Deltec 21-3257-24Recalls & 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 10610586029806), received between May 5, 2021 and May 21, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A PATIENT ARRIVED AT THE PEDIATRIC EMERGENCY DEPARTMENT AT APPROXIMATELY 2030 WITH LEAKAGE OBSERVED FROM THE PORT TUBING WHILE A HOME BLINATUMOMAB INFUSION WAS RUNNING. THE LEAKAGE WAS IDENTIFIED AT THE BOTTOM OF THE PORT NEEDLE LINE BEFORE CONNECTION TO THE CHEMOTHERAPY ADAPTER, AND THE INFUSION WAS CLOSELY MONITORED AND SUBSEQUENTLY PAUSED AT APPROXIMATELY 2125 FOR PORT REACCESS. BLOOD RETURN WAS VERIFIED, AND BLINATUMOMAB WAS RESTARTED AT 2145 AT A RATE OF 5 ML PER HOUR BY S. MORRIS, RN, AND D. HOPKINS, RN. THE LEAKING PORT NEEDLE HAD BEEN PLACED AT THE OUTPATIENT CLINIC ON 20-APR-26, AND THE CLINIC NEEDLE WAS RETAINED WITH THIS REPORT. THERE WAS A PATIENT INVOLVEMENT WITH NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25243173 ↗MalfunctionMay 5, 2021Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT WHILE A NURSE TRIED TO REMOVE GRIPPER MICRO TO REMOVE NEEDLE AFTER PORT ACCESS BUT WAS UNABLE TO DO SO. A SECOND NURSE ATTEMPTED WITHOUT SUCCESS SO THE LINE WAS REMOVED AND A NEW NEEDLE USED TO ACCESS WITHOUT ISSUES. TRIED TO PULL BACK TO RELEASE GRIPPER AFTER IT WAS REMOVED FROM PATIENT BUT STILL WAS UNSUCCESSFUL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11781488 ↗
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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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