Lower risk Medical device recall · FDA · Published May 29, 2025

Microvention LIFEPEARL Drug Elutable Microspheres Recall: Risk of Ineffective Treatment

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2188-2025Medical device Microvention ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmMICROVENTION INC.35 Enterprise · Aliso Viejo, CA 92656

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/52185-microvention-lifepearl-drug-elutable-microspheres-recall-risk-of-ineffective-treatment.

Source Summary by GovInfoNow · govinfonow.com/recall/52185-microvention-lifepearl-drug-elutable-microspheres-recall-risk-of-ineffective-treatment · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2188-2025

Cite this page

“Microvention LIFEPEARL Drug Elutable Microspheres Recall: Risk of Ineffective Treatment.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52185-microvention-lifepearl-drug-elutable-microspheres-recall-risk-of-ineffective-treatment. Based on FDA recall #Z-2188-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2188-2025%22&limit=1).

The FDA announced on May 29, 2025, that Microvention Inc. is recalling LIFEPEARL Drug Elutable Microspheres because their actual average diameter may not meet specifications. The agency said the defect could lead to inability to reach the desired treatment location or require additional procedures.

How to tell if you have it

LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200
LIFEPEARL Drug Elutable Microspheres: 400 +/- 50 micrometers, REF: 8LP2S400
UPC 00812636020105
UPC 00812636020112

The hazard

According to the FDA, the Drug Elutable Microspheres have a smaller actual average diameter that is not within specification. This 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.

Context

GovInfoNow's records show Microvention Inc. has 15 other recalls on record since 2017-08-07. Other recent recalls of similar products include Microvention Bobby Balloon Guide Catheter Recall (2026-04-30), Microvention LVIS Stent Device Recall (2026-04-06), and Microvention Flow Re-Direction Devices (2025-09-05). Other recent recalls of similar products include Micro Therapeutics Pipeline Flex Embolization Device (2026-06-08), Medline Medical Kits Recall (2026-03-24), and Medline Spinal Kits Contain Problematic Bupivacaine Injection - Recall (2026-04-10).

How to tell if you have this one

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.

Brand
Microvention
Product
LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Reference
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.

How this recall unfolded

Recall timeline

FDA published this recall 2 months after the firm started it.

May 29, 2025Firm started the recall
Jul 28, 2025FDA classified it Class II
Aug 6, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is there a risk of serious injury from this product?

The recall addresses potential treatment inefficiency, not direct injury risks. The hazard does not include risks of death or serious injury in normal use.

Similar recalls

Latest medical device recalls

Keep exploring

More Microvention recalls

Link to this recall

<a href="https://govinfonow.com/recall/52185-microvention-lifepearl-drug-elutable-microspheres-recall-risk-of-ineffective-treatment">Microvention LIFEPEARL Drug Elutable Microspheres Recall: Risk of Ineffective Treatment (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-2188-2025 (May 29, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2188-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.