Vantive US Healthcare LLC
3 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (3)
Registered facilities (16)
- Vantive US Healthcare LLC FEI 2314912 · AR
- Vantive US Healthcare LLC FEI 3038195011 · IL
- VANTIVE HEALTHCARE TECHNOLOGIES PRIVATE LIMITED FEI 3032828299 · IN
- Gambro UF Solutions LLC FEI 3003504604 · MN
- GAMBRO DASCO S.P.A., BLOOD LINE DIVISION FEI 3012394756 · IT
- GAMBRO DASCO S.P.A., MONITORS DIVISION FEI 3002807196 · IT
- BAXTER S.A. DE C.V. FEI 6898 · MX
- GAMBRO RENAL PRODUCTS S.A. DE C.V. FEI 3002806727 · MX
- Vantive Health GmbH FEI 3033903155 · CH
- GAMBRO DIALYSATOREN GMBH FEI 3002807035 · DE
- Vantive Manufacturing Limited FEI 405 · IE
- GAMBRO INDUSTRIES FEI 3002807204 · FR
- Vantive Manufacturing Limited FEI 3002806471 · IE
- Bieffe Medital Manufacturing Oued Ellil Tunisia FEI 3006755813 · TN
- Vantive Manufacturing Pte. Ltd. FEI 3002806460 · SG
- Bieffe Medital S.p.A. FEI 3003591774 · IT
Recalls & enforcement
- Class IIOngoing2026-01-06There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- Class IIOngoing2025-08-28Vantive 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 thin…
- Class IIOngoing2025-07-28Thermax 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
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “Vantive US Healthcare LLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9038727-vantive-us-healthcare-llc/
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