LIFEPEARL Drug Elutable Microspheres Recalled for Below-Specification Diameter
MICROVENTION INC. is recalling LIFEPEARL Drug Elutable Microspheres because their actual diameter is smaller than specified. This may prevent proper targeted delivery and treatment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device with a manufacturing defect affecting dimensional specifications. No illnesses or injuries have been reported in the source material. However, the defect presents a clear risk of incomplete or misdirected drug delivery in vascular interventions. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, scoring High (3).
Plain-English summary
MICROVENTION INC. is recalling LIFEPEARL Drug Elutable Microspheres, which are used in vascular embolization procedures to deliver drugs to targeted blood vessels. The affected products include two sizes: 200 micrometers (REF 8LP2S200) and 400 micrometers (REF 8LP2S400). A total of 1,451 units have been distributed outside the United States across 31 countries including Italy, Spain, France, Germany, United Kingdom, and others.
The microspheres have an actual average diameter that is smaller than the specification. This dimensional defect may prevent them from reaching the intended treatment location, resulting in non-targeted embolization or blockage of unintended blood vessels.
Patients with these devices may experience incomplete embolization, inability to receive proper treatment, blockage of non-target vessels, increased procedure time, or need for additional treatment procedures.
Patients who received these devices should contact their healthcare provider if they have concerns. Healthcare providers should discontinue use of the recalled lots and consider whether patients may have received affected products.
The recalled product
- Product
- LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
- Manufacturer
- MICROVENTION INC.
- Hazard
- dimensional-defect
- embolization-failure
- off-target-vessel-blockage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
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