Z-2188-2025Class II

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

Name: Z-2188-2025 LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF...
Creator: Microvention Inc.
Published: 2025-05-29
License: https://open.fda.gov/license/

Terumo Cardiovascular Systems Corporation / initiated 2025-05-29 / Open, Classified / root cause: design

FDA source

MICROVENTION INC. began a recall of LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400 on 2025-05-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2188-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-29
Posted: 2025-07-28
Recalling firm: Terumo Cardiovascular Systems Corporation
Product: LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
Product code: KRD Device, Vascular, For Promoting Embolization
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.
Root cause tag: design
FDA 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: [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]
Quantity in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2188-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2188-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-28

Product code KRD

K150958Class IILifePearl MicroshperesMicroVention, Inc. / cleared 2015-09-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)