Medex BBF26Recalls & 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
- 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 10351688512017), received between Oct 7, 2017 and Oct 7, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- Hypoxia1
- Neonatal Deformities1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 7, 2017Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS A DROP IN OXYGEN SATURATION FOLLOWING USE OF A MEDEX¿ MICRO BORE T-CONNECTOR. A CRITICALLY ILL PATIENT WAS ADMITTED AT BIRTH DIAGNOSED WITH SEVERE HEART DISEASE, MOST NOTABLY, NO IDENTIFIABLE RIGHT VENTRICULAR CAVITY. MEDICATION WAS BEING INFUSED INTO THE PATIENT TO MAINTAIN THE PATENCY OF THE DUCTUS ARTERIOSUS. THE DUCTUS ARTERIOSUS IS A BLOOD VESSEL CONNECTING THE MAIN PULMONARY ARTERY TO THE PROXIMAL DESCENDING AORTA. SHORTLY AFTER ADMISSION, THE PATIENT WAS NOTED TO HAVE A DROP IN OXYGEN SATURATION FROM THE LOW 90S DOWN TO THE HIGH 70S. CAREFUL INSPECTION OF THE PRODUCT NOTED A DROP OF FLUID BELOW THE HUB OF THE CONNECTOR. THE PRODUCT WAS CHANGED AND THE PATIENT'S OXYGEN SATURATION INCREASED BACK TO 94. THE PATIENT STABILIZED.
Patient problems: Hypoxia; Neonatal Deformities
MAUDE report 6926945 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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