Approximately 6 units of the Ivenix Infusion System (IIS) using LVP software version 5.2.1 or 5.2.2 were recalled due to two critical software defects. One defect causes an incorrect alarm that stops the pump during startup, potentially delaying necessary medical therapy, while the other fails to alert clinicians when a medication bolus exceeds safety limits, which could lead to a patient receiving too much medication. All affected units were corrected with a software update to version 5.8.0 between May and August 2023.
The software failure could lead to life-threatening over-infusion if high-dose medication is delivered without safety alerts, or severe therapy delays if the pump fails to start properly due to an incorrect 'Fail-Stop' alarm.
Software Update
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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