CADD 2120 (REF 21-2125-0104-01)Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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

   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. 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 ↗

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 ↗

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