LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers — Class II medical device recall Z-2188-2025
Ongoing recall by MICROVENTION INC., reported 2025-08-06, distributed in GA. Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may
| Recall number | Z-2188-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MICROVENTION INC., Aliso Viejo, CA, United States |
| Recall initiated | 2025-05-29 |
| Classified | 2025-07-28 |
| Reported by FDA | 2025-08-06 |
| Distributed | GA |
| Countries outside the US | BE, CH, CL, CZ, DE, DK, ES, FR, GB, GR, HK, HR, IN, IT, KW, LT, MX, NL, NO, PL, PT, RO, RS, SA, SK, TR, TW, VN |
| Quantity | 1,451 |
| UPC / GTIN / UDI-DI | 00812636020105, 00812636020112 |
| Lot numbers | 8LP2S20 |
| Model numbers | 8LP2S200, 8LP2S400 |
Product
LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2188-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.