MaxZero MZ5304Recalls & reported problems
BD Switzerland Sàrl · Pressure rated extension set, removable IV connector 18 cm (7.0 in) · Class 2
Quick summary
This BD MaxZero pressure-rated extension set is a removable IV connector for intravenous administration. Reports mostly describe leaks, material separation, and connection problems, including difficulty flushing or aspirating, with most not linked to patient symptoms; 5 mention bleeding. There are 91 reports, including 1 death and no injuries, and no recalls name this device. Report volume rose from 13 to 44 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 94
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 10885403230578), received between Sep 17, 2018 and Sep 18, 2026 — classified as 1 death, 93 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (36 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
- Leak/Splash36
- Fluid/Blood Leak14
- Connection Problem12
- Material Separation10
- Disconnection9
- Loose or Intermittent Connection5
- Separation Problem4
- Device Contamination with Chemical or Other Material3
Patient problems
- No Clinical Signs, Symptoms or Conditions76
- Hemorrhage/Blood Loss/Bleeding5
- Insufficient Information4
- No Consequences Or Impact To Patient3
- No Information3
- No Known Impact Or Consequence To Patient2
- Cardiac Arrest1
- Hemolysis1
Recent adverse event reports
The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Disconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50823214 ↗MalfunctionSep 18, 2026Disconnection
Patient problems: Insufficient Information
MAUDE report 50819872 ↗MalfunctionSep 16, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792541 ↗MalfunctionSep 16, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792540 ↗MalfunctionSep 16, 2026Difficult to Flush
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792539 ↗MalfunctionSep 16, 2026Difficult to Flush
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50792538 ↗MalfunctionSep 11, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744360 ↗MalfunctionSep 11, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744359 ↗MalfunctionSep 11, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744355 ↗MalfunctionSep 9, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50702909 ↗MalfunctionSep 9, 2026Disconnection
It was reported that BD maxzero needless connector had connection issues.The following information was received by the initial reporter with the following Verbatim.It was reported by the customer that the tubing has become detached from the needle on three separate occasions.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50681904 ↗MalfunctionSep 3, 2026Infusion or Flow Problem
It was reported that BD Maxzero needless connector had flow issuesThe following information was received by the initial reporter with the following Verbatim No specific Lot #s have been provided because it is a widely perceived issue.Lack of securement causes leaking, air in line, hemolysis, and difficulty aspirating/flushing.
Patient problems: Hemolysis
MAUDE report 50577642 ↗MalfunctionJun 30, 2026Leak/Splash
IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT MAXZERO LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25668593 ↗MalfunctionJun 4, 2026Obstruction of Flow
IT WAS REPORTED THAT THE BD MAXZERO PRESSURE RATED EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONCE NURSES GET AN IV ON A PATIENT AND CONNECT THE EXTENSION SET, THEY ARE NO LONGER ABLE TO FLUSH OR PULL BACK BLOOD. WHEN USING A DIFFERENT KIT, THIS IS NOT A PROBLEM. WE HAD APPROXIMATELY 10 INCIDENTS BEFORE WE FIGURED OUT WHAT WAS THE PROBLEM. I DON¿T HAVE EXACT DATES, BUT IT WOULD HAVE BEEN DURING THE LAST 2 WEEKS. WE TURNED IN ALL IV KITS WITH THAT LOT NUMBER, ONCE WE FIGURED OUT THAT THE OTHER LOT NUMBER ON THE FLOOR WAS WORKING. THERE WAS PATIENT INVOLVEMENT, AS THEY HAD TO BE STUCK MORE THAN ONCE DUE TO THE MALFUNCTIONING IV SET. THESE WERE NOT FULLY DOCUMENTED AS WE DID NOT KNOW WHAT WAS HAPPENING UNTIL THERE WAS A PATTERN. THE ONLY THING THAT AFFECTED PATIENTS WAS HAVING TO BE STUCK MORE THAN ONCE DUE TO NOT KNOWING WHY THE LINE WOULDN¿T WORK. BATCH#: POSSIBLE LOTS#(25085164, 25085052, 25075006, 25085530).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25399874 ↗MalfunctionApr 29, 2026Disconnection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25029946 ↗MalfunctionApr 28, 2026Disconnection
