InfusomatRecalls & reported problems across all models

We found 54 models of Infusomat by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 2,783 adverse event reports in the FDA's MAUDE database, received between Nov 18, 2016 and Sep 29, 2026 — classified as 38 deaths, 97 injuries, 2,648 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (884 reports).

30 FDA recall records name at least one of these models by its device identifier, 30 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

Infusomat 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. Oct 29, 2025Open, Classified

   Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

   Z-0640-2026 · Root cause: Process control · names 32 of these models · Recall details · FDA record ↗

2. Aug 7, 2024Open, Classified

   Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostatic charge during operation triggering false downstream and upstream occlusion alarms. Additional devices have been affected.

   Z-2972-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

3. Jun 17, 2024Open, Classified

   Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

   Z-2403-2024 · Root cause: Process control · Recall details · FDA record ↗

4. Jun 17, 2024Open, Classified

   Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

   Z-2401-2024 · Root cause: Process control · Recall details · FDA record ↗

5. Jun 17, 2024Open, Classified

   Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

   Z-2400-2024 · Root cause: Process control · Recall details · FDA record ↗

6. Jun 17, 2024Open, Classified

   Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

   Z-2399-2024 · Root cause: Process control · Recall details · FDA record ↗

7. Jun 17, 2024Open, Classified

   Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

   Z-2398-2024 · Root cause: Process control · Recall details · FDA record ↗

8. Jun 17, 2024Open, Classified

   Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

   Z-2397-2024 · Root cause: Process control · Recall details · FDA record ↗

9. Jun 17, 2024Open, Classified

   Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

   Z-2396-2024 · Root cause: Process control · Recall details · FDA record ↗

10. Jun 17, 2024Open, Classified

    Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

    Z-2395-2024 · Root cause: Process control · Recall details · FDA record ↗

11. Jun 17, 2024Open, Classified

    Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

    Z-2394-2024 · Root cause: Process control · Recall details · FDA record ↗

12. Jun 17, 2024Open, Classified

    Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

    Z-2393-2024 · Root cause: Process control · Recall details · FDA record ↗

13. Jun 17, 2024Open, Classified

    Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

    Z-2392-2024 · Root cause: Process control · Recall details · FDA record ↗

14. Jun 17, 2024Open, Classified

    Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

    Z-2391-2024 · Root cause: Process control · Recall details · FDA record ↗

15. Jun 17, 2024Open, Classified

    Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

    Z-2390-2024 · Root cause: Process control · Recall details · FDA record ↗

16. Jun 17, 2024Open, Classified

    Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

    Z-2389-2024 · Root cause: Process control · Recall details · FDA record ↗

17. Jun 17, 2024Open, Classified

    Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

    Z-2388-2024 · Root cause: Process control · Recall details · FDA record ↗

18. Jun 17, 2024Open, Classified

    Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

    Z-2387-2024 · Root cause: Process control · Recall details · FDA record ↗

19. Jun 17, 2024Open, Classified

    Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

    Z-2386-2024 · Root cause: Process control · Recall details · FDA record ↗

20. Jun 17, 2024Open, Classified

    Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

    Z-2385-2024 · Root cause: Process control · Recall details · FDA record ↗

21. Jun 17, 2024Open, Classified

    Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

    Z-2384-2024 · Root cause: Process control · Recall details · FDA record ↗

22. Jun 17, 2024Open, Classified

    Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

    Z-2383-2024 · Root cause: Process control · Recall details · FDA record ↗

23. Jun 17, 2024Open, Classified

    Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

    Z-2382-2024 · Root cause: Process control · Recall details · FDA record ↗

24. Jun 17, 2024Open, Classified

    Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

    Z-2381-2024 · Root cause: Process control · Recall details · FDA record ↗

25. Jun 17, 2024Open, Classified

    Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

    Z-2380-2024 · Root cause: Process control · Recall details · FDA record ↗

26. Jun 17, 2024Open, Classified

    Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

    Z-2379-2024 · Root cause: Process control · Recall details · FDA record ↗

27. Jun 17, 2024Open, Classified

    Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

    Z-2378-2024 · Root cause: Process control · Recall details · FDA record ↗

28. Nov 1, 2023Open, Classified

    In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interruptions or delays in medication administration may result in serious injury to patients which may be life-threatening (e.g. interruption of a vasopressor to a hemodynamically unstable patient) or may lead to death.

