Deltec 21-2860-24Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10610586025648), received between May 16, 2017 and May 23, 2017 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Protective Measures Problem” (4 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
- Protective Measures Problem4
Patient problems
- No Consequences Or Impact To Patient3
- Needle Stick/Puncture1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2017Protective Measures Problem; Protective Measures Problem
IT WAS REPORTED THAT THE SAFETY MECHANISM OF A DELTEC® GRIPPER PLUS® SAFETY NEEDLE FAILED DURING USE. THE NURSE WAS ABLE TO GET THE SAFETY "BACK TO WHERE IT'S SUPPOSED TO BE". NO INJURY TO PATIENT OR CLINICIAN WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6584783 ↗MalfunctionMay 16, 2017Protective Measures Problem; Protective Measures Problem
IT WAS REPORTED THAT THE SAFETY MECHANISM OF A DELTEC® GRIPPER PLUS® SAFETY NEEDLE FAILED. THE FAULT OCCURRED WHEN DE-ACCESSING THE NEEDLE FROM THE PATIENT'S PORT. THE NEEDLE RAPIDLY PROTRUDED PAST THE PROTECTIVE COVERING. NO NEEDLE STICK OCCURRED. NO INJURY TO PATIENT OR CLINICIAN WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6570582 ↗MalfunctionMay 16, 2017Protective Measures Problem; Protective Measures Problem
IT WAS REPORTED THAT THE SAFETY MECHANISM OF A DELTEC® GRIPPER PLUS® SAFETY NEEDLE FAILED. THE FAULT OCCURRED WHEN DE-ACCESSING THE NEEDLE FROM THE PATIENT'S PORT. THE NEEDLE RAPIDLY PROTRUDED PAST THE PROTECTIVE COVERING. NO NEEDLE STICK OCCURRED. NO INJURY TO PATIENT OR CLINICIAN WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6570480 ↗InjuryMay 16, 2017Protective Measures Problem; Protective Measures Problem
IT WAS REPORTED THAT NEEDLE SHIELD OF A DELTEC® GRIPPER PLUS® SAFETY NEEDLE DID NOT COVER THE NEEDLE AS IT WAS SUPPOSED TO, LEAVING THE NEEDLE OUTSIDE THE SHIELD. "EE" HAD FLUSHED THE PORT WITH NS AND HEPARIN. CLINICIAN STABILIZED THE PORT AND WAS RETRACTING THE NEEDLE WHEN THEY WERE STUCK IN THE RIGHT THUMB. CLINICIAN WENT TO EMPLOYEE HEALTH TO HAVE IT CHECKED OUT. LAB WORK AND RISK COUNSELING WAS DONE. NO PERMANENT INJURY WAS REPORTED, AND THE EVENT WAS REPORTED AS RESOLVED.
Patient problems: Needle Stick/Puncture
MAUDE report 6570474 ↗
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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- 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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