Ivenix, Inc.Recalls & reported problems across all models

We found 4 models of Ivenix, Inc. by Fresenius Kabi AG in the FDA's device registry (GUDID). Together they are named in 211 adverse event reports in the FDA's MAUDE database, received between Jul 3, 2024 and Sep 22, 2026 — classified as 4 injuries, 207 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (70 reports).

15 FDA recall records name at least one of these models by its device identifier, 12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Ivenix, Inc. recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 6, 2026Open, Classified

   Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.

   Z-2223-2026 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗

2. Nov 21, 2025Open, Classified

   Emphasizing instructions for LVP duration programming located in the IFU.

   Z-1048-2026 · Root cause: Use error · Recall details · FDA record ↗

3. Nov 14, 2025Open, Classified

   Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.

   Z-0885-2026 · Root cause: Software design · Recall details · FDA record ↗

4. Jun 24, 2025Open, Classified

   Potential for external cassette leaks

   Z-2234-2025 · Root cause: Process design · Recall details · FDA record ↗

5. Jun 24, 2025Open, Classified

   Potential for external cassette leaks

   Z-2233-2025 · Root cause: Process design · Recall details · FDA record ↗

6. Jun 24, 2025Open, Classified

   Potential for external cassette leaks

   Z-2232-2025 · Root cause: Process design · Recall details · FDA record ↗

7. May 12, 2025Open, Classified

   Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.

   Z-1869-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

8. Jan 10, 2025Open, Classified

   Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.

   Z-1019-2025 · Root cause: Software Design Change · Recall details · FDA record ↗

9. Aug 30, 2024Open, Classified

   The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.

   Z-3153-2024 · Root cause: Software design · Recall details · FDA record ↗

10. Aug 1, 2024Open, Classified

    A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).

    Z-2721-2024 · Root cause: Process control · Recall details · FDA record ↗

11. Mar 7, 2024Open, Classified

    Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.

    Z-1484-2024 · Root cause: Software Design Change · Recall details · FDA record ↗

12. May 10, 2023Completed

    Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) Alert is not annunciated informing the clinician that the bolus cannot be delivered when the entered bolus dose exceeds the Care Profile Hard Rate Max limit and Rapid Bolus is selected. May lead to over infusion. Both issues were resolved in all fielded product in software version 5.8.0, which was installed in affected units May thru August 2023.

    Z-1283-2024 · Root cause: Software design · Recall details · FDA record ↗

13. Sep 16, 2022Completed

    Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable (Fail-Stop) Pump Problem alarm. This may lead to delay of therapy, and patient may experience from no to minimal to serious harm. This issue was resolved in all fielded product in software version 5.2.1, which was installed in September 2022.

    Z-1282-2024 · Root cause: Software design · Recall details · FDA record ↗

14. Sep 8, 2022Terminated

    The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.

    Z-0002-2023 · Root cause: Software design · Recall details · FDA record ↗

15. Apr 22, 2022Open, Classified

    Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set

    Z-2635-2023 · Root cause: Device Design · Recall details · FDA record ↗

Most reported Ivenix, Inc. problems

Ivenix, Inc. models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Ivenix, Inc. 2.0

  Pump, Infusion
  10 recalls0 reports
• Ivenix, Inc. SET-0014-1

  Set, Administration, Intravascular
  2 recalls93 reports
• Ivenix, Inc. SET-0013-1

  Set, Administration, Intravascular
  2 recalls91 reports
• Ivenix, Inc. SET-0021-1

  Set, Administration, Intravascular
  1 recall27 reports

Recent Ivenix, Inc. adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break; No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856433 ↗
• MalfunctionSep 14, 2026Break

  Blood bag tubing broke when getting spiked to be used by nursing staff. Our health system has had 10 of the events reported across multiple sites. Per our lab manager, this is contributing to wasted blood amidst a blood shortage.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754386 ↗
• MalfunctionSep 10, 2026No Apparent Adverse Event; Priming Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722063 ↗
• MalfunctionSep 9, 2026No Apparent Adverse Event; Incomplete or Inadequate Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695354 ↗
• MalfunctionSep 9, 2026No Apparent Adverse Event; Incomplete or Inadequate Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695351 ↗
• MalfunctionSep 9, 2026No Apparent Adverse Event; Incomplete or Inadequate Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695344 ↗
• MalfunctionAug 13, 2026Leak/Splash; No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50236503 ↗
• MalfunctionAug 11, 2026Break; No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50201421 ↗
• InjuryJul 27, 2026No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available