    Z-0355-2024 · Root cause: Process control · names 41 of these models · Recall details · FDA record ↗

29. Sep 21, 2023Open, Classified

    Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions. In some cases, this may be life-threatening or may lead to death.

    Z-0124-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

30. Sep 21, 2023Open, Classified

    Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. Interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions. In some cases, this may be life-threatening or may lead to death.

    Z-0123-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported Infusomat problems

Infusomat models

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

• Infusomat® 8713051U

  Pump, infusion
  1 recall28 deaths531 reports
• Infusomat® 490100

  Set, administration, intravascular
  3 recalls2 deaths408 reports
• Infusomat® 490102

  Set, administration, intravascular
  3 recalls3 deaths349 reports
• Infusomat® 363430

  Set, administration, intravascular
  3 recalls245 reports
• Infusomat® 490105

  Set, administration, intravascular
  2 recalls174 reports
• Infusomat® 490103

  Set, administration, intravascular
  3 recalls108 reports
• Infusomat® 363421

  Set, administration, intravascular
  3 recalls86 reports
• Infusomat® 363419

  Set, administration, intravascular
  2 recalls109 reports
• Infusomat® 362035

  Set, administration, intravascular
  1 recall154 reports
• Infusomat® 8713050U

  Pump, infusion
  1 recall2 deaths136 reports
• Infusomat® 362420

  Set, administration, intravascular
  3 recalls29 reports
• Infusomat® 363420

  Set, administration, intravascular
  3 recalls29 reports
• Infusomat® 363904

  Set, administration, intravascular
  1 recall116 reports
• Infusomat® 490101

  Set, administration, intravascular
  3 recalls13 reports
• Infusomat® 363230

  Set, administration, intravascular
  3 recalls7 reports
• Infusomat® 363423

  Set, administration, intravascular
  3 recalls5 reports
• Infusomat® 363424

  Set, administration, intravascular
  3 recalls4 reports
• Infusomat® 480254

  Set, administration, intravascular
  3 recalls3 reports
• Infusomat® 490104

  Set, administration, intravascular
  3 recalls3 reports
• Infusomat® 362033

  Set, administration, intravascular
  3 recalls3 reports
• Infusomat® 362050

  Set, administration, intravascular
  3 recalls1 report
• Infusomat® 363010

  Set, administration, intravascular
  3 recalls1 report
• Infusomat® 480255

  Set, administration, intravascular
  3 recalls0 reports
• Infusomat® 480263

  Set, administration, intravascular
  3 recalls0 reports
• Infusomat® 362032

  Set, administration, intravascular
  3 recalls0 reports
• Infusomat® 362034

  Set, administration, intravascular
  3 recalls0 reports
• Infusomat® 362432

  Set, administration, intravascular
  3 recalls0 reports
• Infusomat® 363030

  Set, administration, intravascular
  3 recalls0 reports
• Infusomat® 363422

  Set, administration, intravascular
  3 recalls0 reports
• Infusomat® 363433

  Set, administration, intravascular
  3 recalls0 reports
• Infusomat® 8713052U

  Pump, infusion
  1 recall3 deaths94 reports
• Infusomat® 490037

  Set, administration, intravascular
  1 recall71 reports
• Infusomat® 480258

  Set, administration, intravascular
  2 recalls6 reports
• Infusomat® 363019

  Set, administration, intravascular
  2 recalls2 reports
• Infusomat® 362431

  Set, administration, intravascular
  2 recalls1 report
• Infusomat® 362043

  Set, administration, intravascular
  2 recalls0 reports
• Infusomat® 480264

  Set, administration, intravascular
  1 recall35 reports
• Infusomat® 363032

  Set, administration, intravascular
  1 recall11 reports
• Infusomat® 480257

  Set, administration, intravascular
  1 recall8 reports
• Infusomat® 363902

  Set, administration, intravascular
  1 recall8 reports
• Infusomat® 490038

  Set, administration, intravascular
  1 recall3 reports
• Infusomat® 470119

  Set, administration, intravascular
  1 recall3 reports
• Infusomat® 363410

  Set, administration, intravascular
  1 recall2 reports
• Infusomat® 490655

  Set, administration, intravascular
  1 recall1 report
• Infusomat® 362911

