LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
Summary
The FDA issued a Class II for LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 by MICROVENTION INC.. Reason: Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired t.
Details
Source
Device Recall
External ID
Z-2188-2025
Action Date
2025-08-06
Status
Ongoing
Category
device
Product Description
LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
Lot/Code Info: REF/GTIN/Lot: 8LP2S20/(01)00812636020105/0000177644, 0000180340, 0000223990, 0000235256, 0000254143, 0000254142, 0000272315, 0000272316, 0000281719, 0000294361, 0000295741, 0000296446, 0000751662, 0000751661, 0001026153; 8LP2S400/(01)00812636020112/0000199869, 0000225205, 0000708506, 0000863001, 0001026156
Quantity Affected: 1451
Reason for 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.
Distribution
OUS: Italy, Spain, Portugal, Poland, Belgium, Germany, Denmark, France, Kazakhstan, Slovakia, Norway, Greece, Serbia, Turkey, Czech Republic, United Kingdom, Netherlands, Russian Federation, Kuwait, Republic of North Macedonia, Switzerland, Saudi Arabia, Georgia, Lithuania, Romania, Croatia, Chile, Hong Kong , India, Mexico, Taiwan, Vietnam
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-29
Company
Aliso Viejo, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 157 device recalls issued in the same week, part of 403 device-related FDA actions this month.
MICROVENTION INC. has 18 FDA actions in our database, including 11 recalls and 7 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MICROVENTION INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MICROVENTION INC. have FDA actions?
MICROVENTION INC. has 18 FDA actions in our database, including 11 recalls and 7 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2188-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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