CADD 21-2131-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 15019517171969), received between Oct 28, 2020 and Sep 2, 2025 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (20 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE COMMUNICATION MODULE HAD ¿COMMUNICATION MODULE INTERMITTENT CONNECTION" ERROR WITH THE PUMP. THE EVENT OCCURRED AT THE HOSPITAL. SAMPLE PHOTO WAS PROVIDED FOR INVESTIGATION. THERE WAS NO REPORTED PATIENT INVOLVEMENT. ASSOCIATED PUMP COMPLAINT WAS DOCUMENTED ON (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22932109 ↗
• MalfunctionJun 23, 2025Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT THERE WAS COMMUNICATION MODULE INTERMITTENT CONNECTION. PATIENT INVOLVEMENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309786 ↗
• MalfunctionApr 18, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE SCREEN DISPLAYED A RED ERROR MESSAGE 41786 ALONG WITH CONTINUOUS ALARMS. TROUBLE SHOOTING WAS PERFORMED, BUT THE SAME ERROR CODE KEPT APPEARING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21866139 ↗
• MalfunctionApr 18, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE DEVICE SHOWED AN ERROR CODE 41100. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865774 ↗
• MalfunctionMar 27, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PUMP'S COMM-MODULE WAS DEFECTIVE, AND THE WIRELESS MODULE WAS EXPERIENCING AN INTERMITTENT CONNECTION WITH THE PUMP. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21709156 ↗
• MalfunctionMar 27, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PUMP'S COMM-MODULE WAS DEFECTIVE, AND THE WIRELESS MODULE WAS EXPERIENCING AN INTERMITTENT CONNECTION WITH THE PUMP. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21709127 ↗
• MalfunctionMar 27, 2025Failure to Infuse; Wireless Communication Problem; Failure to Infuse; Wireless Communication Problem

  IT WAS REPORTED THAT THE PUMP ONLY POWERED ON WHEN PLUGGED IN AND DISPLAYED THE FOLLOWING ERROR ON THE SCREEN, WIRELESS MODULE INTERMITTENT CONNECTION WITH PUMP. THE COMMUNICATION MODULE AND BATTERY PACK WERE NOT RECOGNIZED BY THE PUMP. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707159 ↗
• MalfunctionMar 27, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PUMP'S COMM-MODULE WAS DEFECTIVE, AND THE WIRELESS MODULE WAS EXPERIENCING AN INTERMITTENT CONNECTION WITH THE PUMP. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707133 ↗
• MalfunctionMar 20, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DEVICE HAS WIRELESS MODULE INTERMITTENT CONNECTION ISSUES. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21657349 ↗
• MalfunctionMar 11, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THERE WAS A PERSISTENT INTERMITTENT WI-FI CONNECTIVITY ERROR DESPITE RE-PUSHING THE SNS FILE. THE PRODUCT FAULT OCCURRED DURING PRE-TEST AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574158 ↗
• MalfunctionMar 11, 2025Intermittent Communication Failure; Intermittent Communication Failure

  IT WAS REPORTED THAT THE DOSE CORD INPUT CONNECTION IS NOT WORKING AND THE COMMUNICATION HAS AN INTERMITTENT SIGNAL. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN HARM/ADVERSE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21573208 ↗
• MalfunctionFeb 20, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE WIRELESS COMMUNICATION MODULE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21422249 ↗
• MalfunctionJan 8, 2025Loose or Intermittent Connection; Wireless Communication Problem; Intermittent Communication Failure; Loose or Intermittent Connection; Wireless Communication Problem; Intermittent Communication Failure

  IT WAS REPORTED THAT THE CADD SOLIS PUMP WITH THE 2131 COMMUNICATION MODULE GAVE AN ERROR FOR "WIRELESS MODULE INTERMITTENT CONNECTION TO PUMP". THE ALARM SEEMED VERY RANDOM BUT ONLY CAME ON WHEN CONNECTED TO AC POWER SUPPLY. THIS MADE SENSE IF THE BATTERY PACK WAS SOMEHOW GETTING DISCONNECTED. WHEN NOT CONNECTED TO AC POWER SUPPLY, THE UNIT SIMPLY SHUT DOWN WITH NO ALARM. ALL CONNECTIONS WERE CLEAN, AND THE PLASTIC CONTACT COVERS WERE REMOVED BETWEEN THE COMMUNICATION AND THE PUMP. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102987 ↗
• MalfunctionJan 8, 2025Power Problem; Wireless Communication Problem; Power Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PUMP RANDOMLY HAD AN ISSUE WITH WIRELESS CONNECTION AND POWER. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102986 ↗
• MalfunctionJan 8, 2025Failure to Infuse; Wireless Communication Problem; Failure to Infuse; Wireless Communication Problem