  Set, administration, intravascular
  1 recall1 report
• Infusomat® 480256

  Set, administration, intravascular
  1 recall0 reports
• Infusomat® 363901

  Set, administration, intravascular
  1 recall0 reports
• Infusomat® 362004

  Set, administration, intravascular
  6 reports
• Infusomat® 363220

  Set, administration, intravascular
  6 reports
• Infusomat® 8713060U

  Pump, infusion
  3 reports
• Infusomat® 490036

  Set, administration, intravascular
  3 reports
• Infusomat® 363219

  Set, administration, intravascular
  3 reports
• Infusomat® 490041

  Set, administration, intravascular
  1 report
• Infusomat® 363232

  Set, administration, intravascular
  1 report

Recent Infusomat adverse event reports

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

• MalfunctionSep 29, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937115 ↗
• MalfunctionSep 29, 2026Leak/Splash

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50927922 ↗
• MalfunctionSep 25, 2026Free or Unrestricted Flow

  As reported by the user facility:Details of complaint (Reported Issue): "Although the wheel of the 0.9% NaCl tubing was completely closed, the blood flowed back up to the 0.9% NaCl sac. The patient received approximately 50 mL of 0.9% NaCl. It appears that the wheel does not allow complete occlusion of the tubing."No injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896572 ↗
• MalfunctionSep 25, 2026Fail-Safe Did Not Operate

  As reported by the user facility: Failed to detect air bubble when used on patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896171 ↗
• MalfunctionSep 23, 2026Leak/Splash

  As reported by the user facility: We seem to have had some more tubing issues lately with both the primary tubing and the tubing we use for Taxol infusions. Pharmacy has had to reprime a few Taxols during the infusion well after infusion has been running. The issues with the primary tubing seem to be random, different lot numbers and different issues. A lot of high-pressure alarms for no reason or accumulated air alarm, even a leaky y-site here and there.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870312 ↗
• MalfunctionSep 23, 2026Air/Gas in Device

  As reported by the user facility:Air in line during use. No injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870264 ↗
• MalfunctionSep 23, 2026Air/Gas in Device

  As reported by the user facility:Air in line during use. No injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870193 ↗
• MalfunctionSep 23, 2026Leak/Splash

  As reported by the user facility:30 minutes after etoposide was started RN went into the patient's room and noticed a wet spot underneath the tubing where the chemo was infusing through. The etoposide was running into the Y-site of the fluid line (through equashield) closest to the patient. The leak was at this connection point, despite all connection points with the equashield being tightened all the way. Chemo line disconnected from the fluid line and was reconnected directly to the patient to finish the infusion. The spill did not touch the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867042 ↗
• MalfunctionSep 23, 2026Air/Gas in Device

  As reported by the user facility:Air in line during use. No injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867040 ↗
• MalfunctionSep 23, 2026Air/Gas in Device

  As reported by the user facility:Air in line during use. No injury reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867036 ↗
• MalfunctionSep 16, 2026Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791879 ↗
• MalfunctionSep 16, 2026Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791878 ↗
• MalfunctionSep 16, 2026Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791877 ↗
• MalfunctionSep 15, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777880 ↗
• MalfunctionSep 15, 2026Leak/Splash

  As reported by the user facility:The customer has experienced the vent caps from the drip chamber falling off while the nurse was attempting to vent the tubing. This resulted in chemotherapy spilling from the tubing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775190 ↗

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