MaxZero MZ9265Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10885403240775), received between Jun 27, 2019 and May 29, 2026 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (10 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

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Crack

  IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT THEY CLAMPED PORT, DISCONNECTED FLUIDS AND UPON APPLYING A GREEN CUROS CAP TO THE BIFURCATE MALE CONNECTOR, THE BIFURCATE END CRACKED AROUND THE CUROS CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25326540 ↗
• MalfunctionFeb 25, 2026Complete Blockage

  THE EXTENSION SETS DON'T FUNCTION PROPERLY CAUSING LINE OCCLUSION WHEN DID THE INCIDENT OCCUR? DURING USE WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN NOT DIRECTLY (DELAY ON INFUSION OF THERAPY WILL AFFECT THE PATIENT) WAS ADDITIONAL MEDICAL INTERVENTION/MEDICATION REQUIRED? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24447242 ↗
• MalfunctionJan 21, 2026Infusion or Flow Problem

  FLUID STOPPED FLOWING INJURIES OR ADVERSE EVENT: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24136356 ↗
• MalfunctionJan 21, 2026Infusion or Flow Problem

  FLUID STOPPED FLOWING INJURIES OR ADVERSE EVENT: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24136355 ↗
• MalfunctionDec 1, 2025Crack; Crack

  IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT LEAKING BELOW THE HUB TOWARDS THE EXTENSION SET AND FOR CRACKING.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23680341 ↗
• MalfunctionSep 2, 2025Complete Blockage; Leak/Splash; Complete Blockage; Leak/Splash

  IT WAS REPORTED THAT BD MAXZERO EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT BI FUSE WAS DISCONNECTED FROM THE PORT AND FLUSHING WAS UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935417 ↗
• MalfunctionJul 28, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT MZ9265 FAILED TO PRIME OR ALLOW FLUID FLOW THROUGH THE MAXZERO ON TWO DIFFERENT BI-FUSE EXTENSION SETS. THE SET WITH THE LABELS "EPINEPHRINE" WAS USED IN THE PEDIATRIC ICU AND THE OTHER SET WAS USED IN THE ONCOLOGY UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628033 ↗
• MalfunctionJul 28, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT MZ9265 FAILED TO PRIME OR ALLOW FLUID FLOW THROUGH THE MAXZERO ON TWO DIFFERENT BI-FUSE EXTENSION SETS. THE SET WITH THE LABELS "EPINEPHRINE" WAS USED IN THE PEDIATRIC ICU AND THE OTHER SET WAS USED IN THE ONCOLOGY UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22628030 ↗
• MalfunctionJun 19, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONNECTION STARTED LEAKING AS SOON AS THE IVF AND NAHCO3 INFUSION WAS STARTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294238 ↗
• MalfunctionJun 19, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONNECTION STARTED LEAKING AS SOON AS THE IVF AND NAHCO3 INFUSION WAS STARTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294046 ↗
• MalfunctionJun 19, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONNECTION STARTED LEAKING AS SOON AS THE IVF AND NAHCO3 INFUSION WAS STARTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293828 ↗
• MalfunctionJun 19, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONNECTION STARTED LEAKING AS SOON AS THE IVF AND NAHCO3 INFUSION WAS STARTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22290057 ↗
• MalfunctionJun 19, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONNECTION STARTED LEAKING AS SOON AS THE IVF AND NAHCO3 INFUSION WAS STARTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22290055 ↗
• MalfunctionApr 30, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT WHILE ATTEMPTING TO DISCONNECT THE BIFUSE FROM THE ACCESS DEVICE, THE BIFUSE SNAPPED IN HALF CLOSER TO THE LUER ACCESS DEVICE. A PORTION OF THE BIFUSE TUBING REMAINED STUCK IN THE ACCESS DEVICE AND WAS UNABLE TO BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937910 ↗
• MalfunctionJul 25, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS UNDER INFUSING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: 2) MAXZERO SLOWS DOWN THE MEDICATION FLOW RATE. IF THE MEDICATION IS GIVEN WITHOUT MAXZERO, THE FLOW RATE IS QUITE FAST, WHILE AT THE SAME SETTING THE MEDICATION FLOW RATE GIVEN WITH MAXZERO IS QUITE SLOW. THIS ALSO HAPPENS WITH BOLUS MEDICATION. THE SYRINGES ENCOUNTER RESISTANCE. WHILE THE MEDICATION WAS BEING ADMINISTERED BY INFUSION PUMP, THE PUMP CONTINUOUSLY ALARMED FOR OBSTRUCTION. ALTHOUGH THE PORT CATHETER WAS NOT OCCLUDE, THE PUMP CONTINUED TO ALARM. THE MEDICATION THEREFORE TOOK 2,5 HOURS TO REACH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19824500 ↗
• MalfunctionApr 10, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR LEAKED AT THE CONNECTION SITE DURING THE PRIMING AND INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MICROBORE BI-FUSE EXTENSION SET LEAKED AT THE CONNECTION SITE DURING PRIMING AND INFUSION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16710173 ↗
• MalfunctionFeb 15, 2023Break; Break

