Nexus TKO® NX4650Recalls & reported problems
Nexus Medical, LLC · Nexus TKO®-6P Anti-Reflux Luer Activated Device · Class 2
Data updated Oct 18, 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 10892855000505), received between Jun 2, 2025 and Jun 3, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Backflow” (2 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. 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
- Backflow2
- Fluid/Blood Leak1
- Flushing Problem1
- Infusion or Flow Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2025Fluid/Blood Leak; Flushing Problem; Infusion or Flow Problem
BLOOD WAS FOUND ON THE NEXUS TKO CAP TRAPPED BETWEEN THE CAMP AND WHERE THE LINE MEETS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22131222 ↗MalfunctionJun 2, 2025Backflow
THE NURSE WAS CALLED TO THE BEDSIDE BY THE PATIENT FAMILY AS THEY NOTICED THAT THERE WAS BLOOD INSIDE THE NEXUS IV CAP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22122296 ↗MalfunctionJun 2, 2025Backflow
BLOOD IN THE NEXUS TKO ATTACHED TO THE RED LUMEN AFTER LABS WERE DRAWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22122277 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page