LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
FDA device recall Z-2188-2025 · posted 2025-07-28 · Open, Classified
Recall details
- Recalling firm
- MICROVENTION INC.
- 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.
- Action taken
- On 5/29/2025, recall notices were mailed and emailed to customers who were asked to do the following: 1) Inform all individuals within your organization of the recall and forward the recall notice to any organizations that may have received the affected products. 2) Complete and return the customer acknowledgement form via email: recalls@microvention.com 3) If your institution has affected inventory call firm's Customer Care at 800-888-3786 or email tmccustomer.admin@terumomedical.com Please direct questions to the firm at MVEMEAQARA@microvention.com
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- KRD
- Quantity affected
- 1451
- Distribution
- OUS: Italy, Spain, Portugal, Poland, Belgium, Germany, Denmark, France, Kazakhstan, Slovakia, Norway, Greece, Serbia, Turkey, Czech Republic, United Kingdom, Netherlands, Russian Federation, Kuwait, R
- Date initiated
- 2025-05-29
- Date posted
- 2025-07-28
- Location
- Aliso Viejo, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LifePearl Microshperes (K150958) | MicroVention, Inc. | 2015-09-17 |