  IT WAS REPORTED THAT THE BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR SNAPPED APART WHEN REMOVING IT FROM THE PACKAGING. THIS OCCURRED WITH 4 DIFFERENT SETS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD NUMEROUS PROBLEMS ON DIFFERENT PATIENTS WITH THEM BREAKING. WHILE OPENING PACKAGE AND PULLING BIFUSE OUT OF THE PACKAGING IT GOT CAUGHT AND EASILY SNAPPED APART. PULL ON OTHER SIDE OF BIFUSE TO SEE IF IT WOULD COME APART EASILY AS WELL AND IT DID."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16383679 ↗
• MalfunctionFeb 10, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR SNAPPED APART AND LEAKED OUT IVF AND CHEMO. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD MAXZERO LOT # 22045768 BIFUSE HAVE BEEN BREAKING SUPER EASILY. WE HAVE HAD NUMEROUS PROBLEMS ON DIFFERENT PATIENTS WITH THEM BREAKING. WHILE OPENING PACKAGE AND PULLING BIFUSE OUT OF THE PACKAGING IT GOT CAUGHT AND EASILY SNAPPED APART. PULLED ON THE OTHER SIDE OF BIFUSE TO SEE IF IT WOULD COME APART EASILY AND IT DID. IN ANY OF THE OCCURRENCES DID ANY LEAKAGE OCCUR? IF SO, WHAT LEAKED? IVF & CHEMO."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16348743 ↗
• MalfunctionFeb 10, 2023Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT THE BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR SNAPPED APART AND LEAKED OUT IVF AND CHEMO. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD MAXZERO LOT # 22045768 BIFUSE HAVE BEEN BREAKING SUPER EASILY. WE HAVE HAD NUMEROUS PROBLEMS ON DIFFERENT PATIENTS WITH THEM BREAKING. WHILE OPENING PACKAGE AND PULLING BIFUSE OUT OF THE PACKAGING IT GOT CAUGHT AND EASILY SNAPPED APART. PULLED ON THE OTHER SIDE OF BIFUSE TO SEE IF IT WOULD COME APART EASILY AND IT DID... IN ANY OF THE OCCURRENCES DID ANY LEAKAGE OCCUR? IF SO, WHAT LEAKED? IVF & CHEMO."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16348737 ↗
• MalfunctionFeb 10, 2023Material Separation; Material Separation

  IT WAS REPORTED WHILE USING BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) THE SET WAS BROKEN. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EXT SET IS BREAKING APART WHEN COMING OUT OF PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16346067 ↗
• MalfunctionSep 29, 2022Defective Component; Defective Component

  IT WAS REPORTED WHILE USING BD MICROBORE BI-FUSE EXTENSION SET, 2 IV CO THE TUBING SEPARATED FROM THE LUER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BI-TUBING EXTENSION BROKE AWAY FROM CONJUNCTION SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15506356 ↗
• MalfunctionMar 20, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 1 BD MAXZERO¿ EXTENSION SET WAS BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE USER REPORTED UNABLE TO USE THE DEVICE WITH CT CONTRAST AS THE EXTENSION SET WILL NOT ALLOW CONTRAST TO GO THROUGH WHICH HAS DELAYED CODE STROKE IN CT AND ALSO CAN NOT DRAW BLOOD FROM THE EXTENSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13830971 ↗
• MalfunctionJan 13, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE MICROBORE BI-FUSE EXTENSION SET, 2 IV CO EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: MZ9265 BATCH/LOT # UNKNOWN. RECENTLY I HAVE HAD TWO NURSES BRING ME TWO DIFFERENT PRODUCTS THAT WERE IN USE ON PATIENTS FAILED. ONE IS THE TRI-FUSE CONNECTOR, ONE OF THE ENDS CAME OFF (BROKEN BELOW LUER). THE OTHER IS THE 0.2 MICRON FILTER SET, LOW SORB, WHICH WAS LEAKING AT THE FILTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11168345 ↗
• MalfunctionJan 13, 2021Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE MICROBORE BI-FUSE EXTENSION SET, 2 IV CO EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: MZ9265 BATCH/LOT # 20066692. MAXZERO BI-FUSE WAS NOT ABLE TO BE FLUSHED THROUGH EITHER PORT. NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11163574 ↗
• MalfunctionOct 20, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT MICROBORE BI-FUSE EXTENSION SET, 2 IV CO HAD FOREIGN MATTER ON 12 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER ASKS IF THE YELLOW COLORATION IN MAXZERO CONNECTOR IS NORMAL, INFORMED THAT THE MATERIAL IN OKAY WITH EXPIRATION DATE. THE SALES REP THAT IDENTIFIED THE COLOR, THERE WAS NO PATIENT INVOLVEMENT AND ITS USAGE IS ONLY AS SELLING SAMPLE.

  Patient problems: No Patient Involvement

  MAUDE report 10703513 ↗