IT WAS REPORTED THAT THE BD MAXPLUS PRESSURE RATED EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PER THE CUSTOMER "THE CONNECTION BETWEEN IV CATHETER AND THE J-LOOP BECOMES DISCONNECTED. THIS EVENT HAS OCCURRED ON MULTIPLE UNITS ACROSS BOTH CAMPUSES. THERE WERE 3 INCIDENTS ON 5 WEST THAT NURSING TOLD ME ABOUT AND 2 INCIDENTS ON 4 WEST. THE ISSUE WE ARE HAVING IS THAT WE DO NOT HAVE THE INITIAL PACKAGING BECAUSE IT IS NOT OCCURRING AT THE TIME OF PLACEMENT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25024238 ↗MalfunctionApr 21, 2026Fluid/Blood Leak; Leak/Splash; Difficult to Open or Close
IT IS REPORTED, BD MAXZERO TUBING LEAKING UNDER DRESSING AT CONNECTION TO IV CATHETER. BD MAXZERO TUBING IS VERY DIFFICULT TO CLAMP AND UNCLAMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24943441 ↗MalfunctionApr 13, 2026Incomplete or Inadequate Connection
IT WAS REPORTED THAT THE BD MAXZERO PRESSURE RATED EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED SEVERAL PRODUCT COMPLAINTS FROM OUR DEPARTMENTS REGARDING ITEM MZ5304, PLEASE SEE BELOW. THE COMPLAINTS CONSISTED OF A VARIETY OF LOT NUMBERS. THEY ARE DISCONNECTING OR NOT CONNECTING SECURELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24867214 ↗MalfunctionApr 13, 2026Nonstandard Device
IT WAS REPORTED THAT THE BD MAXZERO PRESSURE RATED EXTENSION SET HAD A DAMAGED / DEFECTIVE CLAMP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED SEVERAL PRODUCT COMPLAINTS FROM OUR DEPARTMENTS REGARDING ITEM MZ5304, PLEASE SEE BELOW. THE COMPLAINTS CONSISTED OF A VARIETY OF LOT NUMBERS. SLIDE CLAMP IS DIFFICULT TO USE ESPECIALLY WHEN STARTING IV¿S AND DRAWING BLOODWORK. THE CLAMP DOES NOT SLIDE EASILY AND THE CLAMP SOMETIMES WONT CLAMP AT ALL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24867110 ↗MalfunctionApr 13, 2026Material Separation
IT WAS REPORTED THAT THE BD MAXZERO PRESSURE RATED EXTENSION SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE RECEIVED SEVERAL PRODUCT COMPLAINTS FROM OUR DEPARTMENTS REGARDING ITEM MZ5304, PLEASE SEE BELOW. THE COMPLAINTS CONSISTED OF A VARIETY OF LOT NUMBERS. TUBING CAME APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24867109 ↗MalfunctionMar 10, 2026Leak/Splash; Separation Failure
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24561346 ↗MalfunctionMar 2, 2026Obstruction of Flow
IT WAS REPORTED THAT THE BD MAXZERO PRESSURE RATED EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATES MZ 5304 WOULDN'T DRAW BLOOD FROM AN IV, CHANGED TO A NEW ONE AND BLOOD WAS DRAWN WITHOUT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24492560 ↗MalfunctionFeb 25, 2026Complete Blockage
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24448039 ↗MalfunctionFeb 4, 2026Fluid/Blood Leak; Material Separation
IT WAS REPORTED THAT THE BD MAXZERO PRESSURE RATED EXTENSION SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ORIGINAL ISSUE WAS THE STIFFNESS OF THE COLLAR WHICH LED TO DIFFICULTIES WITH CONNECTING IT TO THE CATHETER HUB. OF LATE STAFF HAVE BEEN NOTING THAT THEY ARE BEING CALLED TO TROUBLESHOOT LEAKING IVS AND FINDING THAT THE COLLAR IS LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24264499 ↗MalfunctionFeb 4, 2026Loose or Intermittent Connection
NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24264497 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.