CADD 2120 (REF 21-2120-0103-78)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019517096392), received between Dec 14, 2023 and Jun 23, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

4 other recalls cover devices cleared under the same FDA submission (K111275); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 10, 2025Open, 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 · FDA record ↗

2. Feb 27, 2024Open, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025Failure to Infuse; Air/Gas in Device; Failure to Infuse; Air/Gas in Device

  IT WAS REPORTED THAT THE PUMP EXHIBITED AN AIR IN LINE ALARM. THE LINE HAD APPEARED EMPTIED; HOWEVER, THE PUMP HAD INDICATED THAT 7.9 ML REMAINED. THERE WAS PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308745 ↗
• MalfunctionJun 7, 2024Device Sensing Problem; Scratched Material; Device Sensing Problem; Scratched Material

  IT WAS REPORTED THAT THERE WAS A CASSETTE NOT ATTACHED ERROR. THE EVENT OCCURRED DURING TESTING. THERE WAS NO PHYSICAL DAMAGE REPORTED. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483644 ↗
• MalfunctionMay 17, 2024Failure to Sense; Connection Problem; Failure to Sense; Connection Problem

  IT WAS STATED THAT THE DEVICE HAD A CASSETTE NOT ATTACHED ERROR. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19340427 ↗
• MalfunctionDec 14, 2023Device Alarm System; Air/Gas in Device; Device Alarm System; Air/Gas in Device

  IT WAS REPORTED THAT THE PUMP EXHIBITED AN AIR IN LINE ALARM. TROUBLESHOOTING WAS PERFORMED AND THE PUMP CONTINUED TO ALARM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18331181 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111275. One submission often covers many models, so check the product and lot details in each record.

• Z-1668-2025 · Apr 10, 2025 · Open, Classified
  CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-2120-0
• Z-0222-2025 · Jul 16, 2024 · Open, Classified
  CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Systems: 21-2101-0100-50, 21-2101-
• 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-0107-2022 · Mar 24, 2020 · Terminated
  CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12