Reported Aug 6, 2025 · Ongoing
LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
Microvention Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MICROVENTION INC. · 35 Enterprise · Aliso Viejo, CA · 92656
Is this the product you have?
- LIFEPEARL Drug Elutable Microspheres200 +/- 50 micrometers
- REF
8LP2S200400 +/- 50 micrometers
- REF8LP2S400
- Lot codes and dates
2 of 2 products · 20 lot codes
Recalled lot codes, grouped by product number REF GTIN / Lot 8LP2S20(01)00812636020105/000017764400001803400000223990000023525600002541430000254142000027231500002723160000281719000029436100002957410000296446000075166200007516610001026153
8LP2S400(01)00812636020112/00001998690000225205000070850600008630010001026156
- Amount recalled
- 1451
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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