020 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.
