CADD 21-2160-51Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10610586031212), received between Jan 8, 2020 and Nov 24, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (5 reports).

7 other recalls cover devices cleared under the same FDA submission (K072144); 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE PUMP RETURNED FROM CLINICAL USE AND CONNECTED TO AC CABLE TO CHARGE. PUMP SWITCHED ON, ON-SCREEN ALARM ¿BATTERY DEPLETED PUMP WILL NOT RUN¿ BATTERY INDICATOR AT 0 PERCENT. BATTERY REMOVED FROM PUMP AND INSERTED INTO THREE DIFFERENT PROVEN FUNCTIONING DEVICES, SAME ALARM ON EACH OCCASION. ON INSPECTION BATTERY INDICATOR WAS ILLUMINATING GREEN. BATTERY PACK INSERTED INTO FOUR DIFFERENT FUNCTIONING PUMPS, ALL FAILED WITH ¿BATTERY DEPLETED PUMP WILL NOT RUN¿ BATTERY INDICATOR AT 0 PERCENT. EVENT OCCURRED AT HOSPITAL DURING PRE-TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23636428 ↗
• MalfunctionJun 3, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE PUMP DISPLAYED ¿BATTERY DEPLETED. PUMP WILL NOT RUN¿ ALERT AND THE ALARM WAS SOUNDING. UNABLE TO PROCEED WITH PUMP SET UP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137284 ↗
• MalfunctionMar 14, 2025Crack; Crack

  IT WAS REPORTED THAT THE RECHARGEABLE BATTERY PACK HOUSING IS CRACKED OR DAMAGED. THE RESULTS OF THE INVESTIGATION FOUND THAT THE BATTERIES LOOKED TO BE IN POOR CONDITION WITH VISIBLE CRACKS SEEN ON SOME OF THE BATTERIES IN THE PICTURES. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21610032 ↗
• MalfunctionDec 22, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERIES WERE UNDER LOW TENSION AND NO LONGER CHARGING. PER REPORTER WHEN THE PUMP WAS CONNECTED AND STARTED TO THE PATIENT FOR CHEMOTHERAPY TREATMENT AT THE HOSPITAL, IT CAUSED THE DEVICE TO EXHIBIT LOW BATTERY ALARM. ADDITIONALLY, THE BATTERY HAD RECENTLY BEEN RECHARGED BEFORE USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18388662 ↗
• MalfunctionDec 22, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERIES WERE UNDER LOW TENSION AND NO LONGER CHARGING. PER REPORTER WHEN THE PUMP WAS CONNECTED AND STARTED TO THE PATIENT FOR CHEMOTHERAPY TREATMENT AT THE HOSPITAL, IT CAUSED THE DEVICE TO EXHIBIT LOW BATTERY ALARM. ADDITIONALLY, THE BATTERY HAD RECENTLY BEEN RECHARGED BEFORE USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383132 ↗
• MalfunctionAug 31, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY DOES NOT CHARGE FULLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15329168 ↗
• MalfunctionOct 27, 2020Complete Loss of Power; Complete Loss of Power

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL BATTERY PACK WAS IMPLICATED IN A PUMP ALARMING AND POWERING DOWN FOR NO REASON. THE PUMPS ARE BEING USED FOR A PEDIATRIC CLINICAL TRIAL. THERE WERE NO ADVERSE EVENTS REPORTED.

  Patient problems: No Information

  MAUDE report 10740102 ↗
• MalfunctionOct 26, 2020Complete Loss of Power; Complete Loss of Power

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL BATTERY PACK IS IMPLICATED IN AN ISSUE WHERE THE PUMP ALARMED AND THEN POWERED DOWN FOR NO REASON. THE PUMP WAS BEING USED FOR A PEDIATRIC CLINICAL TRIAL. THERE WERE NO REPORTED ADVERSE EVENTS.

