MaxZero MZ9278Recalls & reported problems
BD Switzerland Sàrl · Microbore tri-fuse extension set, 3 IV connectors, 3 check valves, 15 cm (6 in) · Class 2
All models of MaxZero (47)
Data updated Oct 16, 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 10885403240812), received between Mar 31, 2023 and Mar 28, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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.
Reports received per month
Most reported problems
Device problems
- Loose or Intermittent Connection1
- Separation Problem1
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.
MalfunctionMar 28, 2025Separation Problem; Separation Problem
IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF THE BLUE CONNECTORS FELL OFF THE LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21723942 ↗MalfunctionMar 31, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR TUBING SEPARATED AT THE BLUE JOINT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "TUBING COMES OFF VERY EASILY (AT THE BLUE JOINT BETWEEN THE MANUAL CLAN AND THE JUNCTION OF THE 3 TUBINGS) SEEN BEFORE CONNECTION TO THE BB, THEREFORE WITHOUT CONSEQUENCE BUT COULD HAVE BEEN VERY SERIOUS EVENT THAT ALREADY HAPPENED A SHORT TIME AGO IN THE DEPARTMENT TOOK ANOTHER OCTOPUS AND CHECK BEFORE INSTALLATION".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16659525 ↗
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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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