MaxZero MZ5301Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10885403230547), received between Jul 2, 2019 and Mar 23, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (9 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Disconnection; Separation Problem

  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 THEY HAD A CLAVE (MZ1000-07) THAT BROKE OFF A J-LOOP (MZ5301) WHILE TRYING TO FLUSH A PERIPHERAL IV AFTER A BLOOD TRANSFUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24671064 ↗
• MalfunctionFeb 25, 2025Leak/Splash; Material Separation; Leak/Splash; Material Separation

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21459970 ↗
• MalfunctionFeb 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT MULTIPLE REPORTS OF LEAKING TUBING DESPITE FIRMLY CONNECTING THE DISTAL END OF THE DEDICATED ALARIS TUBING TO THE EXTENSION SET.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21442772 ↗
• MalfunctionJan 10, 2025Blocked Connection; Blocked Connection

  IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT USER REPORTS OCCLUSION ALARM ON THE BD ALARIS INFUSION SYSTEM WHEN PERFORMING A MASS TRANSFUSION USING THE BD MAX ZERO CONNECTOR WITH BELMONT MACHINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21126504 ↗
• MalfunctionSep 24, 2024Leak/Splash; Leak/Splash

  MATERIAL#: MZ5301, BATCH#: 24049080. IT WAS REPORTED BY CUSTOMER THAT THESE ENDS ALWAYS LEAVE A BUBBLE OF FLUID ON THE END, AND THEY HAD BLOOD CLOT WITH THESE CONNECTORS. RCC RECEIVED A COMPLAINT VIA EMAIL. WE HAVE HAD CONCERNS BROUGHT TO US REGARDING THESE CONNECTORS AND THE CONNECTORS THAT HAVE THE SAME ENDS BUT NO EXTENSION TUBING. I WILL TRY TO INCLUDE SOME OF THE CONCERNS IN THIS EMAIL. WE ARE WONDERING IF THERE IS AN ALTERNATIVE PRODUCT WE COULD TRY? WE HAVE A CONCERN WITH THESE. TODAY WE HAD OUR RADIATION SAFETY MEETING AND IT WAS BROUGHT TO OUR ATTENTION BY NUC. MEDICINE THAT THESE ENDS ALWAYS LEAVE A BUBBLE OF FLUID ON THE END. IN NM THIS IS RADIOACTIVE AND CAN LEAD TO CONTAMINATION OF THE AREA. WE CAN SEE AN INCREASE IN DOSE TO OUR TECHNOLOGIST (THEY WEAR A RADIATION BADGE ON THEIR FINGER TO MONITOR THE DOSE FROM HANDLING THE SYRINGES)-WE ARE THINKING SOME OF THAT IS DUE TO THE DRIP OF LIQUID THAT FALLS ONTO THEIR GLOVES. I ALSO WANT TO INCLUDE THE BLOOD CLOT WE HAD WITH THESE CONNECTORS. THESE CONNECTORS HAVE BEEN BROUGHT UP BY MY STAFF AS A CONCERN ON 3CC. THEY HAVE STATED THAT THE TUBING DIAMETER IS SMALL AND IT CAUSES DIFFICULTIES WHEN TRYING TO ADMINISTER SOME PUSH M

  Patient problems: Insufficient Information

  MAUDE report 20295974 ↗
• MalfunctionSep 13, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: NURSES ARE FINDING WHEN THEY ADMINISTER CHEMOTHERAPY, WHICH CAN BE A THICKER DRUG, THE MX5301 IS GETTING BLOCKED. THEY HAD PREVIOUSLY BEEN USING A BAXTER HEALTHCARE CLEARLINK STANDARD BORE 15CM EXTENSION SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20218401 ↗
• MalfunctionAug 22, 2024Component Missing; Component Missing

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20026438 ↗
• MalfunctionJul 2, 2024Defective Component; Manufacturing, Packaging or Shipping Problem; Defective Component; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR WAS MISSING CLAMP. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING .VERBATIM: IT WAS REPORTED BY CUSTOMER THAT MISSING CLAMP. VERBATIM: MISSING CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660236 ↗
• MalfunctionJun 10, 2024Backflow; Backflow

  IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR(S) WAS BACKFLOWING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: CUSTOMER REPORTS THAT THE EXTENSION SET CONNECTED WAS CONNECTED TO IV HUB, BLOOD WAS PULLED OUT, THEN STOPPED AND WOULD NOT FLUSH. WHEN DISCONNECTED FROM IV HUB, BLOOD FREELY FLOWED FROM IV. STAFF MEMBERS REPORT MULTIPLE INCIDENTS OF THE SAME THING HAPPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19507151 ↗
• MalfunctionJan 30, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610211 ↗
• MalfunctionApr 12, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT 300 OF THE BD MAXZERO¿ EXTENSION SET WAS DIFFICULT TO DISCONNECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SWEDISH TO ENGLISH: LUER LOCK CONNECTOR GETS STUCK ON THE CVK. NEED INSTRUMENT TO DISCONNECT MZ 5301. CUSTOMER SEES A DIFFERENCE FROM OLDER PRODUCTS AND EXPERIENCES DIFFERENCE FOR THE WORSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728982 ↗
• MalfunctionMar 29, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD MAXZERO¿ EXTENSION SET WAS BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TODAY I WAS USING THE BD MAXZERO MINIBORE PRESSURE RATED EXTENSION SET IV CONNECTOR AND I COULD NOT PRIME IT. EVERY TIME I TRIED TO FLUSH THERE WAS RESISTANCE. I CHECKED THE CLAMP NUMEROUS TIMES TO ENSURE IT WAS OPEN, THE PREFILLED SYRINGE I WAS USING TO PRIME WAS FINE. FOR SOME ODD REASON FLUID DIDN'T SEEM TO MAKE IT PAST THE BLUE PRESSURE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16640531 ↗
• MalfunctionDec 30, 2022Leak/Splash; Air/Gas in Device; Leak/Splash; Air/Gas in Device

