Deltec 21-2768-24Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10610586025617), received between Jul 26, 2017 and Apr 1, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (3 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 16, 2026.
Most reported problems
Device problems
- Mechanical Problem3
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED THE DEVICE SAFETY MECHANISM "BROKE OFF" AND SO THE SAFETY MECHANISM DID NOT WORK. NO ADVERSE EFFECTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11606354 ↗MalfunctionApr 1, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED THE DEVICE SAFETY MECHANISM "BROKE OFF" AND SO THE SAFETY MECHANISM DID NOT WORK. NO ADVERSE EFFECTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11606347 ↗MalfunctionApr 1, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED THE DEVICE SAFETY MECHANISM "BROKE OFF" AND SO THE SAFETY MECHANISM DID NOT WORK. NO ADVERSE EFFECTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11606345 ↗MalfunctionJul 26, 2017Break; Break
IT WAS REPORTED THAT AFTER REMOVING A DELTEC® GRIPPER PLUS® SAFETY HUBER NEEDLE AND SNAPPING IN THE SAFETY DEVICE, THE NEEDLE BROKE FROM THE PLASTIC/FOAM PLATE AFTER ABOUT 30 SECONDS. THE PORT NEEDLE WAS NO LONGER SECURED. NO INJURY TO PATIENT OR CLINICIAN WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6745044 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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