CADD 2120 (REF 21-2120-0104-231)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517126617), received between Mar 17, 2021 and Apr 21, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).

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

3 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

   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 · FDA record ↗

2. 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 ↗

3. Apr 10, 2025Open, 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 · FDA record ↗

4. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2021Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED INDICATING THAT WHILE IN USE, A SMITHS MEDICAL CADD SOLIS VIP PUMP WAS NOT INFUSING MEDICATION (CHEMO). IT WAS ALSO REPORTED THAT THE USER WAS INSTRUCTED TO DO SEVERAL THINGS, BUT THE ISSUE COULD NOT BE RESOLVED. SUBSEQUENTLY, USER ARRIVED AT THE CLINIC WITH THE PUMP. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11700595 ↗
• MalfunctionMar 17, 2021Insufficient Flow or Under Infusion; Therapeutic or Diagnostic Output Failure

  PATIENT CAME INTO THE CANCER CENTER FOR DISCONNECTION OF D2 EPOCH (CHEMO REGIMEN) AND RECONNECTION WITH D3 EPOCH VIA CADD PUMP. WHEN PATIENT ARRIVED THEY REPORTED THAT DURING THE NIGHT THEY DISCOVERED THE CADD PUMP WAS NOT INFUSING THE CHEMO. THEY CALLED THE 800 NUMBER ON THE PUMP AND THE CENTER'S ON CALL/SICK AFTER HOURS LINE. THEY WERE INSTRUCTED TO DO SEVERAL THINGS BUT COULD NOT GET THE PUMP RUNNING. THEY WERE INSTRUCTED TO COME TO THE CLINIC IN THE MORNING. WHEN THEY ARRIVED THE PUMP WAS ON, BLINKING GREEN BUT THE BAG APPEARED FULL. THE COUNTER ON THE PUMP SHOWED 500CC TO BE INFUSED (THE WIFE REPORTS THAT SHE CLEARED THE VOLUME INFUSED WHILE TRYING TO GET IT RUNNING AGAIN PER THE SUPPORT STAFF).

  Patient problems: Insufficient Information

  MAUDE report 11504693 ↗

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-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