Microvention recalls certain Microplex 10 Platinum Coil Systems due to possible missing implant coils. Affected units have specific reference numbers and lot codes. Consumers should check their product details.
The devices may be missing the implant coil.
Microvention is recalling specific models of endovascular embolization coils because they may be missing the implant coil. This could lead to improper treatment of vascular issues like aneurysms. Affected products have unique reference and lot numbers.
The coils may be missing the implant coil during manufacturing, which could cause improper vascular occlusion. This might lead to incomplete treatment of aneurysms or vascular malformations.
Patients undergoing endovascular procedures for vascular issues like aneurysms or malformations may own these coils. Medical professionals using the product for treatment are most at risk.
Check the product label for reference numbers starting with 100206HCSR-S-V, 100208HC-S-V, 100208HCSR-S-V, 100306HCSR-S-V, 100308HCSR-S-V, 100310HC-S-V, or 100310HCSR-S-V, 100410HC-S-V, or 100410HCSR-S-V. The lot numbers listed in the recall are specific combinations of numbers.
Look for reference numbers starting with 100206HCSR-S-V, 100208HC-S-V, 100208HCSR-S-V, 100306HCSR-S-V, 100308HCSR-S-V, 100310HC-S-V, 100310HCSR-S-V, 100410HC-S-V, or 100410HCSR-S-V.
The devices may be missing the implant coil, which could lead to improper treatment of vascular issues like aneurysms.
Check the product label for reference numbers starting with 100206HCSR-S-V, 100208HC-S-V, 100208HCSR-S-V, 100306HCSR-S-V, 100308HCSR-S-V, 100310HC-S-V, 100310HCSR-S-V, 100410HC-S-V, or 100410HCSR-S-V.
The recall does not specify a remedy, so no action is required beyond checking if your product 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-1395-2020 — Microvention Microvention Hello, I own a Microvention that is covered by recall Z-1395-2020 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.
