CADD 2110 (REF 21-2112-0401-78)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517101034), received between May 7, 2026 and May 7, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Infuse” (1 report).

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

4 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. 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-1681-2025 · 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-2420-2024 · Root cause: Software Manufacturing/Software Deployment · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Failure to Infuse

  IT WAS FOUND DURING INVESTIGATION THAT THE REPORTED CASSETTE ATTACHMENT ERROR WAS CONFIRMED THROUGH LOGS. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25111752 ↗

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-1662-2025 · Apr 10, 2025 · Open, Classified
  CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected products associated with the change in scope: PUM
• 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)