Recall Z-2188-2025— MICROVENTION INC.
Class II · Ongoing
Class II FDA medical device recall by MICROVENTION INC., initiated 2025-05-29. It names one FDA 510(k) clearance: K150958. 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..
- Recalling firm
- MICROVENTION INC.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-05-29
- Firm location
- Aliso Viejo, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.