VANTIVE US HEALTHCARE LLC recalls PRISMAFLEX M150 SET

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Vantive issued an Urgent Medical Device Correction notice to its consignees on 01/06/2026 via USPS first class mail. The notice explained the issue, hazard involved, and requested the following: 1. You may continue to perform therapy using the Prismaflex sets listed above. Please monitor the deaeration chamber during therapy to ensure it remains in an upright position within the holder. 2. Vantive is aware of customers who have experienced this issue and attempted to further secure the deaeration chamber in an upright position. If attempting to secure the deaeration chamber in an upright position, please consider the following: . Ensure there are no kinks in the tubing and that the deaeration chamber remains visible. . If the Prismaflex Control Unit issues an Air in Blood alarm, check if air is present. If there is no air present, check if the deaeration chamber is dislodged from the holder and ensure there are no clots present. 1. If no dislodgement, please follow the operator s manual instructions for Air in Blood alarm. 2. In case of dislodgement with clotting, follow the associated instructions within the Prismaflex Control Unit operator s manual to stop the therapy and replace the set. 3. Only in case of dislodgement without clotting or any other alarms, if the chamber is secured in an upright position, follow the associated instructions within the Prismaflex Control Unit operator s manual to proceed with treatment. Facilities who further distributed the products were directed to notify those departments or facilities. Dealers, wholesalers, distributor/resellers, or original equipment manufacturers (OEM) who further distributed the products were directed to notify their customers. For general questions regarding this communication, please contact Vantive Customer Care at 833-542-CRRT (2778). Vantive Customer Care is available 24 hours a day, seven days a week.

• FDA enforcement recordOfficial FDA database entry for Z-1228-2026
• FDA 510(k) clearance · K080519The device's official FDA premarket clearance record
• FDA device classification · KDIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.5860The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find VANTIVE US HEALTHCARE LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.