LIFEPEARL microspheres are smaller than specification, risking non-targeted embolization

Plain-English summary

LIFEPEARL Drug Elutable Microspheres, 200 ± 50 micrometres (REF 8LP2S200) and 400 ± 50 micrometres (REF 8LP2S400), are being recalled. The action covers 1,451 units across the lot numbers listed in the recall notice.

According to the manufacturer, the microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location, meaning non-targeted embolization, as well as additional procedure or treatment being required, blockage of a vessel other than the target, increased procedure time and incomplete embolization. The FDA classified the action as Class II. The source does not report any injury having occurred.

Distribution was outside the United States, to Italy, Spain, Portugal, Poland, Belgium, Germany, Denmark, France and Kazakhstan among other countries.

Facilities should identify affected stock using the REF, GTIN and lot numbers in the recall notice and follow the instructions issued by the manufacturer.

The recalled product

Product

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

Manufacturer

MICROVENTION INC.

Category

Medical Device — Embolic microspheres

Hazard

• out-of-specification
• particle-size
• non-targeted-embolization
• class-ii

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distribution scope not specified by the agency.

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