INTERLINK/DUO-VENT 2H6480Recalls & reported problems
Baxter Healthcare Corporation · Non-DEHP Solution Set with DUO-VENT Spike, 0.2 Micron Downstream Filter, Injection Site, Male Luer Lock Adapter with Retractable Collar · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00085412048512), received between Oct 8, 2024 and Oct 8, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K153158); 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF NON-DEHP SOLUTION SETS HAD WHITE DISCOLORATION OR A BLEMISH INSIDE THE TUBING, NEAR THE FILTER. SOME OF THE WHITE DISCOLORATION (SUBSTANCE) COULD BE SCRAPED OFF THE TUBING. THIS WAS OBSERVED WHEN RETRIEVING THE SETS FROM THE CASES, PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20403748 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K153158. One submission often covers many models, so check the product and lot details in each record.
- Z-0196-2026 · Aug 29, 2025 · Open, ClassifiedCLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2
- Z-0195-2026 · Aug 29, 2025 · Open, ClassifiedCLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch (2.6 meters), Product Code 2C8
Other Set, administration, intravascular devices
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- 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.
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