Deltec 21-2760-24Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10610586025532), received between Aug 18, 2017 and Aug 20, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Complete Blockage” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Complete Blockage1
- Fail-Safe Design Failure1
Patient problems
- Needle Stick/Puncture1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2024Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THEY HAVE ACCESSED A BRISK BLOOD RETURN AND RAN PREMED OF 5ML AND COULD NO LONGER FLUSH. REACCESSED AND HAD NO FURTHER ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20007994 ↗InjuryAug 18, 2017Fail-Safe Design Failure; Adverse Event Without Identified Device or Use Problem; Fail-Safe Design Failure; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING USE OF THIS GRIPPER PLUS® SAFETY NEEDLE, UPON REMOVAL OF THE DEVICE, THE LOCKING MECHANISM DID NOT CLICK, THE SHARP WAS NOT CONTAINED, AND THE CLINICIAN WAS STUCK WITH THE NEEDLE. THIS DEVICE WAS USED TO ADMINISTER AN INFUSION OF CHEMOTHERAPY. A PRESSURE DEVICE WAS NOT USED IN CONJUNCTION. THE EVENT IS BEING DEALT WITH IN HOSPITAL AS PER POLICY. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Needle Stick/Puncture
MAUDE report 6804976 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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