Recall Z-2188-2025 ยท KRD Device, Vascular, For Promoting Embolization
MICROVENTION INC.
LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
| Date | Jul 28, 2025 (initiated May 29, 2025) |
| Status | Open, Classified |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150958 | LifePearl Microshperes MicroVention, Inc., Sep 17, 2015 |