Deltec 21-2715-24Recalls & 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
- 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 10610586015793), received between Sep 12, 2022 and Sep 12, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (3 reports).
1 other recall cover devices cleared under the same FDA submission (K870866); 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
- Material Twisted/Bent3
- Material Too Soft/Flexible2
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.
MalfunctionSep 12, 2022Material Twisted/Bent; Material Too Soft/Flexible; Material Twisted/Bent; Material Too Soft/Flexible
IT WAS REPORTED THAT THE NEEDLE SEEMED SOFT AND BENT AT THE SIDE SLIGHTLY. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15403460 ↗MalfunctionSep 12, 2022Material Twisted/Bent; Material Too Soft/Flexible; Material Twisted/Bent; Material Too Soft/Flexible
IT WAS REPORTED THAT THE NEEDLE SEEMED SOFT AND BENT AT THE SIDE SLIGHTLY. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15402981 ↗MalfunctionSep 12, 2022Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE NEEDLE SEEMED SOFT AND SLIGHTLY BENT AT THE SIDE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15402915 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K870866. One submission often covers many models, so check the product and lot details in each record.
- Z-0189-2020 · Jul 8, 2019 · TerminatedGRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL, GRIPPER, 22G X 1.25" (32MM), 12/BX; 3. NDL
Other Set, administration, intravascular devices
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- 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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