enFlow 980121EURecalls & reported problems
Carefusion Corporation · enFlow™ Controller Model 121 · Class 2
- 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 10885403296819), received between Dec 4, 2018 and Dec 16, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Emits Odor” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Device Emits Odor2
Patient problems
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2019Device Emits Odor; Device Emits Odor
THE CUSTOMER REPORTED THAT A BURNT SMELL WAS NOTICED ON THE ENFLOW CONTROL UNIT. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED IN THIS EVENT.
Patient problems: No Patient Involvement
MAUDE report 9475113 ↗MalfunctionDec 4, 2018Device Emits Odor; Device Emits Odor
CUSTOMER REPORTED THE ENFLOW CONTROLLER UNIT EXPLODED WITH A BURNING SMELL. THE ISSUE OCCURRED ON SET UP PRIOR TO PATIENT-USE. THE CUSTOMER REPORTED THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.
Patient problems: No Patient Involvement
MAUDE report 8129188 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.