DUO-VENT ACT5435Recalls & reported problems
Baxter Healthcare Corporation · Solution Set with DUO-VENT Spike, Injection Site, Male Luer Lock Adapter with Retractable Collar · Class 2
All models of DUO-VENT (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00085412079684), received between Mar 20, 2018 and Jul 17, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
- Fitting Problem1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT A SOLUTION SET WITH DUO-VENT SPIKE HAD A CUT IN THE TUBE. THE ISSUE WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17333218 ↗MalfunctionApr 5, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT BLACK PARTICULATE MATTER WAS OBSERVED IN THE CHAMBER AREA OF THIRTY-FOUR (34) SOLUTION SETS WITH DUO-VENT SPIKE; THIS WAS FURTHER DESCRIBED AS ¿BLACK SPECS¿. THE WAS OBSERVED PRIOR USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11614156 ↗MalfunctionMar 20, 2018Fitting Problem; Fitting Problem
IT WAS REPORTED THAT AN INTERLINK SECONDARY MEDICATION SET WOULD NOT CONNECT TO THE ACCESS PORT OF A SOLUTION SET. DURING SETUP, THE CUSTOMER WAS UNABLE TO PUNCTURE THE PORT OF THE PRIMARY SOLUTION SET WITH THE SECONDARY SET. THIS EVENT OCCURRED DURING PATIENT INFUSION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7355611 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page