CADD 21-7386-24Recalls & 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 Solus infusion set is a disposable administration set used to deliver IV fluids and drugs. The 28 reports mostly describe leaking tubing near the cassette or pump connection, along with a few cases of the set coming apart or its material degrading. None of the reports describe a death or an injury. There are no recalls naming this device, and reports have slowed from 4 in the earlier 12 months to 2 in the most recent.
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
- 28
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 15019517161977), received between Jan 19, 2021 and Dec 16, 2025 — classified as 28 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (21 reports).
3 other recalls cover devices cleared under the same FDA submission (K031361); 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
- Fluid/Blood Leak21
- Break3
- Peeled/Delaminated2
- Device Alarm System1
- Disconnection1
- Loose or Intermittent Connection1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- Insufficient Information4
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE PATIENT NOTED THAT THE TUBING WAS LEAKING, JUST PAST THE CASSETTE TOWARD THE PATIENT. THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23821010 ↗MalfunctionDec 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE PATIENT NOTED THAT THE TUBING WAS LEAKING, JUST PAST THE CASSETTE TOWARD THE PATIENT. THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23821001 ↗MalfunctionAug 28, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE PATIENT WAS INFUSING IV HYDRATION AND NOTED LEAKING FROM TUBING AT END OF CASSETTE ON WAY TO PATIENT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22916071 ↗MalfunctionAug 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT CADD SOLIS LINES LEAKING WHEN INFUSING. THE PATIENT TRIED A 2ND LINE, SAME LOT # (6093201) AND IT LEAKED AS WELL. PATIENT HAD A DIFFERENT LOT NUMBER LINE AND WAS ABLE TO INFUSE WITHOUT PROBLEMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22775610 ↗MalfunctionAug 11, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT CADD SOLIS LINES LEAKING WHEN INFUSING. THE PATIENT TRIED A 2ND LINE, SAME LOT # (6093201) AND IT LEAKED AS WELL. PATIENT HAD A DIFFERENT LOT NUMBER LINE AND WAS ABLE TO INFUSE WITHOUT PROBLEMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22775607 ↗MalfunctionFeb 20, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE PATIENT HAD AN ISSUE WITH CADD SOLIS VIP TUBING LEAKING AT TUBING INSERTION POINT INTO CASSETTE THAT ATTACHES TO PUMP. THE ISSUE HAPPENED TWO TIMES AND ONE TUBING WAS SAVED. THERE WAS PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21423575 ↗MalfunctionOct 15, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A LEAK IN LINE CLOSE TO WHERE IT CONNECTED TO PUMP WAS DISCOVERED. THIS OCCURRED WHEN PATIENT WAS PRIMING LINE, NOT WHEN ATTACHED TO PATIENT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20458035 ↗MalfunctionJun 9, 2024Disconnection; Disconnection
IT WAS REPORTED A NURSE OBSERVED THE DISPOSABLE SET THAT CAME APART DURING AN INFUSION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19495434 ↗MalfunctionOct 27, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE PATIENT'S MOM CALLED IN WHEN SHE DISCOVERED A LEAK IN THE PATIENTS "TPN TUBING" DURING HER "HEPLOC". THE LEAK WAS SMALL, AND HAD NOT SPILLED BEYOND THE CASSETTE AND PUMP, WHERE IT HAD POOLED A BIT. THERE WAS NO "TPN" SEEPAGE INTO HER BACKPACK. THE LEAK WAS IN THE OVERLAPPING SECTIONS OF THE TUBE AS IT CONNECTS. NO PATIENT INJURY REPORTED. CUSTOMER STATED THAT THEY ARE UNABLE TO PROVIDE PATIENT INFORMATION WITHOUT PATIENT CONSENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18024097 ↗MalfunctionJul 11, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE DEVICE EXHIBITED A LEAKING ISSUE, LEAKING ON THE PATIENT END OF THE TUBING. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17299745 ↗MalfunctionJul 11, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE DEVICE EXHIBITED A LEAKING ISSUE, LEAKING ON THE PATIENT END OF THE TUBING. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17299683 ↗MalfunctionJul 11, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE DEVICE EXHIBITED A LEAKING ISSUE, LEAKING ON THE PATIENT END OF THE TUBING. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17299667 ↗MalfunctionMay 31, 2023Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE DISPOSABLE WAS SEPARATED FROM THE HUB AT THE END. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17031793 ↗MalfunctionMay 31, 2023Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE DISPOSABLE WAS SEPARATED FROM THE HUB AT THE END. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17031478 ↗MalfunctionOct 14, 2022Fluid/Blood Leak; Fluid/Blood Leak
