INTERLINK/DUO-VENT 2C7452Recalls & reported problems
Baxter International Inc. · Secondary Medication Set with DUO-VENT Spike, Hanger, Lever Lock Cannula, Male Luer Lock Adapter · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00085412002583), received between Sep 23, 2019 and Dec 9, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “No Flow” (3 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- No Flow3
- Device Contamination with Chemical or Other Material1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT UNSPECIFIED UNITS OF INTERLINK SYSTEM SECONDARY MEDICATION SETS LEAKED FROM AN UNSPECIFIED LOCATION. THIS OCCURRED DURING UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23756516 ↗MalfunctionAug 15, 2022No Flow; No Flow
IT WAS REPORTED THAT THERE WAS NO FLOW THROUGH TWO (2) INTERLINK SYSTEM SECONDARY MEDICATION SETS. IT WAS NOT SPECIFIED WHEN IN THE PROCESS STEP THIS OCCURRED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15225124 ↗MalfunctionNov 24, 2021No Flow; No Flow
IT WAS REPORTED THAT TWO (2) INTERLINK SECONDARY MEDICATION SETS WOULD NOT FLOW. THIS OCCURRED DURING USE WITH A HUMAN ALBUMIN ELISA LABORATORY TEST KIT AT A LABORATORY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12870955 ↗MalfunctionJul 8, 2020No Flow; No Flow
IT WAS REPORTED THAT AN INTERLINK SYSTEM SECONDARY MEDICATION SET WOULD NOT FLOW DURING SETUP AND PREPARATION. IT WAS FURTHER REPORTED THAT THE SET WAS USED TO DELIVER INTRAVENOUS (IV) ANTIBIOTICS. IN ORDER TO RESOLVE THE ISSUE A NEW SET WAS USED WITH NO ISSUES NOTED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10246423 ↗MalfunctionSep 23, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED CONTAMINANTS WERE OBSERVED INSIDE "THE CANNULA" OF AN INTERLINK VENTED SECONDARY MEDICATION SET. THIS ISSUE WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 9107815 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.