FDA Medical Device Recalls (openFDA)
MICROVENTION INC.: LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
- Recall number
- Z-2188-2025
- Recalling firm
- MICROVENTION INC.
- Product
- LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
- Status
- Open, Classified
- Initiated
- 2025-05-29
- Posted
- 2025-07-28
- Terminated
- not on file
- 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.
- Root cause
- Device Design
- Action
- 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
- Quantity
- 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, Republic of North Macedonia, Switzerland, Saudi Arabia, Georgia, Lithuania, Romania, Croatia, Chile, Hong Kong , India, Mexico, Taiwan, Vietnam
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K150958"]
- PMA numbers
- not on file
- Product code
- KRD
- Firm FEI
- 3013556777
- Firm city
- Aliso Viejo
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28