CADD 21-0270-25Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of CADD (123)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This ICU Medical CADD infusion pump has 40 reports, including one injury and no deaths. Most describe charging adapter problems—failing to charge, melting or arcing contacts, and complete loss of power. One injury report mentions a nurse shocked while plugging in an adapter. No recalls name this device. Reports dropped to zero in the last 12 months from 17.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 40
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 15019517126884), received between Oct 26, 2020 and Sep 4, 2025 — classified as 1 injury, 39 malfunctions.
The most frequently reported specific device problem is “Break” (12 reports).
6 other recalls cover devices cleared under the same FDA submission (K111275); 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.
Reports received per month
Most reported problems
Device problems
- Break12
- Unexpected Shutdown9
- Complete Loss of Power4
- Melted3
- Connection Problem2
- Material Deformation2
- Product Quality Problem2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions36
- No Information2
- Erythema1
- Full thickness (Third Degree) Burn1
- Insufficient Information1
- Partial thickness (Second Degree) Burn1
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE AC ADAPTOR WAS NOT CHARGING THE DEVICE, AND THAT THERE APPEARED TO HAVE BEEN SOME ARCING OR BURNING OCCURRING AND MELTING OF CONTACTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22962801 ↗MalfunctionAug 13, 2025Improper Flow or Infusion; Complete Loss of Power; Improper Flow or Infusion; Complete Loss of Power
IT WAS REPORTED THAT THE CADD PUMP LOST POWER DURING PATIENT-CONTROLLED ANALGESIA ADMINISTRATION. PER REPORTER, THE LOSS OF POWER WAS THE RESULT OF BATTERY DEPLETION, AS THE PUMP WAS PLUGGED IN TO CHARGE, BUT THE POWER ADAPTER WAS DEFECTIVE AND WAS NOT CHARGING THE DEVICE. THE REPORTER DID NOT INDICATE ANY ALARM EMITTED FROM THE PUMP TO INDICATE THE USER OF THE BATTERY DEPLETION. THE PUMP WAS REPLACED TO RESUME INFUSION AND THE ISSUE WAS RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22795092 ↗MalfunctionJun 23, 2025Device Emits Odor; Device Emits Odor
IT WAS REPORTED THAT THERE WAS A STRONG BURN SMELL WAS COMING FROM DEVICE. THE FAULTY POWER SUPPLY WAS REMOVED FROM SERVICE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22311674 ↗MalfunctionJun 18, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
THE CUSTOMER RETURNED THE PRODUCT FOR A DEFECTIVE ALTERNATING CURRENT (AC) ADAPTER, AND DURING INSPECTION IT WAS FOUND THAT THE AC ADAPTER COVER ON THE BODY CONNECTION SIDE OF THE PLUG HAD COME OFF AND WAS DAMAGED. AFTER INVESTIGATION THE RESULTS INDICATED A REPORTABLE MALFUNCTION DUE TO THE DAMAGE ON THE AC ADAPTER. THE EVENT OCCURRED DURING UNPACKING AT FACILITY, AND THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22284391 ↗MalfunctionJun 3, 2025Melted; Melted
IT WAS REPORTED THAT UPON REVIEWING NO CHARGE WITH AC ADAPTOR. CUSTOMER JUST WANTED TO BRING TO ICU MEDICAL¿S ATTENTION AN ISSUE THAT THEY ARE STARTING TO SEE WITH THE CADD SOLIS PLUG PACKS AND NOTICED A FEW INSTANCES RECENTLY OF CONTACT ISSUE WITH THE PLUG ADAPTER ON THE POWER PACK. THERE SEEMS TO HAVE BEEN SOME ARCING OR, BURNING OCCURRING AND MELTING OF CONTACTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22137308 ↗MalfunctionJun 3, 2025Melted; Melted
IT WAS REPORTED THAT UPON REVIEWING NO CHARGE WITH AC ADAPTOR. CUSTOMER JUST WANTED TO BRING TO ICU MEDICAL¿S ATTENTION AN ISSUE THAT THEY ARE STARTING TO SEE WITH THE CADD SOLIS PLUG PACKS AND NOTICED A FEW INSTANCES RECENTLY OF CONTACT ISSUE WITH THE PLUG ADAPTER ON THE POWER PACK. THERE SEEMS TO HAVE BEEN SOME ARCING OR, BURNING OCCURRING AND MELTING OF CONTACTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22137254 ↗InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A NURSE RECEIVED AN ELECTRIC SHOCK WHEN THEY WENT TO PLUG AN ALTERNATING CURRENT (AC) ADAPTER INTO THE SOCKET FOR CHARGING AN INFUSION PUMP. THEIR FINGER GOT BLACK, AND THE SKIN ON THEIR ARM WAS RED. IT WAS REPORTED THAT THE FACILITY SUBSEQUENTLY CHECKED THE SOCKET AND NOTHING IS WRONG. ADDITIONALLY, THERE WAS NO VISIBLE DAMAGE TO THE AC ADAPTER.
