Microvention Inc. is recalling 1,451 units of LIFEPEARL Drug Elutable Microspheres (200 +/- 50 micrometers and 400 +/- 50 micrometers). The actual average diameter of these microspheres is smaller than required specifications. This defect can prevent the device from reaching the correct treatment location or cause the spheres to block unintended blood vessels. No injuries have been reported to date. Hospitals and surgical centers should stop using affected units and arrange for their return to the manufacturer.
The undersized microspheres may pass through the intended treatment site and block other blood vessels (non-targeted embolization). This can lead to procedure failure, the need for additional surgery, damage to healthy tissue, or an inability to properly treat the patient.
Actual average diameter is not within specification.
Actual average diameter is not within specification.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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