CADDRecalls & reported problems across all models

We found 123 models of CADD by Icu Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 53,012 adverse event reports in the FDA's MAUDE database, received between Feb 17, 2017 and Sep 30, 2026 — classified as 31 deaths, 232 injuries, 52,748 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (16,163 reports).

21 FDA recall records name at least one of these models by its device identifier, 21 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

CADD 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. Aug 6, 2025Class IIOpen, Classified

   Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

   Z-2526-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Aug 6, 2025Class IIOpen, Classified

   Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

   Z-2525-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Aug 6, 2025Class IIOpen, Classified

   Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

   Z-2524-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Aug 6, 2025Class IIOpen, Classified

   Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

   Z-2523-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. Aug 6, 2025Class IIOpen, Classified

   Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

   Z-2522-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. Apr 10, 2025Class IOpen, Classified

   Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

   Z-1662-2025 · Root cause: Software design · names 9 of these models · Recall details · FDA record ↗

7. Apr 10, 2025Class IOpen, Classified

   There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

   Z-1682-2025 · Root cause: Under Investigation by firm · names 13 of these models · Recall details · FDA record ↗

8. Apr 10, 2025Class IOpen, Classified

   There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

   Z-1681-2025 · Root cause: Under Investigation by firm · names 8 of these models · Recall details · FDA record ↗

9. Apr 10, 2025Class IOpen, Classified

   Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

   Z-1668-2025 · Root cause: Labeling design · names 16 of these models · Recall details · FDA record ↗

10. Apr 10, 2025Class IOpen, Classified

    Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

    Z-1667-2025 · Root cause: Labeling design · names 16 of these models · Recall details · FDA record ↗

11. Jun 26, 2024Class IIOpen, Classified

    Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

    Z-0014-2025 · Root cause: Process control · Recall details · FDA record ↗

12. Jun 26, 2024Class IIOpen, Classified

    Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

    Z-0013-2025 · Root cause: Process control · Recall details · FDA record ↗

13. Jun 26, 2024Class IIOpen, Classified

    Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

    Z-0012-2025 · Root cause: Process control · Recall details · FDA record ↗

14. Jun 26, 2024Class IIOpen, Classified

    Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

    Z-0011-2025 · Root cause: Process control · Recall details · FDA record ↗

15. Feb 27, 2024Class IOpen, Classified

    The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.

    Z-2421-2024 · Root cause: Software Manufacturing/Software Deployment · names 14 of these models · Recall details · FDA record ↗

16. Feb 27, 2024Class IOpen, Classified

    The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.

    Z-2420-2024 · Root cause: Software Manufacturing/Software Deployment · names 18 of these models · Recall details · FDA record ↗

17. Dec 9, 2022Class IOpen, Classified

    There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

    Z-0966-2023 · Root cause: Under Investigation by firm · names 19 of these models · Recall details · FDA record ↗

18. Dec 9, 2022Class IOpen, Classified

    There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

    Z-0965-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

19. Dec 9, 2022Class IOpen, Classified

    There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

    Z-0964-2023 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗

20. Dec 9, 2022Class IOpen, Classified

    There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

    Z-0963-2023 · Root cause: Under Investigation by firm · names 17 of these models · Recall details · FDA record ↗

21. Dec 9, 2022Class IOpen, Classified

    There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

    Z-0962-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported CADD problems

CADD models

123 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.

• CADD 21-6500-51

  Pump, infusion
  2 deaths8,231 reports
• CADD 21-6400-51

  Pump, infusion
  7 deaths7,543 reports
• CADD 21-2120-0105-01

  Pump, infusion
  4 recalls3 deaths5,914 reports
• CADD 21-7302-24

  Set, administration, intravascular
  4 recalls1 death4,657 reports
• CADD 2120

  Pump, infusion
  2 recalls6 deaths4,097 reports
• CADD 21-2120-0102-51

  Pump, infusion
  4 recalls2 deaths3,555 reports
• CADD 21-7411-51

  Pump, infusion
  1 death1,858 reports
• CADD 21-2111-0402-51

  Pump, infusion, pca
  4 recalls1,535 reports
• CADD 21-2127-0105-01

  Pump, infusion
  2 recalls1,466 reports
• CADD 2120

  Pump, infusion
  2 recalls3 deaths1,256 reports
• CADD 21-7106-24

  Set, administration, intravascular
  1,321 reports
• CADD 21-2120-0103-51

  Pump, infusion
  2 recalls1 death1,107 reports
• CADD 21-2111-0300-01

  Pump, infusion, pca
  1 recall1,116 reports
• CADD 21-2120-0103-01

  Pump, infusion
  4 recalls585 reports
• CADD 21-7346-24

  Set, administration, intravascular
  2 recalls634 reports
• CADD 21-7394-24

  Set, administration, intravascular
  2 recalls2 deaths586 reports
• CADD 21-7301-24

