CADD 21-2111-0402-78Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15019517154887), received between Oct 24, 2024 and Dec 16, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (2 reports).

3 FDA recall records name this device's identifier, 3 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

   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 ↗

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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Device Sensing Problem; Device Sensing Problem

  THE CUSTOMER RETURNED THE DEVICE STATING, ¿THERE WAS A CASSETTE SENSOR ERROR¿. DURING DEVICE EVALUATION IT WAS FOUND THE DOWNSTREAM OCCLUSION SEAL WAS DAMAGED. THE EVENT OCCURRED DURING TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816014 ↗
• MalfunctionNov 28, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE DEVICE EXHIBITED A DOWNSTREAM OCCLUSION ALARM. THE PATIENT¿S MOTHER HAD CONTINUED ATTEMPTS TO GET THE PUMP TO RUN AND RESOLVE THE ALARM, BUT THE ALARM PERSISTED. THE REPORTER NOTED THAT ICING AND ELEVATION HAD BEEN APPLIED, REPOSITIONING HAD BEEN DONE, AND TIME HAD BEEN ALLOWED FOR TISSUE REABSORPTION, BUT THE PUMP CONTINUED TO ALARM. NO KINKS WERE PRESENT IN THE TUBING, AND ALL CLAMPS HAD REMAINED OPEN AND SLIDING. THE PUMP WAS RUNNING AT THE TIME OF THE CALL, BUT IT WAS STATED THAT THE ALARM WOULD OCCUR WHEN THE PUMP CYCLED AND WOULD ONLY STOP WHEN A BUTTON WAS PRESSED. THE REPORTER INDICATED THAT THEY HAD BEEN GIVEN A CONTACT NUMBER FOR ANESTHESIA AND PLANNED TO CALL THEM TO REQUEST A DIFFERENT PUMP FOR THEIR SON AND TO INQUIRE IF ANYTHING COULD BE DONE REGARDING CATHETER PLACEMENT, AS THIS MIGHT BE AFFECTING THE PUMP¿S FUNCTION. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23674009 ↗
• MalfunctionJun 24, 2025Failure to Calibrate; Device Sensing Problem; Failure to Calibrate; Device Sensing Problem

  IT WAS REPORTED THAT THE CASSETTE SENSOR ENCOUNTERED AN ERROR DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319945 ↗
• MalfunctionJun 17, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE PUMP HAS A HOLE AND AN UPSTREAM OCCLUSION. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236959 ↗
• MalfunctionOct 24, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE PUMP WAS UNDER INFUSING. OCCURRED DURING TESTING. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523981 ↗

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-1667-2025 · Apr 10, 2025 · Open, Classified
  CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SO
• 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)