Vantive US Healthcare (formerly part of Baxter) has recalled 14,653 units of the PrisMax V2, PrisMax V3, and TherMax Blood Warmer systems. These medical devices are used to provide continuous hemodialysis treatment to patients. The recall was initiated because multiple software and sensor issues can cause false alarms, such as incorrect reports of air in the lines or blood leaks, which can lead to interrupted therapy or repeated setup cycles. Additionally, the TherMax system may fail to detect the blood warming bag, making it difficult to start therapy.
Frequent false alarms and sensor failures can cause significant delays or interruptions in life-sustaining dialysis treatment. These delays may require additional clinical interventions or put patients at risk of inadequate treatment if therapy cannot be restarted promptly.
Firm initiated recall via letter notification.
Quantity: 4772 units
Quantity: 2449 units
Quantity: 7432 units
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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