Deltec 21-2864-24Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Deltec (97)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10610586025686), received between Nov 5, 2024 and Nov 12, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
1 other recall cover devices cleared under the same FDA submission (K021999); 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
- Fluid/Blood Leak1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 12, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE THE NURSE WAS FLUSHING THE LINE WITH SALINE AFTER THE LAB DRAW, THE NEXUS ON THE Y-SITE OPENED UP AND SPLASHED BLOOD ONTO THE FLOOR (APPROX. 3ML). THE EVENT OCCURRED DURING INFUSION. THIS HAS OCCURRED MULTIPLE TIMES ACROSS THE HEALTH SYSTEM. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20668681 ↗MalfunctionNov 5, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS SPRAYING AND LEAKING FROM THE NEXUS TKO AND ONELINK NEEDLELESS CONNECTORS WHEN PLACED AT THE NON-AFFIXED, NON-POWER Y-SITE GRIPPER PLUS PORT NEEDLE. THE LEAKING/SPRAYING OCCURRED FROM THE SEPTUM OF THE NEXUS TKO, AND THE ONELINK LEAKED FROM THE THREADED CONNECTION POINT. THE EVENT OCCURRED DURING INFUSION WHILE THE NURSE WAS FLUSHING FROM THE LOWER PORTION OF THE PORT NEEDLE EXTENSION, AND SALINE SPLASHED ONTO THE NURSE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20610047 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K021999. One submission often covers many models, so check the product and lot details in each record.
- Z-0253-2020 · Jul 15, 2019 · TerminatedPort full Access Tray Product Code: DT19330
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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