Patient problems: Erythema; Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn
MAUDE report 21767794 ↗MalfunctionFeb 5, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT "AC PLUG DEFORMATION (BENDING)." IT WAS UNKNOWN WHETHER THE INCIDENT OCCURRED DURING PATIENT USE, BUT NO PATIENT HARM OR ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21312976 ↗MalfunctionNov 26, 2024Break; Break
IT WAS REPORTED THAT THERE WERE 9 BROKEN PLUGS THAT HAD DAMAGED ENDS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20782530 ↗MalfunctionNov 26, 2024Break; Break
IT WAS REPORTED THAT THERE WERE 9 BROKEN PLUGS THAT HAD DAMAGED ENDS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20782258 ↗MalfunctionNov 26, 2024Break; Break
IT WAS REPORTED THAT THERE WERE 9 BROKEN PLUGS THAT HAD DAMAGED ENDS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20782023 ↗MalfunctionNov 26, 2024Break; Break
IT WAS REPORTED THAT THERE WERE 9 BROKEN PLUGS THAT HAD DAMAGED ENDS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20781928 ↗MalfunctionNov 26, 2024Break; Break
IT WAS REPORTED THAT THERE WERE 9 BROKEN PLUGS THAT HAD DAMAGED ENDS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20780876 ↗MalfunctionNov 26, 2024Break; Break
IT WAS REPORTED THAT THERE WERE 9 BROKEN PLUGS THAT HAD DAMAGED ENDS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20780304 ↗MalfunctionNov 26, 2024Break; Break
IT WAS REPORTED THAT THERE WERE 9 BROKEN PLUGS THAT HAD DAMAGED ENDS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20779356 ↗MalfunctionNov 26, 2024Break; Break
IT WAS REPORTED THAT THERE WERE 9 BROKEN PLUGS THAT HAD DAMAGED ENDS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20776927 ↗MalfunctionNov 25, 2024Break; Break
IT WAS REPORTED, THAT THERE WERE 9 BROKEN PLUGS. THAT HAD DAMAGED ENDS. THERE WAS UNKNOWN, PATIENT INVOLVEMENT. AND UNKNOWN, PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20774613 ↗MalfunctionOct 25, 2024Break; Break
IT WAS REPORTED THAT THE AFFECTED AC ADAPTOR DID NOT CHARGE WITH THE CADD SOLIS PUMP. THE AC ADAPTOR WAS BROKEN. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. EVENT OCCURRED AT THE HOSPITAL. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20538628 ↗MalfunctionOct 22, 2024Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT THE POWER SUPPLIERS HAVE VARIOUS PROBLEMS, MAINLY NOT CHARGING DUE TO INTERNAL BREAKS INSIDE LIKELY IN THE CABLE, SOME HAS PROBLEMS CHARGING FOR SHORT TIME THEN SHUTS DOWN. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20510162 ↗MalfunctionOct 22, 2024Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT THE POWER SUPPLIERS HAVE VARIOUS PROBLEMS, MAINLY NOT CHARGING DUE TO INTERNAL BREAKS INSIDE LIKELY IN THE CABLE, SOME HAS PROBLEMS CHARGING FOR SHORT TIME THEN SHUTS DOWN. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20509991 ↗MalfunctionOct 22, 2024Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT THE POWER SUPPLIERS HAVE VARIOUS PROBLEMS, MAINLY NOT CHARGING DUE TO INTERNAL BREAKS INSIDE LIKELY IN THE CABLE, SOME HAS PROBLEMS CHARGING FOR SHORT TIME THEN SHUTS DOWN. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20509519 ↗MalfunctionOct 21, 2024Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT THE POWER SUPPLIERS HAVE VARIOUS PROBLEMS, MAINLY NOT CHARGING DUE TO INTERNAL BREAKS INSIDE LIKELY IN THE CABLE, SOME HAS PROBLEMS CHARGING FOR SHORT TIME THEN SHUTS DOWN. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20493540 ↗MalfunctionOct 18, 2024Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT THE POWER SUPPLIERS HAVE VARIOUS PROBLEMS, MAINLY NOT CHARGING DUE TO INTERNAL BREAKS INSIDE LIKELY IN THE CABLE, SOME HAS PROBLEMS CHARGING FOR SHORT TIME THEN SHUTS DOWN. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20488525 ↗MalfunctionOct 18, 2024Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT THE POWER SUPPLIERS HAVE VARIOUS PROBLEMS, MAINLY NOT CHARGING DUE TO INTERNAL BREAKS INSIDE LIKELY IN THE CABLE, SOME HAS PROBLEMS CHARGING FOR SHORT TIME THEN SHUTS DOWN. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20488509 ↗MalfunctionOct 18, 2024Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT THE POWER SUPPLIERS HAVE VARIOUS PROBLEMS, MAINLY NOT CHARGING DUE TO INTERNAL BREAKS INSIDE LIKELY IN THE CABLE, SOME HAS PROBLEMS CHARGING FOR SHORT TIME THEN SHUTS DOWN. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20488389 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K111275. One submission often covers many models, so check the product and lot details in each record.
- Z-1682-2025 · Apr 10, 2025 · Open, ClassifiedCADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-01; 2) PUMP KIT, CADD-SOLIS VIP
- Z-1668-2025 · Apr 10, 2025 · Open, ClassifiedCADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-2120-0
- Z-0222-2025 · Jul 16, 2024 · Open, ClassifiedCADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Systems: 21-2101-0100-50, 21-2101-
- Z-0466-2025 · Jun 26, 2024 · Open, Classifiedsmiths 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-2421-2024 · Feb 27, 2024 · Open, ClassifiedCADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proxi
- Z-0107-2022 · Mar 24, 2020 · TerminatedCADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 2
Other Pump, infusion devices
- Alaris 8100Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths650,218 reports
- Alaris 8100Carefusion 303, Inc. · Pump, infusion4 recalls78 deaths344,514 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion2 recalls45 deaths148,093 reports
- BD® Alaris™ Pump Module, Model 8100Carefusion 303, Inc. · Pump, infusion5 recalls30 deaths51,256 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls4 deaths21,956 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths15,547 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion3 recalls6 deaths13,022 reports
- CADD 21-6500-51Icu Medical, Inc. · Pump, infusion2 deaths8,231 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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