CADD 21-2111-0402-51Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,535 adverse event reports that list this exact device (DI 15019517154290), received between Oct 30, 2020 and Sep 28, 2026 — classified as 1,535 malfunctions.

The most frequently reported specific device problem is “Failure to Infuse” (339 reports).

4 FDA recall records name this device's identifier, 4 still open.

3 other recalls cover devices cleared under the same FDA submission (K170982); they may or may not involve this specific model.

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.

Recalls naming this device

1. 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 · Recall details · FDA record ↗

2. 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 · Recall details · FDA record ↗

3. 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 · Recall details · FDA record ↗

4. 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,535 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Excess Flow or Over-Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50920417 ↗
• MalfunctionSep 28, 2026Excess Flow or Over-Infusion

  It was reported that the device delivered a bolus earlier than programmed. The pump was set to administer a 20 mL bolus of 0.2% ropivacaine approximately 3.5 hours after start, with a continuous rate of 1 mL/hour. The settings were verified by two nurses before initiation. Upon starting, the pump immediately began delivering the bolus, which was stopped by the registered nurse after approximately 2.5 mL had been infused. When restarted, the bolus did not resume and no settings were changed. No patient harm or adverse event was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50915661 ↗
• MalfunctionSep 25, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903468 ↗
• MalfunctionSep 25, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902896 ↗
• MalfunctionSep 25, 2026Failure to Infuse

  It was reported that the pump displayed a "cassette was not attached properly" error. Patient involvement associated with this event is unknown. However, if the issue were to recur during an infusion, the pump may not function as intended and could result in an interruption of therapy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898422 ↗
• MalfunctionSep 25, 2026Crack

  It was reported that the pump required reinstallation of a new protocol each time during preventive maintenance. During investigation of the returned CADD pump, a cracked downstream occlusion (DSO) seal was identified. If this condition were to recur during infusion, it could allow fluid ingress into the pump and potentially result in an interruption of therapy. 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 50897924 ↗
• MalfunctionSep 25, 2026Device Sensing Problem

  It was reported that, during testing, the device alarmed indicating that the cassette was partially unlatched after the cassette had been inserted, the door closed, and the cassette locked. During investigation testing, a defective latch lock sensor was confirmed. There was no patient involvement associated with this event, and no patient harm was reported. However, if this issue were to recur during infusion, the pump may not operate as intended and therapy could be interrupted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897812 ↗
• MalfunctionSep 23, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873080 ↗
• MalfunctionSep 22, 2026Pumping Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860506 ↗
• MalfunctionSep 22, 2026High Test Results

  It was found during the investigation of a returned pump that an "Air detector too high" was identified in the Air Detector Height-test. This failure condition could potentially interrupt therapy and may stop the pump if it occurs during patient use. There was no patient involvement or harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50855041 ↗
• MalfunctionSep 22, 2026Pumping Problem

  It was reported that the CADD Solis pump had displayed error code (b)(6) (ERROR_MOTOR_TIMEOUT). There were no patient involvement and no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853837 ↗
• MalfunctionSep 21, 2026Pumping Problem

  It was reported that during testing pump giving Error 41622 after the first pump sequence. The event occurred during testing. During the investigation, it was confirmed that the high-priority error 41622 "ERROR_MOTOR_TIMEOUT" was displayed and recorded in the event log of the returned pump. This failure occurred during testing; however, if it were to recur during infusion, it could result in an interruption of therapy. There are no patient involvement and adverse event reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50844128 ↗
• MalfunctionSep 18, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829056 ↗
• MalfunctionSep 18, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50826790 ↗
• MalfunctionSep 18, 2026Insufficient Flow or Under Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50824127 ↗
• MalfunctionSep 17, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50810727 ↗
• MalfunctionSep 17, 2026Degraded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809269 ↗
• MalfunctionSep 16, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794819 ↗
• MalfunctionSep 16, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794052 ↗
• MalfunctionSep 16, 2026Failure to Infuse

  It was reported that the pump experienced error code 41100. Error code 41100 is associated with an ADC safety signal issue. This error condition is associated with a high-priority alarm and could potentially interrupt therapy if it occurs during patient use. The pump was connected to a wireless communication module at the time of the fault. The event occurred during setup, and the pump was not in use when the error was generated. There was no patient involvement or harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792828 ↗
• MalfunctionSep 16, 2026Device Alarm System

  It was reported that during power up the pump experienced error code 41100 is associated with an ADC safety signal issue. The pump was connected to a wireless communication module at the time of the fault. The errors only occurred after the communication modules were attached and power was then supplied via the AC adapter before being turned on. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792203 ↗
• MalfunctionSep 16, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791547 ↗
• MalfunctionSep 16, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50789685 ↗
• MalfunctionSep 15, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779716 ↗
• MalfunctionSep 15, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779306 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170982. One submission often covers many models, so check the product and lot details in each record.

• Z-1662-2025 · Apr 10, 2025 · Open, Classified
  CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope: PUM
• Z-0466-2025 · Jun 26, 2024 · Open, Classified
  smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis infusion pumps
• Z-0963-2023 · Dec 9, 2022 · Open, Classified
  CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7323-24, 7) REF 21-7324-24, 8)