  IT WAS REPORTED THAT THE BD MAXZERO¿ EXTENSION SETS EXPERIENCED AIR BUBBLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: ON (B)(6) 2023, IN THE PERIOPERATIVE INTENSIVE CARE UNIT, DURING THE INSTALLATION OF AN INFUSION, THE NURSING TEAM NOTICED THE PRESENCE OF AIR BUBBLES AFTER THE 6-VALVE MANIFOLD (REF. RBP6315 - LOT 22F20-TJBNP) ON WHICH BIDIRECTIONAL VALVES ARE MOUNTED. THE LEAK APPEARS TO BE COMING FROM ONE OF THE VALVES THAT IS BEING REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16080945 ↗
• MalfunctionOct 11, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR LEAKED SALINE WHEN REMOVING THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NURSE HAVE A LUER SLIP SYRINGE WITH SALINE, ON A MZ5301 AND AT THE END OF IT SHE TAKES THE SYRINGE OFF, AND THERE COMES SMALL STINK OF SALINE IN HER FACE AND EYES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15581104 ↗
• MalfunctionSep 16, 2022Defective Device; Defective Device

  IT WAS REPORTED WHILE USING BD MINIBORE PRESSURE RATED EXT, IV CNNCTOR THE TUBING WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SINCE THE CONVERSION TO THIS NEW ITEM WE GET PUSH BACK BECAUSE OF THE LENGTH OF THE PORT AND HAVE TO OPEN ANOTHER PACKAGE TO ADD A PORT TO MAKE IT LONG ENOUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15442287 ↗
• MalfunctionAug 29, 2022Material Separation; Material Separation

