Neusite NC5001RRecalls & reported problems
Icu Medical, Inc. · Class 2
Data updated Oct 18, 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 15019517133226), received between Apr 1, 2021 and May 18, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Disconnection2
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2021Detachment of Device or Device Component
IV DISCONNECTED WHEN USING A SMALL BORE. THIS HAS HAPPENED MULTIPLE TIMES AND ALREADY REPORTED TO FDA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11840855 ↗MalfunctionApr 26, 2021Disconnection
IV'S DISCONNECTED DURING MECHANICAL PRESSURE INJECTION. TWO WERE REPORTED TO BE SMALL BORE, ONE REGULAR. THIS HAS OCCURRED ON SEVERAL DIFFERENT OCCASIONS - ESTIMATED PATIENT # TO BE AT LEAST 50. THIS HAS BEEN REPORTED FOR SMALL, STANDARD AND LARGE BORES.
Patient problems: Insufficient Information
MAUDE report 11723317 ↗MalfunctionApr 26, 2021Disconnection
IV DISCONNECTED DURING MECHANICAL POWER INJECTION. THIS HAS BEEN ONGOING SINCE 2017. REPORTED >10 CASES TOTAL. SUBMITTED A REPORT THAT INVOLVED >5 INCIDENTS LAST MONTH. THIS REPORT INCLUDES 7 MORE INCIDENTS.
Patient problems: Insufficient Information
MAUDE report 11722893 ↗MalfunctionApr 1, 2021Detachment of Device or Device Component
4 INSTANCES OF NEUSITE SMALL BORE DISCONNECTING DURING POWER INJECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11602007 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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