Medex SM5009Recalls & reported problems
Icu Medical, Inc. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10351688500595), received between Jan 2, 2020 and Jan 2, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Component Missing” (1 report).
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
- Component Missing1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 2, 2020Component Missing
MULTIPLE DEVICES MISSING FLOW CONTROL CONTROLLER. FDA SAFETY REPORT ID # (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9540487 ↗
Other Filter, infusion line devices
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- NA 2N3350Baxter International Inc. · Filter, infusion line33 reports
- Medex FS116Icu Medical, Inc. · Filter, infusion line30 reports
- Medex MX448HFBIcu Medical, Inc. · Filter, infusion line27 reports
- INTERLINK 1C8740Baxter International Inc. · Filter, infusion line10 reports
- NA 2N3342Baxter International Inc. · Filter, infusion line8 reports
- FLUID SYSTEMS ACCESSORIES 2N3368Baxter Healthcare Corporation · Filter, infusion line5 reports
- Medex FS113Icu Medical, Inc. · Filter, infusion line3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.