MaxZero MZX5306Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10885403463792), received between Aug 13, 2024 and Apr 7, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Leak/Splash; Material Separation

  IT WAS REPORTED THAT THE BD MAXZERO PRESSURE RATED EXTENSION SET HAD SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAX ZERO IV EXTENSION SET WAS USED AS A CONNECTOR FROM AN IV TO A CONTINUOUS HEPARIN GTT. THIS PIGTAIL EXTENSION SET SPLIT IN HALF WHILE IN USE OVERNIGHT AND THE PATIENT WOKE UP WITH BLOOD ALL OVER HIS BED. HIS HEMOGLOBIN DROPPED OVER 2 POINTS. MODEL#: MZX5306.

  Patient problems: Anemia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24811057 ↗
• MalfunctionMar 2, 2026Separation Failure

  IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT " TESTED ONE TO SEE HOW MUCH FORCE I NEEDED TO PULL IT APART AND NEEDED TO PUT SOME STRENGTH INTO IT, THINKING MAYBE THE CONNECTION IS WEAK BUT IT IS PRETTY SOLID. IV SITE ITSELF REMAINED INTACT AND CONFIRMED THERE WAS NO PULLING OR MANIPULATING OF THE IV LINE"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491874 ↗
• MalfunctionFeb 26, 2026Connection Problem

  IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT PT WAS CONNECTED TO A CONTINUOUS HEPARIN DRIP AND THE PIGTAIL TUBING DISCONNECTED. THIS CAUSED THE IV TO LEAK BLOOD ALL OVER THE PATIENT AND HIS BED. THE PT AWOKE AND WAS COVERED IN BLOOD, WHICH ALARMED HIM (UNDERSTANDABLY), AND HE SAT UP AT THE BEDSIDE. THIS SET OFF THE BED ALARM WHICH ALERTED MULTIPLE RNS. UPON ARRIVAL TO THE ROOM, PT WAS NAKED AT BEDSIDE AND BLOOD WAS SATURATING THE PT, LINENS, BED AND SURROUNDING FLOOR. PT WAS ASSISTED BACK TO BED AND ~30 MINUTES WAS SPENT CLEANING UP THE PT AND EQUIPMENT. PT STATED HE HAD NOT MESSED WITH THE IV AND WASN'T SURE WHAT HAPPENED. AFTER THE PT WAS STABLE AND CLEANED UP, RN ASSESSED THE IV FURTHER AND REALIZED IV WAS STILL IN PLACE BUT THE PIGTAIL TUBING WAS SPLIT IN HALF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24462005 ↗
• MalfunctionFeb 10, 2026Disconnection; Connection Problem

  IT IS REPORTED DISCONNECTION. DESCRIPTION: "BD MAXZERO EXT SET, LOT#: 25095854 MALFUNCTIONING. BUFF CATHETER POPPED OFF AFTER CONNECTION TO IV CATHETER. PLEASE TRACK FOR TRENDING CONCERNS. NO HARM TO PATIENT OR STAFF." ADDITIONAL INFORMATION: THE BLUE BUFF CAP CAME OFF THE EXTENSION SET CAUSING BLOOD TO LEAK FROM THE PATIENT'S IV CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305425 ↗
• MalfunctionJan 29, 2026Disconnection

  IT IS REPORTED DISCONNECTION. VERBATIM: PATIENT HAD AN IV WITH THIS MAX ZERO EXTENSION SET ATTACHED. THEY WERE IN THE MIDDLE OF A PROCEDURE, COVERED UNDER A STERILE DRAPE, WHEN THE MAX ZERO CAME DISCONNECTED FROM THE EXTENSION SET LEAVING THE TUBE OF THE EXTENSION SET ENTIRELY OPENED WHICH LED TO 300ML BLOOD LOSS FROM PATIENT. PATIENT MOVED TO OCU FOR MONITORING DUE TO BLOOD VOLUME LOST. ENDED UP BEING OK.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24209113 ↗
• MalfunctionDec 22, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE BD MAXZERO PRESSURE RATED EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN RADIOLOGY DURING A CT EXAM WITH CONTRAST INJECTION THE HUB COMES UNDONE WITH PRESSURE OF THE CONTRAST INJECTION. PRIOR TO INJECTION OF THE CONTRAST THE IV IS TESTED WITH NORMAL SALINE WITHOUT ISSUE. NURSING & CT TECHS HAVE BEEN INSTRUCTED TO TIGHTEN THE HUBS AS FIRMLY AS POSSIBLE. WITH THIS INSTRUCTION INCIDENTS HAVE DECREASED. HOWEVER, ON OCCASION THE CT TECH HAS REPORTED THAT EVEN AFTER THEY TIGHTENED THE HUB FIRMLY THEY VISUALIZED THE HUB COME LOOSE AND DISCONNECT UNDER THE PRESSURE OF THE CONTRAST INJECTION. PRODUCT INFORMATION: MANUFACTURER: BD MAXZERO. REFERENCE: MZX5306. LOT #: 25095062. HOW MANY TIMES HAS THIS OCCURRED? NUMEROUS TIMES OVER THE PAST THREE MONTHS. WHAT IS THE DATE(S) OF EVENT? I DO NOT HAVE ALL OF THE DATES AT THIS TIME. NEXT WEEK WHEN THE QUALITY TEAM HAS RETURNED FROM THE HOLIDAY I WILL BE ABLE TO COLLECT THE NUMBER AND DATES OF OCCURRENCE FROM OUR EVENT REPORTING SYSTEM. WERE THERE ANY ADVERSE EVENTS DUE TO THIS ISSUE? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23872303 ↗
• MalfunctionDec 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE CLAVE IS POPPING OFF OF THE EXTENSION SET AFTER BEING DISCONNECTED FROM THE PT CAUSE BLOOD TO BACK FLOW OUT OF THE IV.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23764652 ↗
• MalfunctionDec 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE CLAVE IS POPPING OFF OF THE EXTENSION SET AFTER BEING DISCONNECTED FROM THE PT CAUSE BLOOD TO BACK FLOW OUT OF THE IV.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23764646 ↗
• MalfunctionSep 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BD MAXZERO EXTENSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN FLUSHING THE LINE THE EXTENSION SET LEAKED FROM BENEATH THE WHITE CAP ON THE EXTENSION SET.

  Patient problems: Exposure to Body Fluids

  MAUDE report 23044605 ↗
• MalfunctionJun 16, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM MATERIAL #MZX5306 LOT #UNKNOWN IT WAS REPORTED BY CUSTOMER THAT HE J-LOOP AND THEN THE COLLECTION DEVICE. HE WENT TO GRAB HIS TUBES AND REALIZED THAT THERE WAS BLOOD EVERYWHERE. THE J-LOOP HAD COMPLETELY BROKE AWAY FROM THE Y-SITE, WHICH THEN CAUSED BLOOD TO RUN OUT OF THE J-LOOP. THIS PATIENT WAS BEING HELD DOWN BY STAFF AND SECURITY AS HE WAS PLACED IN RESTRAINTS AND BECAUSE OF THIS MALFUNCTION IN THE TUBING, XXX HAD SOME DROPS OF BLOOD LAND ON HIS ARM. WE HAD TO DISCONNECT THE BROKEN J-LOOP FROM THE CATHETER HUB AND RECONNECT A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214510 ↗
• MalfunctionAug 13, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD 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 EXTENSION SET WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19969956 ↗
• MalfunctionAug 13, 2024Material Separation; Material Separation

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19969924 ↗