Medex MX7827Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Medex (98)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10351688505187), received between Jan 17, 2024 and Jan 17, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Alarm System” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
3 other recalls cover devices cleared under the same FDA submission (K790408, K942377); 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
Recalls naming this device
- Sep 24, 2024Open, Classified
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
Z-0187-2025 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Alarm System1
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.
MalfunctionJan 17, 2024Device Alarm System; Device Alarm System
IT WAS REPORTED THAT THE TUBING SET OFF THE HIGH-PRESSURE ALARM IN THE PUMP. THE ALARM COULD NOT BE CLEARED NO MATTER HOW MANY TIMES THEY INCREASED THE PRESSURE LIMITS. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED. THE OUTCOME OF THE EVENT WAS REPORTED AS ONGOING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18527568 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K790408, K942377. One submission often covers many models, so check the product and lot details in each record.
- Z-0185-2025 · Sep 24, 2024 · Open, Classifiedmedex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
- Z-0186-2025 · Sep 24, 2024 · Open, Classifiedmedex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740
- Z-0184-2025 · Sep 24, 2024 · Open, Classifiedmedex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page