  IT WAS REPORTED WHILE USING MAXZERO¿ EXTENSION SET, 1 MAXZERO¿ NEEDLE-FREE CONNECTOR SPIN MALE LUER LOCK THE DEVICE WAS DIFFICULT TO UNSCREW. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SWEDISH TO ENGLISH: LOT NO/BATCH NO: SEVERAL, UNKNOWN + 21095727 + 21095723. THE SPINNER COLLAR CAN NOW SLIP DOWN TO THE OTHER END OF THE HOSE. DIFFICULT TO UNSCREW WITH WET FINGERS - MUST BE POSITIONED EXACTLY RIGHT TO FIND THE PASSAGE (JUST SPINS LOOSE OTHERWISE). STUCK ¿> NEED TO USE PEN ON CVK TO GET IT OFF. RISK OF CRACKING THE CVK & RISK OF CONTAMINATING THE CVK WHEN YOU KEEP & FIDDLE TO GET IT OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15317506 ↗
• MalfunctionAug 29, 2022Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR MALE LUER GOT STUCK ON THE CATHETER, AND AN INSTRUMENT WAS NEEDED TO DISCONNECT IT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LUER LOCK CONNECTOR GETS STUCK ON THE CVK. NEED INSTRUMENT TO DISCONNECT MZ5301. CUSTOMER SEES A DIFFERENCE FROM OLDER PRODUCTS AND EXPERIENCES DIFFERENCE FOR THE WORSE. [...] THE PRODUCT'S LUER CONNECTION CAN BE PASSED BACKWARDS ON THE TUBE... THE CUSTOMER THINKS THERE IS A RISK OF DECONTAMINATION AND A RISK OF SEPSIS... [... ]THE CUSTOMERS ARE VERY CONCERNED REGARDING THE NEW SPIN LUERS ON THE MAXZERO EXTENSIONS BECAUSE THEY CAN VERY EASILY BE REMOVED BACK ON THE TUBING AND EVENTUALLY BE STUCKED SO THEY HAVE TO USE A PEANG TO GET IT OFF... [...] THE CUSTOMERS ARE VERY CONCERNED THE NEW SPIN LUERS ON THE MAXZERO EXTENSIONS BECAUSE THEY VERY EASILY CAN BE REMOVED BACK ON THE TUBING. THIS HAS EARLIER (2014) CAUSED SOME SERIOUS INCIDENTS (ICN330920) WHERE THE EXTENSION HAS BEEN STUCKED INTO THE CATHETER AND HAS NOT BEEN ABLE TO BE REMOVED. THE LUER WAS CHANGED SHORTLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15317045 ↗
• MalfunctionAug 29, 2022Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR MALE LUER GOT STUCK ON THE CATHETER, AND AN INSTRUMENT WAS NEEDED TO DISCONNECT IT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LUER LOCK CONNECTOR GETS STUCK ON THE CVK. NEED INSTRUMENT TO DISCONNECT MZ5301. CUSTOMER SEES A DIFFERENCE FROM OLDER PRODUCTS AND EXPERIENCES DIFFERENCE FOR THE WORSE. [...] THE PRODUCT'S LUER CONNECTION CAN BE PASSED BACKWARDS ON THE TUBE... THE CUSTOMER THINKS THERE IS A RISK OF DECONTAMINATION AND A RISK OF SEPSIS... [... ]THE CUSTOMERS ARE VERY CONCERNED REGARDING THE NEW SPIN LUERS ON THE MAXZERO EXTENSIONS BECAUSE THEY CAN VERY EASILY BE REMOVED BACK ON THE TUBING AND EVENTUALLY BE STUCKED SO THEY HAVE TO USE A PEANG TO GET IT OFF... [...] THE CUSTOMERS ARE VERY CONCERNED THE NEW SPIN LUERS ON THE MAXZERO EXTENSIONS BECAUSE THEY VERY EASILY CAN BE REMOVED BACK ON THE TUBING. THIS HAS EARLIER (2014) CAUSED SOME SERIOUS INCIDENTS (ICN330920) WHERE THE EXTENSION HAS BEEN STUCKED INTO THE CATHETER AND HAS NOT BEEN ABLE TO BE REMOVED. THE LUER WAS CHANGED SHORTLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15316969 ↗
• MalfunctionJul 14, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD MAXZERO¿ EXTENSION SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TUBING CONNECTION WAS LEAKING FROM WHERE IT CONNECTED TO THE IV CATHETER HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15019319 ↗
• MalfunctionJul 9, 2021Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT THE MINIBORE PRESSURE RATED EXT, IV CNNCTOR EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NICU HAVING ISSUES WITH THE MAXZERO CONNECTORS WHEN INFUSING LIPIDS. GETTING ¿HIGH PRESSURE¿ ALERTS WHEN INFUSING LIPIDS WITH MAXZERO CONNECTORS. ALSO HAVING TO CHANGE OUT THE MAXZERO CONNECTORS AFTER INFUSING LIPIDS DUE TO RESIDUAL LEFT IN THE CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12147333 ↗
• MalfunctionDec 29, 2020Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT THE MINIBORE PRESSURE RATED EXT, IV CONNECTOR WAS BLOCKED/OCCLUDED AND COULDN'T APPLY FLUIDS. THIS OCCURRED 50 SEPARATE TIMES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER WASN'T ABLE TO APPLIED FLUIDS OVER CONNECTOR. AFTER DISCONNECTING INFUSION WAS POSSIBLE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11089400 ↗
• MalfunctionOct 5, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE MINIBORE PRESSURE RATED EXT, IV CNNCTOR EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: MZ5301, BATCH NO.: 19035723. NURSE CALLED TO ADVISE THAT LOT #19035723 IS LEAKING AT THE MAX ZERO OR BLUE PART WHEN IT IS CONNECTED TO THE CADD OR GRAVITY TUBING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10632445 ↗
• MalfunctionAug 15, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT MINIBORE PRESSURE RATED EXT, IV CNNCTOR AND TUBING'S DISCONNECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: MZ5301, BATCH #: 20025156. IT WAS REPORTED THAT TWO PRIMARY TUBING'S DISCONNECTED FROM THE T-CONNECTOR. NET T-CONNECTOR FOR IV'S IN USE THIS MORNING TWO PRIMARY TUBING'S FOUND TO DISCONNECT FROM THE T-CONNECTOR ON PEDIATRIC PATIENT. SCREW TOGETHER PIECES AND FOUND TO UNSCREW SLOWLY BETWEEN T PIECE AND PRIMARY TUBING. NO INJURY NOTED TO PATIENT. FLUIDS INFUSING WERE NS AND D5NS WITH K; IT TOOK ABOUT 30 MINUTES FOR THE TUBING TO UNSCREW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10411772 ↗
• MalfunctionApr 15, 2020Break; Fluid/Blood Leak; Insufficient Device Problem Information; Break; Fluid/Blood Leak; Insufficient Device Problem Information

  MULTIPLE DISPOSABLE PRODUCTS (RECEIVED ATTACHED TO EACH OTHER) WERE RETURNED UNEXPECTEDLY, AND IT WAS REPORTED THAT MAJORITY OF THE PRODUCTS HAVE THE SAME REOCCURRING ISSUE OF BREAKING, CRACKING OR LEAKS. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: No Information

  MAUDE report 9964632 ↗
• MalfunctionFeb 12, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE REPORTED FEEDBACK SUGGESTS THAT THERE WAS A LEAKAGE. FROM THE REPORTED INFORMATION THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PATIENT OR USER AS A RESULT OF THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9699706 ↗