Deltec 21-3261-24Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10610586029844), received between Jul 13, 2020 and Jan 23, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Obstruction of Flow1
- Premature Separation1
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.
MalfunctionJan 23, 2026Obstruction of Flow
IT WAS REPORTED THAT THE ITEM CANNOT BE FLUSHED WITH NACL, AND IT CAN BE FLUSHED THROUGH ONLY WITH VIOLENT FORCE. THE ISSUE OCCURRED THREE TIME WITH THE SAME RESULT. THE DEVICE MALFUNCTION WAS DISCOVERED WHEN SAMPLES WERE TO BE TAKEN FROM A PORT-A-CATHETHER. AS THE DEVICE COULD NOT BE USED, THE SAMPLES HAD TO BE TAKEN INTRAVENOUSLY INSTEAD THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24161635 ↗MalfunctionJul 13, 2020Premature Separation; Premature Separation
INFORMATION WAS RECEIVED INDICATING THAT UPON REMOVAL OF A SMITHS MEDICAL DELTEC GRIPPER MICRO NEEDLE FROM A PATIENT, THE SAFETY FUNCTION DID NOT WORK. IT WAS REPORTED THAT THE UPPER PART OF THE NEEDLE DETACHED WITHOUT RESISTANCE LEADING TO A NEEDLE STICK TO THE CLINICIAN. SINCE THE NEEDLE WAS CONTAMINATED, THE CLINICAL STAFF'S BLOOD WAS TAKEN. THERE WERE NO REPORTED ADVERSE EFFECTS.
Patient problems: Needle Stick/Puncture
MAUDE report 10267771 ↗
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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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