MaxZero MZ9294Recalls & reported problems
BD Switzerland Sàrl · Microbore bi-fuse extension set, 2 removable IV connectors, filter 18 cm (7 in) · Class 2
All models of MaxZero (47)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885403417900), received between Feb 18, 2025 and Feb 17, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash5
- Fluid/Blood Leak3
- Complete Blockage1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2026Fluid/Blood Leak
NO ADDITIONAL INFORMAITON PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370724 ↗MalfunctionFeb 17, 2026Fluid/Blood Leak; Leak/Splash
NO ADDITIONAL INFORMAITON PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24370722 ↗MalfunctionSep 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT LEAKAGE AROUND THE SEALED CIRCULAR FILTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23069295 ↗MalfunctionApr 17, 2025Complete Blockage; Leak/Splash; Complete Blockage; Leak/Splash
IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT TRIFUSE WAS LEAKING AT SAME FILTER LOCATION AS BIFUSES. I DO NOT HAVE THE PRODUCT PACKAGING FOR THE TRIFUSE SO I AM UNABLE TO PROVIDE A LOT NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21859800 ↗MalfunctionMar 16, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD ANOTHER MAZZERO BIFUSE MALFUNCTION AND ALSO A TRIFUSE. TRIFUSE WAS LEAKING AT SAME FILTER LOCATION AS BIFUSES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21615626 ↗MalfunctionFeb 18, 2025Leak/Splash; Leak/Splash
AA CODE WAS UPDATED FROM FLOW ISSUES - FLUID BLOCKAGE TO LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21403695 ↗MalfunctionFeb 18, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21403375 ↗
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
- 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