Medex M20178R2Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Medex (98)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10351688510785), received between Jul 6, 2017 and Jul 6, 2017 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (3 reports).
1 other recall cover devices cleared under the same FDA submission (K820355); 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.
Most reported problems
Device problems
- Device Misassembled During Manufacturing /Shipping3
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 6, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED THAT THE HIGH PRESSURE TUBING OF A MEDEX¿ LOGICAL® 3 GANG MANIFOLD WAS NOT BONDED ON THE PROPER SIDE OF THE MANIFOLD. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6690896 ↗MalfunctionJul 6, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED THAT THE HIGH PRESSURE TUBING OF A MEDEX LOGICAL 3 GANG MANIFOLD WAS NOT BONDED ON THE PROPER SIDE OF THE MANIFOLD. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6690884 ↗MalfunctionJul 6, 2017Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED THAT THE HIGH PRESSURE TUBING OF A MEDEX LOGICAL 3 GANG MANIFOLD WAS NOT BONDED ON THE PROPER SIDE OF THE MANIFOLD. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6690876 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K820355. One submission often covers many models, so check the product and lot details in each record.
- Z-0739-2024 · Nov 10, 2023 · Open, ClassifiedMedex LOGICAL CATH LAB KIT, List Number M20754
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- ACUMEN IQ SENSOR AIQS6AZ5Edwards Lifesciences LLC · Transducer, Blood-Pressure, Extravascular1 recall1 report
- Acumen IQ AIQS8R5Edwards Lifesciences LLC · Transducer, Blood-Pressure, Extravascular1 recall1 report
- ACUMEN IQ SENSOR AIQS6AZEdwards Lifesciences LLC · Transducer, Blood-Pressure, Extravascular1 recall0 reports
- Acumen IQ AIQS6REdwards Lifesciences LLC · Transducer, Blood-Pressure, Extravascular1 recall0 reports
- Acumen IQ AIQS6Edwards Lifesciences LLC · Transducer, Blood-Pressure, Extravascular1 recall0 reports
- Medex M20754Icu Medical, Inc. · TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR1 recall0 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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