  IT WAS REPORTED THAT THERE WAS AN INTERMITTENT ISSUE WITH BOTH THE BOLUS CORD AND WIRELESS CONNECTIVITY. PER REPORTER, THE FILE WAS PUSHED TWICE, WI-FI MODULE RESEATED, AND A NEW BOLUS CORD WAS TRIED, BUT THE ISSUE PERSISTED. THERE WAS UNKNOWN PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102839 ↗
• MalfunctionDec 19, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE DEVICE HAD A WIRELESS INTERMITTENT SIGNAL. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20976570 ↗
• MalfunctionNov 27, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE DEVICE SHOWS AN ERROR " WIRELESS MODULE INTERMITTENT CONNECTION WITH PUMP". THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20802339 ↗
• MalfunctionNov 25, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE COMMUNICATION MODULE WAS SHOWING FREQUENT "WIRELESS CONNECTION ERROR." WHEN THE ERROR OCCURRED, IT DID NOT ALLOW THE USER TO PROCEED WITH THE USE OF THE PUMP. THE ONLY WAY TO CLEAR THE ERROR WAS TO PHYSICALLY REMOVE THE TOP HAT AND RE-ATTACH IT. EVEN WHEN THE COMMUNICATION MODULE WAS SWAPPED WITH ANOTHER PUMP, THE ERROR TRAVELLED WITH IT. REPORTER HAS VERIFIED THAT THERE WERE NO INSULATION RUBBER TIPS LEFT ON THE PINS. THE ERROR OCCURRED DURING THE INFUSION, AND NURSE MENTIONED SHE SWAPPED THE PUMP TO CONTINUE PATIENT MEDICATION. THE EVENT OCCURRED IN A CLINICAL SETTING AND WAS NOTED IN DEVICE HISTORY. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20773804 ↗
• MalfunctionNov 11, 2024Failure to Infuse; Wireless Communication Problem; Failure to Infuse; Wireless Communication Problem

  IT WAS REPORTED THAT THE WIRELESS COMMUNICATION MODULE WAS NOT WORKING (OUT OF BOX). THE RESULTS OF THE INVESTIGATION FOUND THAT THERE WAS A DEPLETED BATTERY STATUS. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20659002 ↗
• MalfunctionNov 11, 2024Failure to Infuse; Wireless Communication Problem; Failure to Infuse; Wireless Communication Problem

  IT WAS REPORTED THAT THE WIRELESS COMMUNICATION MODULE WAS NOT WORKING (OUT OF BOX). THE RESULTS OF THE INVESTIGATION FOUND THAT THERE WAS A DEPLETED BATTERY STATUS. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20658571 ↗
• MalfunctionNov 8, 2024Circuit Failure; Wireless Communication Problem; Circuit Failure; Wireless Communication Problem

  IT WAS REPORTED THAT THE MODULE WAS SHOWING FREQUENT "WIRELESS CONNECTION ERROR". WHEN THE ERROR OCCURRED, IT DID NOT ALLOW THE USER TO PROCEED WITH THE USE OF PUMP. THE ONLY WAY TO CLEAR THE ERROR WAS TO PHYSICALLY REMOVE THE TOP HAT AND RE-ATTACH IT. EVEN WHEN THE COMMUNICATION MODULE WAS SWAPPED WITH ANOTHER PUMP, THE ERROR TRAVELLED WITH IT. REPORTER VERIFIED THAT THERE WERE NO INSULATION RUBBER TIPS LEFT ON THE PINS. THE EVENT OCCURRED IN A CLINICAL SETTING AND OCCURRED DURING START UP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20637195 ↗
• MalfunctionOct 28, 2024Failure to Infuse; Wireless Communication Problem; Failure to Infuse; Wireless Communication Problem

  IT WAS REPORTED THAT THE DEVICE HAD AN INTERMITTENT CONNECTIVITY ALARM AND WOULD NOT RUN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20549686 ↗
• MalfunctionOct 28, 2024Failure to Infuse; Wireless Communication Problem; Failure to Infuse; Wireless Communication Problem

  IT WAS REPORTED THAT THE DEVICE HAD WIRELESS MODULE INTERMITTENT CONNECTION ISSUES. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20547395 ↗
• MalfunctionOct 28, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE DEVICE HAD A WIRELESS MODULE INTERMITTENT CONNECTION ISSUE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20544196 ↗
• MalfunctionJul 2, 2024Circuit Failure; Wireless Communication Problem; Circuit Failure; Wireless Communication Problem

  IT WAS REPORTED THAT MODULE WAS SHOWING FREQUENT "WIRELESS CONNECTION ERROR". WHEN THE ERROR OCCURRED, IT DID NOT ALLOW USER TO PROCEED WITH THE USE OF PUMP. THE ONLY WAY TO CLEAR THE ERROR WAS TO PHYSICALLY REMOVE THE TOP HAT AND RE-ATTACH IT. EVEN WHEN THE COMMUNICATION MODULE WAS SWAPPED WITH ANOTHER PUMP, THE ERROR TRAVELLED WITH IT. REPORTER HAS VERIFIED THAT THERE WERE NO INSULATION RUBBER TIPS LEFT ON THE PINS. THE EVENT OCCURRED DURING START UP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660700 ↗

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-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-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-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)