Microvention recalls LIFEPEARL Drug Elutable Microspheres (200/400 micrometers) due to potential inability to reach target treatment areas, requiring additional procedures. Affected units have specific reference numbers.
Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targeted embolization), additional procedure/treatment required, blockage other than target vessel, increased procedure time, incomplete embolization, and/or inability to treat the patient.
Microvention is recalling LIFEPEARL Drug Elutable Microspheres that may not reach the intended treatment location, causing ineffective treatment or needing extra procedures. This affects patients who received the specific product sizes and reference numbers listed.
The microspheres have a smaller average diameter than specified, which may prevent them from reaching the intended treatment area. This can lead to incomplete treatment, blockages in unintended vessels, or requiring additional procedures to correct the issue.
Patients who received the recalled LIFEPEARL Drug Elutable Microspheres (200 +/- 50 micrometers, REF: 8LP2S200 or 400 +/- 50 micrometers, REF: 8LP2S400) during procedures. Those with the specific reference numbers listed are most at risk.
Check for the reference numbers listed in the recall: 8LP2S200 or 8LP2S400 with specific lot numbers like 0000177644, 0000180340, etc. The product is used in medical procedures for targeted treatment.
Identify the reference number on your product (e.g., 8LP2S200 or 8LP2S400) and compare it to the list of affected lots provided in the recall.
The microspheres may have a smaller average diameter than specified, which could prevent them from reaching the intended treatment area, leading to ineffective treatment or needing additional procedures.
Check the reference number on your product against the list of affected lots provided in the recall. If it matches, contact Microvention for further instructions.
The recall addresses potential treatment inefficiency, not direct injury risks. The hazard does not include risks of death or serious injury in normal use.
We’ve drafted a message you can send Microvention to request your refund or repair — edit it as you like.
Subject: Recall Z-2188-2025 — Microvention Microvention Hello, I own a Microvention that is covered by recall Z-2188-2025 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.
