Ivenix Infusion System SET-0032-1Recalls & reported problems
Fresenius Kabi AG · LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 1) · Class 2
All models of Ivenix Infusion System (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Ivenix infusion administration set has 428 reports, including 5 injuries and no deaths. Most reports describe leaks and breaks in the tubing, and some describe it coming loose at connection points. 1 report describes an active infusion that was not stopped after the set broke. 2 open recalls: one for incorrect assembly of a specific lot that could cause serious patient injury, and one for possible leaks from the external cassette.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 396
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 396 adverse event reports that list this exact device (DI 00811505030214), received between Sep 25, 2024 and Sep 28, 2026 — classified as 6 injuries, 390 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (211 reports).
2 FDA recall records name this device's identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Nov 3, 2025Class IOpen, Classified
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Z-0586-2026 · Root cause: Process control · Recall details · FDA record ↗
- Jun 24, 2025Class IIOpen, Classified
Potential for external cassette leaks
Z-2235-2025 · Root cause: Process design · Recall details · FDA record ↗
Most reported problems
Device problems
- No Apparent Adverse Event387
- Leak/Splash211
- Break128
- Obstruction of Flow12
- Incomplete or Inadequate Connection8
- Component Missing6
- Air/Gas in Device5
- Backflow5
Patient problems
- No Clinical Signs, Symptoms or Conditions385
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
- Eye Irritation1
- Hemorrhage/Blood Loss/Bleeding1
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 25 most recent of 396 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Leak/Splash; No Apparent Adverse Event; Incomplete or Inadequate Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915527 ↗MalfunctionSep 28, 2026Leak/Splash; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915526 ↗MalfunctionSep 28, 2026Leak/Splash; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915524 ↗InjurySep 22, 2026Component Missing; No Apparent Adverse Event
The following has been reported:Biomed Reported: cassette missing metal piecesA preliminary review identified the following issue: Missing gold foil An active infusion was not stopped. Reporting as a conservative measure. No adverse effects were reported.Additional information is needed to complete the investigation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856434 ↗MalfunctionSep 14, 2026Backflow; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763606 ↗MalfunctionSep 14, 2026Infusion or Flow Problem; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763604 ↗MalfunctionSep 14, 2026Fluid/Blood Leak
When putting cassette into the pump it was noted that the cassette was leaking out of the pump onto the floor.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754638 ↗MalfunctionSep 14, 2026Air/Gas in Device
Medication continued to get air bubbles in the cassette and require constant removal of cassette and manipulation to try and get bubbles out. This 30 minute infusion took 50 minutes.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50754098 ↗MalfunctionSep 11, 2026Leak/Splash; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50732471 ↗MalfunctionSep 11, 2026Leak/Splash; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50732470 ↗MalfunctionSep 11, 2026Leak/Splash; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50732469 ↗MalfunctionSep 11, 2026Leak/Splash; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50732468 ↗MalfunctionSep 10, 2026Break; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722403 ↗MalfunctionSep 10, 2026Break; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722402 ↗MalfunctionSep 10, 2026Leak/Splash; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722401 ↗MalfunctionSep 10, 2026Leak/Splash; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722375 ↗MalfunctionSep 10, 2026Break; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722373 ↗MalfunctionSep 9, 2026Break; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699118 ↗MalfunctionSep 9, 2026Break; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699115 ↗MalfunctionAug 26, 2026Leak/Splash; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50454476 ↗MalfunctionAug 20, 2026Leak/Splash; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50355514 ↗MalfunctionAug 20, 2026Obstruction of Flow; No Apparent Adverse Event
An Infusion set up and off label use was reported. No patient harm was reported. No samples or pictures were returned for evaluation. The device was not returned to the service depot for further evaluation and possible repair. The following is the list of service activities: The Customer reported an Alarm, Occlusion Alarm, and an Upstream occlusion alarm, The Customer reported some upstream occlusion events experienced during attempted Lutathera (radiopharmaceutical) infusions with the Ivenix Infusion System that appear to be related to infusion setup and off-label use, The Lutathera IFU provides administration instructions only for use with a syringe pump and a peristaltic pump, As the Ivenix LVP is a cassette-driven pump that uses Ivenix administration sets, its use appears to fall outside the administration methods described in the Lutathera IFU. The investigation results could not confirm the complaint as no product was returned; therefore, the complaint could not be confirmed or refuted.The root cause of the reported issue, Infusion set up and off label use, could not be determined. An internal investigation was opened to address this issue. A history review of the Fresenius K
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50351813 ↗InjuryAug 20, 2026Leak/Splash; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50351421 ↗MalfunctionAug 20, 2026Leak/Splash; No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50351418 ↗MalfunctionAug 20, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50351415 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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