  Patient problems: No Information

  MAUDE report 10734974 ↗
• MalfunctionJul 15, 2020Failure to Charge; Pumping Stopped; Failure to Charge; Pumping Stopped

  INFORMATION RECEIVED THAT A SMITHS MEDICAL CADD SOLIS BATTERY PACK MAY HAVE CAUSED THE PUMP TO ALARM LOW BATTERY EVEN THOUGH IT WAS PLUGGED. THE REPORTER ALSO STATED THAT THE BATTERY WOULD NOT CHARGE UP. THERE WERE NO CLINICAL CONSEQUENCE DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10279534 ↗
• MalfunctionJul 10, 2020Failure to Charge; Pumping Stopped; Failure to Charge; Pumping Stopped

  INFORMATION RECEIVED THAT A SMITHS MEDICAL CADD SOLIS BATTERY PACK MAY HAVE CAUSED THE PUMP TO ALARM LOW BATTERY EVEN THOUGH IT WAS PLUGGED. THE REPORTER ALSO STATED THAT THE BATTERY WOULD NOT CHARGE UP. THERE WERE NO CLINICAL CONSEQUENCE DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10257970 ↗
• MalfunctionApr 14, 2020Battery Problem; Battery Problem

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL RECHARGEABLE BATTERY PACK WOULD NOT GET FULLY CHARGED; IT ONLY ACCEPTED 75%. THE ISSUE OCCURRED DURING A PROCEDURE AND THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9960088 ↗
• MalfunctionApr 14, 2020Battery Problem; Battery Problem

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL RECHARGEABLE BATTERY PACK WOULD NOT GET FULLY CHARGED; IT ONLY ACCEPTED 75%. THE ISSUE OCCURRED DURING A PROCEDURE AND THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9960085 ↗
• MalfunctionJan 8, 2020Charging Problem; Charging Problem

  INFORMATION RECEIVED A SMITHS MEDICAL CADD ASSESSORIES BATTERY WILL ONLY CHARGE AND ACCEPT 75%. THIS IS CORRECTION AS THIS IS CHANGED TO NON REPORTABLE AS IT IS A BATTERY ACCESSORY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9566611 ↗
• MalfunctionJan 8, 2020Charging Problem; Charging Problem

  REPORT FILED REPORTABLE AS THIS A CADD ACCESSORY AND BATTERY LITHIUM NOT CHARGING 75% IS NOT REPORTABLE . CORRECTION BEING SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9565750 ↗
• MalfunctionJan 8, 2020Charging Problem; Charging Problem

  CORRECTION BEING MADE ON MDR FILE. SUMMARY IN H 10.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9565742 ↗
• MalfunctionJan 8, 2020Charging Problem; Charging Problem

  CORRECTION BEING MADE ON MDR FILE. SUMMARY IN H 10.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9565735 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072144. 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-2419-2024 · Feb 27, 2024 · Open, Classified
  CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximi
• Z-1813-2015 · May 26, 2015 · Terminated
  CADD- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospita
• Z-0166-2015 · Sep 29, 2014 · Terminated
  CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication Safety Software- Administrator allows use of a
• Z-0004-2012 · May 10, 2011 · Terminated
  Smiths Medical, CADD-Solis ambulatory infusion pumps, Models 2100, REF 21-2101-0200-51 and 2110, REF 21-2111-0100-51, Rx Only. Indicated for intravenous, intra-arterial, subcuta
• Z-1033-2011 · Jan 13, 2011 · Terminated
  Smiths Medical, CADD-Solis Ambulatory Infusion Pump, Model Number: 2100 and 2110, Reorder Number 21-2101-00, 21-2101-0100-50, 21-2101-0100-51, 21-2101-0200-02, 21-2101-0200-03, 21-
• Z-1082-2010 · Jan 27, 2010 · Terminated
  Electri-Cord AC Power Cords, IEC 60320 Coupler, Product Reorder Number 21-2145-01 only for use with Smiths Medical CADD-Solis ambulatory infusion pumps, Model 2100. These cords we