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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 · Terminated
    Port full Access Tray Product Code: DT19330

Other Set, administration, intravascular devices

All Set, administration, intravascular devices →

Sources and updates

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