Deltec 21-3277-24Recalls & 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 10610586029943), received between Jul 20, 2022 and Jul 20, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).
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
- Fluid/Blood Leak2
- Blocked Connection1
- Failure to Infuse1
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.
MalfunctionJul 20, 2022Failure to Infuse; Blocked Connection; Failure to Infuse; Blocked Connection
IT WAS REPORTED THAT THE CUSTOMER WAS EXPERIENCING BLOOD GETTING STUCK AT THE Y-SITE, REQUIRING RE-ACCESS TO THAT PATIENT. NO PATIENT INJURY OR ADVERSE AFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15067112 ↗MalfunctionJul 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE CUSTOMER WAS EXPERIENCING LEAKING AT THE Y-SITE REQUIRING RE-ACCESS TO THAT PATIENT. NO PATIENT INJURY OR ADVERSE AFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15066922 ↗MalfunctionJul 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE CUSTOMER WAS EXPERIENCING LEAKING AT THE Y-SITE REQUIRING RE-ACCESS TO THAT PATIENT. NO PATIENT INJURY OR ADVERSE AFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15066874 ↗
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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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