Microvention recalls specific HydroFrame 10 and HydroCoil Embolic System products that may be missing the implant coil, which could lead to incomplete treatment of vascular issues.
The devices may be missing the implant coil.
Microvention is recalling certain HydroFrame 10 and HydroCoil Embolic Systems that may be missing the implant coil. This could cause incomplete treatment of vascular issues like aneurysms or malformations.
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 achieve the intended vascular occlusion.
Medical professionals using these devices for endovascular procedures are most at risk. The affected products are specific model numbers and lot numbers listed in the recall.
Check for the REF numbers listed: 100306HFRM-V through 101036HFRM-V and MV-00408HHFA through MV-00619HHFA. Also look for the specific lot numbers provided in the recall notice.
Review the REF numbers and lot numbers listed in the recall notice to confirm if 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 REF numbers and lot numbers listed in the recall notice to confirm if your device is affected. If it is, you should contact Microvention for further instructions.
Yes, the missing coil could lead to incomplete treatment of vascular issues, potentially requiring additional procedures.
We’ve drafted a message you can send Microvention to request your refund or repair — edit it as you like.
Subject: Recall Z-1402-2020 — Microvention Microvention Hello, I own a Microvention that is covered by recall Z-1402-2020 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.