  Set, administration, intravascular
  4 recalls467 reports
• CADD 21-2111-0401-51

  ACCESSORIES, PUMP, INFUSION
  4 recalls461 reports
• CADD 21-7308-24

  Set, administration, intravascular
  2 recalls1 death526 reports
• CADD 21-2112-0402-51

  Neuraxial Administration Set - Intrathecal delivery
  3 recalls469 reports
• CADD 21-2120-0102-02

  Pump, infusion
  3 recalls381 reports
• CADD 21-7322-24

  Set, administration, intravascular
  2 recalls391 reports
• CADD 21-2112-0300-01

  Pump, infusion, pca
  1 recall406 reports
• CADD 21-6300-51

  Pump, infusion, pca
  414 reports
• CADD 21-7002-24

  Pump, infusion
  1 recall331 reports
• CADD 21-2111-0400-51

  Pump, infusion
  4 recalls124 reports
• CADD 21-7300-24

  Set, administration, intravascular
  4 recalls121 reports
• CADD 21-2112-0402-51L

  Neuraxial Administration Set - Intrathecal delivery
  3 recalls129 reports
• CADD 21-2111-0402-51L

  Pump, infusion, pca
  3 recalls127 reports
• CADD 21-7047-24

  Set, administration, intravascular
  258 reports
• CADD 21-7324-24

  Set, administration, intravascular
  2 recalls155 reports
• CADD 21-7349-24

  Set, administration, intravascular
  2 recalls135 reports
• CADD 21-7363-24

  Set, administration, intravascular
  1 recall172 reports
• CADD 21-7359-24

  Set, administration, intravascular
  2 recalls110 reports
• CADD 21-2112-0300-00

  Pump, infusion, pca
  4 recalls6 reports
• CADD 2110

  Pump, infusion, pca
  4 recalls4 reports
• CADD 2120

  Pump, infusion
  4 recalls2 reports
• CADD 21-7001-24

  Pump, infusion
  2 recalls100 reports
• CADD 21-2111-0300-231

  Pump, infusion, pca
  4 recalls0 reports
• CADD 2120

  Pump, infusion
  4 recalls0 reports
• CADD 2110

  Pump, infusion, pca
  4 recalls0 reports
• CADD 2120

  Pump, infusion
  4 recalls0 reports
• CADD 21-2120-0105-00

  Pump, infusion
  2 recalls97 reports
• CADD 21-7309-24

  Set, administration, intravascular
  2 recalls80 reports
• CADD 21-7391-24

  Set, administration, intravascular
  2 recalls77 reports
• CADD 21-7361-24

  Set, administration, intravascular
  175 reports
• CADD 21-7343-24

  Set, administration, intravascular
  2 recalls65 reports
• CADD 21-7383-24

  Set, administration, intravascular
  2 recalls63 reports
• CADD 21-2112-0100-51

  Pump, infusion, pca
  2 recalls59 reports
• CADD 21-2111-0402-78

  Neuraxial Administration Set - Intrathecal delivery
  3 recalls5 reports
• CADD 21-2112-0402-78

  ACCESSORIES, PUMP, INFUSION
  3 recalls0 reports
• CADD 21-2112-0401-51

  Pump, infusion, pca
  1 recall97 reports
• CADD 21-7052-24

  Set, administration, intravascular
  141 reports
• CADD 21-7381-24

  Set, administration, intravascular
  135 reports
• CADD 21-7333-24

  Set, administration, intravascular
  2 recalls24 reports
• CADD 21-7310-24

  Set, administration, intravascular
  2 recalls21 reports
• CADD 2120

  Pump, infusion
  2 recalls4 reports
• CADD 2110

  Pump, infusion, pca
  2 recalls1 report
• CADD 21-7649-24

  Administrations sets with neuraxial connectors
  2 recalls0 reports
• CADD 21-7092-24

