CADD 21-2120-0103-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019517084344), received between Sep 13, 2022 and Oct 7, 2024 — classified as 4 malfunctions.

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

6 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

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.

• MalfunctionOct 7, 2024Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE DEVICE WAS ALARMING WITH THE SCREEN MESSAGE, "CASSETTE NOT ATTACHED PROPERLY. REATTACH CASSETTE." THIS EVENT OCCURRED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20385144 ↗
• MalfunctionSep 18, 2024Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THERE WAS CODE 42224.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20252352 ↗
• MalfunctionNov 9, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT A FENTANYL PUMP APPEARED TO CONTINUE TO INFUSE EVEN WHEN AIR IN THE LINE WAS DETECTED. THE ALARM, AIR IN THE LINE, WAS NOTED. BY THE TIME THE FENTANYL BAG WAS CHANGED, THE TUBING WAS FILLED WITH AIR ALMOST ALL THE WAY TO THE HUB CONNECTING IT TO THE PRIMARY INTRAVENOUS TUBING. A FEW MORE MINUTES OF BEING DELAYED WOULD HAVE MEANT THAT THE PATIENT WOULD HAVE RECEIVED AIR VIA THE INTRAVENOUS TUBING VIA A CENTRAL VENOUS CATHETER INTO THE INTERNAL JUGULAR. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759072 ↗
• MalfunctionSep 13, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT A FENTANYL PUMP APPEARED TO CONTINUE TO INFUSE EVEN WHEN AIR IN THE LINE WAS DETECTED. THE ALARM, AIR IN THE LINE, WAS NOTED. BY THE TIME THE FENTANYL BAG WAS CHANGED, THE TUBING WAS FILLED WITH AIR ALMOST ALL THE WAY TO THE HUB CONNECTING IT TO THE PRIMARY INTRAVENOUS TUBING. A FEW MORE MINUTES OF BEING DELAYED WOULD HAVE MEANT THAT THE PATIENT WOULD HAVE RECEIVED AIR VIA THE INTRAVENOUS TUBING VIA A CENTRAL VENOUS CATHETER INTO THE INTERNAL JUGULAR. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15412922 ↗

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-1682-2025 · Apr 10, 2025 · Open, Classified
  CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-01; 2) PUMP KIT, CADD-SOLIS VIP
• 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-2421-2024 · Feb 27, 2024 · Open, Classified
  CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proxi
• 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. 21-2120-0105-12L g. 2