CLASS II ONGOING Device recall · Reported 3 Sep 2025 · FDA Enforcement Report
PrisMax V2-US, Hemodialysis Delivery System recalled
Vantive US Healthcare is recalling PrisMax V2-US, Hemodialysis Delivery System. The recall was initiated on 28 Jul 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2437-2025
- FDA event ID
- 97233
- Recalling firm
- Vantive US Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Jul 2025
- FDA classified
- 26 Aug 2025
- Reported
- 3 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 28 Jul 2025 | Recall initiated by company | |
| 26 Aug 2025 | Classified by FDA | +29 days |
| 3 Sep 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
Where it was distributed
Worldwide
Questions about this recall
Why was it recalled?
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
Which lots are affected?
UDI 00085412639499, All Serial Numbers
Where was it sold?
Worldwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 97233| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | TherMax Blood Warmer Unit-US, PrisMax Accessory recalled | Vantive US Healthcare | Device Malfunction | IL | |
| CLASS II | PrisMax V3 control Unit-US, Hemodialysis Delivery System recalled | Vantive US Healthcare | Packaging Defects | IL |
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|---|---|---|---|---|---|
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