Vantive US Healthcare, LLC
United Statesfrom the FDA registration address FDA FEI 3038195011
- Devices
- 18
- Registrations
- FDA
- FDA recalls
- 1212 ongoing
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
Catalogue
Search and filter all 18 devicesCompany details
- FDA FEI number
- 3038195011
- DUNS number
- 119533513
- Address
- 510 Lake Cook Rd, Deerfield, IL, 60015
- [email protected]
- Phone
- +1(800)284-4060
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 4
- 2026 8
2026
- 6 Jan 2026 Z-1224-2026 Class II Ongoing There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- 6 Jan 2026 Z-1225-2026 Class II Ongoing There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- 6 Jan 2026 Z-1226-2026 Class II Ongoing There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- 6 Jan 2026 Z-1227-2026 Class II Ongoing There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- 6 Jan 2026 Z-1228-2026 Class II Ongoing There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- 6 Jan 2026 Z-1229-2026 Class II Ongoing There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- 6 Jan 2026 Z-1230-2026 Class II Ongoing There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- 6 Jan 2026 Z-1231-2026 Class II Ongoing There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
2025
- 28 Aug 2025 Z-0409-2026 Class II Ongoing Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.
Full distribution text
- 28 Jul 2025 Z-2437-2025 Class II Ongoing 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
- 28 Aug 2025 Z-0409-2026 Class II Ongoing Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.
Show all 12 recalls
2025
- 28 Jul 2025 Z-2438-2025 Class II Ongoing Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Normalization Failed, or T1205: BLD Self-Test Failure
- 28 Jul 2025 Z-2439-2025 Class II Ongoing Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted
Frequently asked questions
How many devices does Vantive US Healthcare, LLC have in the registry?
The registry currently lists 18 devices for Vantive US Healthcare, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vantive US Healthcare, LLC's devices?
Among its 18 most recently registered devices, Vantive US Healthcare, LLC has devices listed in FDA 510(k) (1 device), FDA PMA (1 device) and FDA GUDID (16 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Vantive US Healthcare, LLC's devices fall under?
Among its 18 most recently registered devices, the classes recorded for Vantive US Healthcare, LLC's devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Vantive US Healthcare, LLC?
FDA recall records list 12 recalls initiated by Vantive US Healthcare, LLC, the most recent initiated on 6 Jan 2026. 12 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Vantive US Healthcare, LLC in the registry?
The most recently registered devices listed for Vantive US Healthcare, LLC include Extension Set with EASY-LOCK Connector 5C4480C, Sharesource Connectivity Platform for Use with the Amia APD System 5C9400, UltraSet CAPD Disposable Disconnect Y-Set L5C4366 and 12 Foot Extension Set 5C4464P.