Deltec 21-2735-24Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10610586015861), received between Mar 2, 2022 and Aug 14, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K870866); 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Air/Gas in Device2
- Device Damaged Prior to Use1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT WHEN THE CLAMP WAS OPENED, THE HOSE DREW IN AIR, DESPITE PREVIOUSLY BEING AIR-FREE AND FLUSHED. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY. THE INCIDENT TOOK PLACE RIGHT AT THE START OF USING THE PRODUCT, INVOLVING HEALTHCARE PROFESSIONALS, AND OCCURRED AT THE PATIENT'S HOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19987220 ↗MalfunctionAug 14, 2024Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT WHEN THE CLAMP WAS OPENED, THE HOSE DREW IN AIR, DESPITE PREVIOUSLY BEING AIR-FREE AND FLUSHED. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY. THE INCIDENT TOOK PLACE RIGHT AT THE START OF USING THE PRODUCT, INVOLVING HEALTHCARE PROFESSIONALS, AND OCCURRED AT THE PATIENT'S HOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19981745 ↗MalfunctionApr 26, 2022Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED THAT THERE WAS BREAKAGE OF DELIVERY. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14207495 ↗MalfunctionMar 2, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE TUBE CAN NOT BE FILLED. PORT NEEDLE NOT PASSING / CLOGGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13652924 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K870866. One submission often covers many models, so check the product and lot details in each record.
- Z-0189-2020 · Jul 8, 2019 · TerminatedGRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL, GRIPPER, 22G X 1.25" (32MM), 12/BX; 3. NDL
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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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