  The following has been reported:Customer reported: patient that needed blood products, went through 5 blood tubing lines, 6 different pumps because the pumps kept staying the line was not able to be read in the pump. A preliminary review identified the following issue: Set Not Recognized.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 50013374 ↗
• MalfunctionJun 17, 2026Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: BLOOD TUBING LEAKED AT RIGHT ABOVE THE CASSETTE. DISCARDED NO PATIENT HARM A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET LEAK (EXTERNAL PART) AN ACTIVE INFUSION WAS 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 25534500 ↗
• MalfunctionJun 15, 2026Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: 3 DIFFERENT ITEMS OF THE SAME LOT # (FA25C03165) LEAKING BLOOD PRODUCT INTO THE PUMP. AS A RESULT, WE WASTED BLOOD PRODUCT. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET LEAK (EXTERNAL PART). UNKNOWN IF AN ACTIVE INFUSION WAS 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 25503712 ↗
• MalfunctionJun 15, 2026Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: 3 DIFFERENT ITEMS OF THE SAME LOT # (FA25C03165) LEAKING BLOOD PRODUCT INTO THE PUMP. AS A RESULT, WE WASTED BLOOD PRODUCT. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET LEAK (EXTERNAL PART). UNKNOWN IF AN ACTIVE INFUSION WAS 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 25503709 ↗
• MalfunctionJun 11, 2026Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: ALARM- TUBING SET PROBLEM A PRELIMINARY REVIEW OF THE DEVICE LOGS WAS NOT PERFORMED. THE ADMINISTRATION SET WAS RETURNED FOR EVALUATION. THE SAMPLE WAS EVALUATED AND UNDERWENT A DETAILED 6M INVESTIGATION. VISUAL EXAMINATION IDENTIFIED A LEAK PATTERN NEAR THE SIDE CASSETTE AREA. HOWEVER, REPEAT FUNCTIONAL TESTING AND CONFIRMATION TESTING COULD NOT REPRODUCE THE REPORTED LEAK CONDITION. THE MANUFACTURING PROCESS, EQUIPMENT PARAMETERS, MATERIALS, AND METHODS WERE REVIEWED AND FOUND TO BE WITHIN VALIDATED SPECIFICATIONS. EXTENDED PRODUCTION DATA AND PROCESS VALIDATION RECORDS CONFIRMED THAT THE CASSETTE WELDING PROCESS REMAINS STABLE AND CAPABLE. BASED ON THE EVALUATION, THE REPORTED LEAK CONDITION AND ALARM IS CONFIRMED. THE INVESTIGATION IDENTIFIED EVIDENCE SUGGESTING A POTENTIAL LOCALIZED INNER CASSETTE LEAK ASSOCIATED WITH OVERHEATED PLASTIC DURING THE ULTRASONIC WELDING PROCESS, THEREFORE TRIGGERING THE TUBING SET PROBLEM ALARM. HOWEVER, REVIEW OF VALIDATED WELDING PARAMETERS, PRODUCTION RECORDS, AND ADDITIONAL PRODUCTION RUNS DEMONSTRATED THAT THE WELDING PROCESS WAS OPERATING WITHIN ESTABLISHED CONTROLS AND THAT NO SYSTEMIC MANUFACTURING ISSUE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25473907 ↗
• MalfunctionMay 27, 2026Leak/Splash; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: ISSUE WITH A BLOOD CASSETTE, IT COMPLETELY STARTED LEAKING THROUGH. NO SAMPLE OR LOT # AVAILABLE. A PRELIMINARY REVIEW IDENTIFIED THE FOLLOWING ISSUE: ADMINISTRATION SET LEAK (EXTERNAL PART) UNKNOWN IF AN ACTIVE INFUSION WAS 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 25306806 ↗
• MalfunctionMay 20, 2026Obstruction of Flow; No Apparent Adverse Event

  THE FOLLOWING HAS BEEN REPORTED: NURSE REPORTED: "RN CALLED CIS TO BEDSIDE FOR ISSUE WITH INFUSING BLOOD. BLOOD SET DESCRIBED TO HAVE BEEN PRIMED APPROPRIATELY VIA BACKPRIME ON THE PUMP. WITNESSED CONTINUOUS UPSTREAM OCCLUSION ALARM. RN ATTEMPTED TO TROUBLESHOOT VIA BACKPRIME WHICH ALSO MAINTAINED CONTINUOUS OCCLUSION. ATTEMPTED TO PRIME BLOOD PRODUCT MANUALLY USING FLOW DIAL (DISCONNECTED FROM PATIENT) AND PRBCS VERY SLOW TO ADVANCE. ATTEMPTED TO INFUSE ON A DIFFERENT PUMP WITH SAME ALARM. CHANGED TO A NEW BLOOD SET AND SUCCESSFULLY PRIMED/INFUSED BLOOD. CONTINUOUS OCCLUSION ALARM. RESOLVED BY CHANGING TO NEW ADMIN SET. DRUG USED: PRBC. PATIENT HARM: NO". AS IT WAS FULL OF A BLOOD PRODUCT IT HAD TO BE DISCARDED. A PRELIMINARY REVIEW OF THE LOGS IDENTIFIED THE FOLLOWING ISSUE: TUBING SET ERROR (CLOGGED ADMIN SET). 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 25233827 ↗

Other Fresenius Kabi AG products

• Ivenix Infusion System5 models · 4,736 reports · 9 recalls
• Volumat Line8 models · 49 reports