Vantive Healthcare recalls PrisMax V2-US hemodialysis systems with specific product codes due to potential air detection alarms causing extra priming cycles. Affected units may need reevaluation.
Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles
Vantive Healthcare is recalling Pris:Max V2-US hemodialysis systems with product codes 955626, 955558, 955627, and 955701. The recall is due to a risk of air detection alarms that could cause extra priming cycles during dialysis treatment.
The system may show an air detection alarm (T2309) after priming, which can trigger additional priming cycles. This happens when the deaeration chamber level is too low during post-priming tests.
Hemodialysis patients using the PrisMax V2-US system with the listed product codes are affected. Patients using these systems are most at risk of unnecessary priming cycles during treatment.
Check for product codes 955626, 955558, 955627, or 955701 on the PrisMax V2-US hemodialysis system. All units with the UDI 00085412639499 are also affected.
Review the product codes on your PrisMax V2-US system to confirm if it is affected (955626, 955558, 955627, or 955701).
The recall is due to a potential low deaeration chamber level that may cause air detection alarms (T2309), leading to extra priming cycles during dialysis.
Check your product codes to see if you are affected. If you are, contact Vantive Healthcare for further instructions.
The recall record does not mention a specific fix or remedy for this issue.
We’ve drafted a message you can send Vantive Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2437-2025 — Vantive Healthcare Vantive Healthcare Hello, I own a Vantive Healthcare that is covered by recall Z-2437-2025 from Vantive Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