  Set, administration, intravascular
  96 reports
• CADD 21-7321-24

  Set, administration, intravascular
  1 recall45 reports
• CADD 21-6300-02

  Pump, infusion, pca
  2 deaths90 reports
• CADD 21-2120-0102-78

  Pump, infusion
  1 recall33 reports
• CADD 21-7336-24

  Set, administration, intravascular
  1 recall30 reports
• CADD 21-7339-24

  Set, administration, intravascular
  1 recall25 reports
• CADD 21-7364-24

  Set, administration, intravascular
  73 reports
• CADD 21-7323-24

  Set, administration, intravascular
  1 recall21 reports
• CADD 21-7022-24

  Set, administration, intravascular
  67 reports
• CADD 21-7094-24

  Set, administration, intravascular
  60 reports
• CADD 21-7036-01

  Set, administration, intravascular
  57 reports
• CADD 21-7395-24

  Set, administration, intravascular
  1 recall5 reports
• CADD 21-7390-24

  Set, administration, intravascular
  1 recall4 reports
• CADD 21-2120-0105-231

  Pump, infusion
  1 recall4 reports
• CADD 2110

  ACCESSORIES, PUMP, INFUSION
  1 recall2 reports
• CADD 21-2111-0402-249

  Pump, infusion, pca
  1 recall0 reports
• CADD 21-2112-0402-249

  Set, administration, intravascular
  1 recall0 reports
• CADD 21-7345-24

  Set, administration, intravascular
  49 reports
• CADD 21-7046-24

  Set, administration, intravascular
  45 reports
• CADD 21-0270-25

  Pump, infusion
  40 reports
• CADD 21-7357-24

  Set, administration, intravascular
  37 reports
• CADD 21-6500-13

  Pump, infusion
  36 reports
• CADD 21-2131-25

  Neuraxial Administration Set - Intrathecal delivery
  33 reports
• CADD 21-7059-24

  Set, administration, intravascular
  28 reports
• CADD 21-7450-24

  Pump, infusion
  28 reports
• CADD 21-7386-24

  Set, administration, intravascular
  28 reports
• CADD 21-7115-24

  Set, administration, intravascular
  27 reports
• CADD 21-7081-24

  Set, administration, intravascular
  21 reports
• CADD 21-2131-01

  Set, administration, intravascular
  21 reports
• CADD 21-7044-24

  Set, administration, intravascular
  18 reports
• CADD 21-2160-51

  Pump, infusion, pca
  16 reports
• CADD 21-7061-24

  Set, administration, intravascular
  14 reports
• CADD 21-7034-24

  Set, administration, intravascular
  13 reports
• CADD 21-7355-24

  Set, administration, intravascular
  13 reports
• CADD 21-7105-24

  Set, administration, intravascular
  12 reports
• CADD 21-7375-24

  Set, administration, intravascular
  11 reports
• CADD 21-7024-24

  Set, administration, intravascular
  9 reports
• CADD 21-7040-24

  Set, administration, intravascular
  9 reports
• CADD 21-7091-24

  Set, administration, intravascular
  9 reports
• CADD 21-7108-24

  Set, administration, intravascular
  8 reports
• CADD 21-7109-24

  Set, administration, intravascular
  8 reports

Recent CADD adverse event reports

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

• MalfunctionSep 30, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954003 ↗
• MalfunctionSep 30, 2026Failure to Sense

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953791 ↗
• MalfunctionSep 30, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953123 ↗
• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952833 ↗
• MalfunctionSep 30, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951657 ↗
• MalfunctionSep 30, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951303 ↗
• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950884 ↗
• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950452 ↗
• MalfunctionSep 30, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950029 ↗
• MalfunctionSep 30, 2026Pumping Problem

  It was reported that, upon inspection of the returned CADD-Solis Pump, a Cassette Not Attached error was confirmed through functional testing. In addition, a defective downstream occlusion (DSO) sensor was identified during the evaluation. There was no patient involvement associated with this event, and no patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949309 ↗
• MalfunctionSep 30, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949045 ↗
• MalfunctionSep 30, 2026Pumping Problem

  It was found during the investigation of a returned pump that the customer-reported issue involving a "Cassette Not Properly Attached" alarm was confirmed through investigation testing. This alarm condition is associated with a high-priority alarm and could potentially interrupt therapy if it occurs during patient use. There was no patient involvement or harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949019 ↗
• MalfunctionSep 30, 2026Pumping Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949001 ↗
• MalfunctionSep 30, 2026Device Sensing Problem

  It was reported that during testing the CADD-Solis pump had a defective cassette sensor. There was no patient involvement associated with this event, and no patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947741 ↗
• MalfunctionSep 30, 2026Crack

  It was reported that the pump did not maintain the correct date and time. The issue was identified during testing. During inspection of the returned CADD-Solis pump, a cracked downstream occlusion (DSO) seal was observed. There was no patient involvement associated with this event, and no patient harm was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947545 ↗

Other Icu Medical, Inc. products

• Medfusion16 models · 13,114 reports · 5 recalls
• Bivona469 models · 2,811 reports · 29 recalls
• Level 152 models · 3,733 reports · 1 recall
• Portex409 models · 3,479 reports · 5 recalls
• Cleo6 models · 2,782 reports
• Pneupac23 models · 1,972 reports
• Medex98 models · 774 reports · 23 recalls
• Plum26 models · 1,358 reports · 6 recalls