(3/3 REFERENCE (B)(4) FOR RELATED COMPLAINTS) (DOCUMENTING THIRD ADMINISTRATION SET) PER COMPLAINT FORM: LINE WAS LEAKING WHERE THE TUBING INSERTS INTO THE LUER END (THE LUER LOCKS INTO THE PATIENT'S CENTRAL LINE). SECOND UNIT REPORTED SIMILAR PROBLEMS WITH THE SAME LOT NUMBER. REPLACED WITH NEW LOT AND NO REPORTED ISSUES. NUMBER OF UNITS INVOLVED IN COMPLAINT IS UNKNOWN BUT MORE THAN 2. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15611469 ↗MalfunctionOct 14, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE LINE WAS LEAKING WHERE THE TUBING INSERTS INTO THE LUER END. SECOND UNIT REPORTED SIMILAR PROBLEMS WITH THE SAME LOT NUMBER. REPLACED WITH NEW LOT AND NO REPORTED ISSUES. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15610983 ↗MalfunctionOct 14, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE LINE WAS LEAKING WHERE THE TUBING INSERTS INTO THE LUER END. SECOND UNIT REPORTED SIMILAR PROBLEMS WITH THE SAME LOT NUMBER. REPLACED WITH NEW LOT AND NO REPORTED ISSUES. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15610938 ↗MalfunctionJul 27, 2022Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE CONNECTORS ARE SLIPPING OUT AND IT APPEARS VARIOUS PARTS WERE NOT ASSEMBLED TIGHT ENOUGH. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15116983 ↗MalfunctionJan 4, 2022Device Alarm System; Device Alarm System
INFORMATION WAS RECEIVED INDICATING THAT A PUMP USING A CADD ADMINISTRATION SET WAS ALARMING LINE NOT ATTACHED WHEN USING CM7386. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13153063 ↗MalfunctionApr 27, 2021Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED REGARDING A CADD ADMINISTRATION SET. IT WAS REPORTED THAT THE DEVICE LEAKED. THIS OCCURRED DURING INFUSION; EFFECT ON PATIENT IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 11734928 ↗MalfunctionApr 27, 2021Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED REGARDING A CADD ADMINISTRATION SET. IT WAS REPORTED THAT THE DEVICE LEAKED. THIS OCCURRED DURING INFUSION; EFFECT ON PATIENT IS UNKNOWN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11734904 ↗MalfunctionApr 27, 2021Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED REGARDING A CADD ADMINISTRATION SET. IT WAS REPORTED THAT THE DEVICE LEAKED. THIS OCCURRED DURING INFUSION; EFFECT ON PATIENT IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 11734875 ↗MalfunctionApr 27, 2021Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED REGARDING A CADD ADMINISTRATION SET. IT WAS REPORTED THAT THE DEVICE LEAKED. THIS OCCURRED DURING INFUSION; EFFECT ON PATIENT IS UNKNOWN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11733533 ↗MalfunctionMar 22, 2021Break; Material Integrity Problem; Break; Material Integrity Problem
INFORMATION WAS RECEIVED REGARDING A CADD ADMINISTRATION SET. IT WAS REPORTED THAT DEVICE BROKE IN THE MIDDLE OF THE NIGHT DURING INFUSION. THE MEDICATION DID NOT LEAK ON THE PATIENT. THE SAMPLE WAS DISCARDED. THERE WAS NO INJURY NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11548208 ↗MalfunctionFeb 5, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE DEVICE WAS IN USE AND FOUND TO LEAK. NO ADVERSE EFFECTS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11285423 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K031361. One submission often covers many models, so check the product and lot details in each record.
- Z-0962-2023 · Dec 9, 2022 · Open, ClassifiedCADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24
- Z-0148-2022 · Jul 14, 2020 · TerminatedCADD Administration Sets, Model #21-7346-24
- Z-2589-2017 · May 15, 2017 · TerminatedCADD High Volume Administration Set with FlowStop, 21-7381-24. Product Usage: The CADD High-Volume Administration set is designed for use with the CADD Prizm pump to allow fluid
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 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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