FDA Device recall Z-2188-2025
LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200
- FDA Device
- Class II
- ongoing
- Published 2025-08-06
On 2025-08-06 the FDA classified a Class II recall of LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200 by Microvention, citing 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-target….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2188-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-29 |
| Published | 2025-08-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Microvention |
| Distribution | GA |
Product
LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
Reason
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.
Identifiers
| code_info | REF/GTIN/Lot: 8LP2S20/(01)00812636020105/0000177644, 0000180340, 0000223990, 0000235256, 0000254143, 0000254142, 000027…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2188-2025%22
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