Deltec 21-2868-24Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Deltec (97)
Data updated Oct 18, 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 10610586025723), received between Mar 22, 2017 and Mar 22, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).
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 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak2
- Protective Measures Problem2
Patient problems
- Injury2
- Tissue Damage2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 22, 2017Fluid/Blood Leak; Protective Measures Problem; Fluid/Blood Leak; Protective Measures Problem
IT WAS REPORTED THAT AFTER PATIENT USE OF THE DELTEC® GRIPPER PLUS® SAFETY NEEDLE SPLIT SEPTUM Y-SITE THE NURSE WAS UNABLE TO RETRACT THE NEEDLE INTO THE SAFETY MECHANISM. THE INCIDENT RESULTED IN CHEMOTHERAPY DRUG LEAKING ONTO THE PATIENT SKIN WHICH LEAD TO A SKIN INJURY. THE SKIN INJURY WAS TREATED WITH MEDICATION. NO PERMANENT ADVERSE EFFECT TO THE PATIENT WAS REPORTED. RELATED MFR #: 3012307300-2017-00680.
Patient problems: Injury; Tissue Damage
MAUDE report 6425583 ↗MalfunctionMar 22, 2017Fluid/Blood Leak; Protective Measures Problem; Fluid/Blood Leak; Protective Measures Problem
IT WAS REPORTED THAT AFTER PATIENT USE OF THE DELTEC® GRIPPER PLUS® SAFETY NEEDLE SPLIT SEPTUM Y-SITE THE NURSE WAS UNABLE TO RETRACT THE NEEDLE INTO THE SAFETY MECHANISM. THE INCIDENT RESULTED IN CHEMOTHERAPY DRUG LEAKING ONTO THE PATIENT SKIN WHICH LEAD TO A SKIN INJURY. THE SKIN INJURY WAS TREATED WITH MEDICATION. NO PERMANENT ADVERSE EFFECT TO THE PATIENT WAS REPORTED. RELATED MFR #: 3012307300-2017-00777.
Patient problems: Injury; Tissue Damage
MAUDE report 6425569 ↗
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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- 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.
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