MaxGuard MX4410Recalls & reported problems
BD Switzerland Sàrl · 15 Drop Administration Set, with 2 Needleless Y-Sites and 4-Way Stopcock 368 cm (145 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 10885403237454), received between Oct 8, 2019 and Oct 8, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component Missing” (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.
Most reported problems
Device problems
- Component Missing2
Patient problems
- No Information1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 8, 2019Component Missing; Component Missing
IT WAS REPORTED THAT DURING PRIMING, IT WAS OBSERVED THAT THE SET WAS MISSING THE ROLLER CLAMP. THE EVENT OCCURRED IN THE ENDOSCOPY UNIT. AN INCOMPLETE EVENT DATE SEPTEMBER REPORTED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9168709 ↗MalfunctionOct 8, 2019Component Missing; Component Missing
IT WAS REPORTED THAT THE SET WAS MISSING A HUB ON THE END OF THE TUBING. ALTHOUGH REQUESTED, NO FURTHER PATIENT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER. THE EVENT OCCURRED IN THE (SAC) SURGICAL ACUTE CARE UNIT.
Patient problems: No Information
MAUDE report 9168111 ↗
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- 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.
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