CADD 21-2131-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 15019517173864), received between Jun 28, 2022 and Jul 25, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (14 reports).

6 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. 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2025Failure to Infuse; Wireless Communication Problem; Failure to Infuse

  IT WAS REPORTED THAT THE DEVICE HAD EXPERIENCED AN INTERMITTENT WIRELESS MODULE CONNECTIVITY ALARM, WHICH WAS AN OUT-OF-BOX FAILURE DURING ITS IMPLEMENTATION AT THE CUSTOMER'S LOCATION. THE EVENT OCCURRED DURING BENCH TEST AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22611624 ↗
• MalfunctionApr 3, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THERE WAS INTERMITTENT CONNECTIVITY WITH THE PUMP DEVICE WHEN IT WAS ATTACHED TO THE AC ADAPTER AND CHARGING. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21767324 ↗
• MalfunctionMar 4, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE CUSTOMER WAS HAVING AN ISSUE WITH THE WIRELESS MODULE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21516049 ↗
• MalfunctionFeb 13, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT SOME MODULES FAILED TO RECONNECT WHEN POWERED UP FOR GO-LIVE, THEY PRODUCE ¿POOR CONNECTION TO MODULE¿ RED-SCREEN ERRORS OR PUMPS BOOT UP AND SHOW NO CHARGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381232 ↗
• MalfunctionDec 23, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE WIRELESS MODULE HAS AN ISSUE. THE CUSTOMER SWITCHED TO ANOTHER MODULE AND FOUND THAT THE WIRELESS CONNECTION DROPS. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21001511 ↗
• MalfunctionDec 12, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT DURING THE INSTALLATION, WHEN THE PUMP AND WIRELESS MODULE WERE PAIRED TOGETHER, IT KEPT HAVING INTERMITTENT CONNECTION TO MODULE ERROR. THE PRODUCT FAULT OCCURRED DURING PRE-TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20920337 ↗
• MalfunctionDec 12, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT UPON IMPLEMENTATION, THE PUMP HAD AN OUT OF BOX FAILURE WITH WIRELESS INTERMITTENT CONNECTION WITH PUMP. THE EVENT OCCURRED DURING IMPLEMENTATION OF PUMP AT FACILITY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20920025 ↗
• MalfunctionDec 10, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE DEVICE ALARMS FOR INTERMITTENT CONNECTION BETWEEN MODULE AND PUMP, THIS WAS AN OUT OF BOX FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20895355 ↗
• MalfunctionDec 5, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED, THAT THE COMMUNICATION MODULE WAS EXPERIENCING INTERMITTENT MODULE CONNECTIVITY ALARM. THE EVENT OCCURRED, UPON OPENING AT THE HOSPITAL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20858964 ↗
• MalfunctionDec 4, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED, THAT UPON IMPLEMENTATION, THE PUMP HAD AN OUT OF BOX FAILURE. WITH WIRELESS INTERMITTENT CONNECTION WITH PUMP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20849909 ↗
• MalfunctionNov 27, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE CADD SOLIS COMMUNICATION MODULE GIVES INTERMITTENT ERROR. THE PRODUCT FAULT OCCURRED IMMEDIATELY ON USE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800380 ↗
• MalfunctionOct 28, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE DEVICE HAD ¿WIRELESS MODULE INTERMITTENT CONNECTION WHEN POLE CLAMP CAPTURE BRACKET IS ATTACHED.¿ PER REPORTER, THE DEVICE OPERATED UNTIL BRACKET WAS ATTACHED. THE ISSUE WAS NOT RESOLVED, AND THE STEPS TAKEN TO RESOLVE THE ISSUE WAS TO REMOVED AND REINSTALLED POLE CLAMP CAPTURE BRACKET. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20547042 ↗
• MalfunctionOct 11, 2024Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT THE WIRELESS COMMUNICATION MODULE HAD A DAMAGED ANTENNA COVER ASSEMBLY SCREWS AND CANNOT BE DISASSEMBLED TO CONNECT THE BATTERY. THE EVENT TOOK PLACE IN THE HOSPITAL. IT WAS AN OUT OF BOX FAILURE. THERE WAS NO PATIENT INVOLVEMENT. EVALUATION OF THE DEVICE IDENTIFIED THE MODULE WAS OPERATING AS INTENDED WHEN TESTED ON A KNOWN GOOD OPERATING SOLIS PCEA PUMP BUT, WHEN ATTACHED TO NEWLY BUILT PUMPS, IT RETURNED THE SAME FAILURE. THE PUMP WOULD INTERMITTENTLY FAIL TO DETECT THE WIRELESS COMMUNICATION MODULE BATTERY DURING THE POWER-UP PROCESS RESULTING IN WIRELESS MODULE INTERMITTENT CONNECTION WITH THE PUMP MESSAGE WHEN POWERING-UP WITH THE AC POWER CORD PLUGGED IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20433558 ↗
• MalfunctionOct 10, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE DEVICE ALARMED FOR AN INTERMITTENT WIRELESS MODULE CONNECTION ERROR WHEN CONNECTED TO AC POWER. THE PRODUCT FAULT OCCURRED UPON OPENING. IT WAS AN OUT OF BOX FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20423413 ↗
• MalfunctionOct 2, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT DEVICE/MODULE WAS EXPERIENCING INTERMITTENT MODULE CONNECTIVITY ALARM. CUSTOMER REQUESTED A REPLACEMENT. THE EVENT OCCURRED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20356217 ↗
• MalfunctionSep 17, 2024Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE DEVICE ALARM STATES UNUSABLE BATTERY, PUMP WOULD NOT RUN. PER REPORTER, THE ISSUE OCCURRED PRIOR TO INFUSION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20240224 ↗
• MalfunctionJul 23, 2024Computer Software Problem; Loose or Intermittent Connection; Telemetry Discrepancy; Computer Software Problem; Loose or Intermittent Connection; Telemetry Discrepancy

  IT WAS REPORTED THAT THE DEVICE HAD AN OUT-OF-BOX FAILURE, WITH THE ALARMS FOR THE WIRELESS MODULE HAVING AN INTERMITTENT CONNECTION. THE DEVICE FAULT OCCURRED UPON OPENING AT THE HOSPITAL. THE OPERATOR OF THE DEVICE WAS AN ICUMED FSE. THIS WAS NOT REPORTED TO FDA. THE ISSUE WAS NOT RESOLVED. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19807783 ↗
• MalfunctionJul 19, 2022Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT AN ERROR CODE/DEPLETED BATTERY KEEPS OCCURRING, BUT THE BATTERY IS FULLY CHARGED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15056473 ↗
• MalfunctionJul 7, 2022Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING TESTING A POLE CLAMP BRACKET CAUSED INTERMITTENT CONNECTION TO MODULE. THERE WAS NO PATIENT INVOLVEMENT OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14946152 ↗
• MalfunctionJun 28, 2022Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT INTERMITTENT COMMUNICATION ERRORS OCCURRED WITH THE PUMP. THE PROBLEM FOLLOWS THE MODULE AND NOT THE PUMP ITSELF. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14848850 ↗
• MalfunctionJun 28, 2022Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT INTERMITTENT COMMUNICATION ERRORS OCCURRED WITH PUMP. THE PROBLEM FOLLOWS THE MODULE AND NOT THE PUMP ITSELF. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14848834 ↗

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-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-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-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-2420-2024 · Feb 27, 2024 · Open, Classified
  CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraop
• 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)