Medfusion 3000CALRecalls & reported problems
Icu Medical, Inc. · Class 2
All models of Medfusion (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10610586031823), received between Nov 4, 2025 and Nov 4, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (1 report).
1 other recall cover devices cleared under the same FDA submission (K982640); 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
- Device Difficult to Program or Calibrate1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 4, 2025Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
IT WAS REPORTED THAT THE CALIBRATION APPEARED TO BE OFF ON THE DEVICE. THE FORCE DIAL FDK-20 METER THAT IS PART OF THE 3000CAL CALIBRATION KIT IS NOT WORKING PROPERLY AND IS NOT ACCURATE IN ITS MEASUREMENTS. THE UNIT IS VERY HARD TO PRESS AND DOES NOT ZERO AS IT SHOULD. ISSUE HAS BEEN PRESENT SINCE RECEIVING THE UNIT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23465027 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K982640. One submission often covers many models, so check the product and lot details in each record.
- Z-0768-2007 · Feb 3, 2007 · TerminatedMedfusion 3500 Syringe Infusion Pump with PharmGuard Medication safety Software versions 4.1.3 and 4.1.4. Medex, 4350 Green Parkway, Suite 200. Duluth, GA 30096
Other Pump, infusion devices
- Alaris 8100Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths650,218 reports
- Alaris 8100Carefusion 303, Inc. · Pump, infusion4 recalls78 deaths344,514 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion2 recalls45 deaths148,093 reports
- BD® Alaris™ Pump Module, Model 8100Carefusion 303, Inc. · Pump, infusion5 recalls30 deaths51,256 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls4 deaths21,956 reports
- Alaris 8110Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths15,547 reports
- Alaris 8015Carefusion 303, Inc. · Pump, infusion3 recalls6 deaths13,022 reports
- CADD 21-6500-51Icu Medical, Inc. · Pump, infusion2 deaths8,231 reports
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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