MaxZero MZ9289Recalls & reported problems
BD Switzerland Sàrl · Microbore extension set, removable, IV connector, filter 16 cm (6 in) · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885403417863), received between Sep 16, 2025 and Dec 4, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak2
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2025Leak/Splash; Leak/Splash
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 THE TPN TUBING FILTER LEAKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23723066 ↗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 23069300 ↗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 23069294 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.