CADD 2110 (REF 21-2111-0401-249)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517101027), received between Jun 7, 2024 and Jun 14, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

5 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2024Device Alarm System; Defective Device; Device Alarm System; Defective Device

  IT WAS REPORTED THAT THE PUMP FROZE WITH AN ERROR. THE PUMP DISCHARGED SUDDENLY FROM FULL BATTERY AND THE CHARGING SIGNAL CAME BACK AFTERWARDS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ ADVERSE EVENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19539537 ↗
• MalfunctionJun 7, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT A DOWNSTREAM ALARM OCCURRED BETWEEN THE PUMP AND PATIENT. THERE WAS UNKNOWN PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 19483677 ↗

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-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-1681-2025 · Apr 10, 2025 · Open, Classified
  CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW,
• 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-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)