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Open, Classified

LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400

FDA Recall Z-2188-2025 · Posted 2025-07-28

Recalling FirmMICROVENTION INC.
Recall StatusOpen, Classified
Product CodeKRD
Date Initiated2025-05-29
Product Quantity1451

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.

Firm 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: [email protected] 3) If your institution has affected inventory call firm's Customer Care at 800-888-3786 or email [email protected] Please direct questions to the firm at [email protected]

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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