MaxGuard MX9182Recalls & reported problems
BD Switzerland Sàrl · Extension set, and needleless Y-site 20 cm (8 in) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 10885403424304), received between Jun 30, 2026 and Aug 17, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Backflow” (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.
Reports received per month
Most reported problems
Device problems
- Backflow2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2026Backflow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50287846 ↗MalfunctionJun 30, 2026Backflow
IT WAS REPORTED THAT THE BD MAXGUARD EXTENSION SET W/ NEEDLELESS Y-SITE HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS REPORTED ISSUES OF THE BACKCHECK VALVE ON THE MX9182 NOT WORKING CORRECTLY. HE HAS SAVED THE SAMPLE AND HAS THE LOT # INFORMATION AS WELL. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: COULD YOU PLEASE PROVIDE A DETAILED DESCRIPTION OF THE ISSUE YOU ENCOUNTERED WITH BACKCHECK VALVE ON THE MX9182? WE IDENTIFIED AN ISSUE WITH THE BACKCHECK VALVE¿S INTENDED ONE WAY VALVE. WHEN SLIGHT POSITIVE PRESSURE IS APPLIED ON THE BACKCHECK SIDE OF THE VALVE SUCH AS DURING MEDICATION INFUSION, FLUSHING, OR MANUAL INJECTION THROUGH A LUER-LOCK ACCESS PORT THE VALVE DOES NOT CONSISTENTLY PREVENT RETROGRADE FLOW. UNDER THESE CONDITIONS, THE APPLIED PRESSURE APPEARS TO BYPASS THE VALVE DIAPHRAGM, ALLOWING FLUID TO TRAVEL BACKWARD INTO THE UPSTREAM LINE. THIS OCCURS WITH MINIMAL FORCE, CONSISTENT WITH NORMAL FLUSHING OR MEDICATION ADMINISTRATION, AND DOES NOT REQUIRE EXCESSIVE PRESSURE. AS A RESULT, THE VALVE FAILS TO RELIABLY MAINTAIN DIRECTIONAL FLOW AS DESIGNED. THIS BEHAVIOR CREATES THE POTENTIAL FOR UNINTENDED BACKFLOW INTO THE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25667849 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 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