CADD 21-2111-0401-51Recalls & reported problems

Summary

The FDA's MAUDE database contains 461 adverse event reports that list this exact device (DI 15019517099690), received between Jan 24, 2019 and Sep 30, 2026 — classified as 461 malfunctions.

The most frequently reported specific device problem is “Failure to Infuse” (85 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-1668-2025 · Root cause: Labeling design · Recall details · FDA record ↗

2. 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 · 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-1667-2025 · 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 461 reports, 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 50949045 ↗
• MalfunctionSep 29, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939185 ↗
• MalfunctionSep 28, 2026Defective Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924842 ↗
• MalfunctionSep 24, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889775 ↗
• MalfunctionSep 24, 2026Wireless Communication Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889557 ↗
• MalfunctionSep 24, 2026Failure to Sense

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888940 ↗
• MalfunctionSep 24, 2026Device Sensing Problem

  The device was returned for evaluation following a report of a downstream occlusion sensor malfunction. The results of the investigation confirmed that the DSO sensor was defective. There was no patient involvement or patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50887515 ↗
• MalfunctionSep 23, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876436 ↗
• MalfunctionSep 23, 2026Failure to Sense

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873840 ↗
• MalfunctionSep 22, 2026Failure to Sense

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859094 ↗
• MalfunctionSep 22, 2026Pumping Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858549 ↗
• MalfunctionSep 21, 2026Pumping Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845833 ↗
• MalfunctionSep 18, 2026Failure to Recalibrate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50826947 ↗
• MalfunctionSep 18, 2026Failure to Infuse

  It was reported that the device had alarmed with error code 42224, a high-priority alarm which if recur during use can interrupt therapy. This event resolved with tech support. There was no reported patient involvement and harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50817672 ↗
• MalfunctionSep 17, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809159 ↗
• MalfunctionSep 17, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808635 ↗
• MalfunctionSep 4, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50621045 ↗
• MalfunctionSep 3, 2026Failure to Infuse

  It was reported that the device generated an "Air in Line" alarm during normal clinical use. This alarm condition is associated with a high-priority alarm and could potentially interrupt therapy if it occurs during patient use. Patient involvement is unknown; however, no patient harm or adverse event was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50594286 ↗
• MalfunctionSep 3, 2026Insufficient Flow or Under Infusion

  It was reported that the pump did not deliver adequate pain relief to the patient overnight and was reportedly under-infusing. This resulted in a delay in therapy. There was no patient harm or adverse event reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50589229 ↗
• MalfunctionSep 2, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50567123 ↗
• MalfunctionSep 1, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50550409 ↗
• MalfunctionAug 31, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50527518 ↗
• MalfunctionAug 31, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50526721 ↗
• MalfunctionAug 31, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50526518 ↗
• MalfunctionAug 24, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50418521 ↗

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-1681-2025 · Apr 10, 2025 · Open, Classified
  CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW,
• 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)