MaxZero MZ5313Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885403471261), received between Nov 11, 2023 and Mar 12, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026Fluid/Blood Leak; Leak/Splash

  IT IS REPORTED TUBING APPEARED SEVERED WITH BLOOD AND IVFS LEAKING.

  Patient problems: Insufficient Information

  MAUDE report 24583634 ↗
• MalfunctionJan 29, 2026Separation Failure

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24218313 ↗
• MalfunctionJun 17, 2025Backflow; Backflow

  IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS LOOSE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT THIS PRODUCT IS TOO HEAVY WHICH DISLODGES IVS. THERE ARE 2 INJECTION PORTS WHICH HAS HIGHER RISK OF INFECTION. THE NEEDLELESS INJECTION PORT WAS LOOSE WHICH RESULTED IN BLOOD FLOWING BACK INTO THE PATIENT BED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235252 ↗
• MalfunctionJan 22, 2025Material Separation; Material Separation

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21209322 ↗
• MalfunctionJun 5, 2024Break; Break

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467030 ↗
• MalfunctionJun 4, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR(S) WAS LOOSE. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. 2 CAPS OF IV EXTENSION TUBING ARE VERY LOOSE. SOMETIMES THEY FALL OFF OR ARE EASILY INADVERTENTLY DISCONNECTED WHEN UNSCREWING IV TUBING, SYRINGE OR BLOOD COLLECTION DEVICE. THIS IS A CHANGE. WE ARE ACCUSTOMED TO MORE FIRMLY PLACE CAPS WHICH HAS RESULTED IN OPEN IV SITES, BLOOD SPILLAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19456198 ↗
• MalfunctionMay 20, 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: "WE'VE HAD TWO MICROBORE TUBING FAILURES IN PAST WEEK AND IT HAS BECOME A PATIENT SAFETY ISSUE. THE HUB HAS CRACKED DURING TWO TIVA CASES THIS WEEK, LEADING TO MEDICATION LEAKING TO THE GROUND RATHER THAN DELIVERY TO THE PATIENT. THESE EVENTS LED TO HEMODYNAMIC INSTABILITY, SURGERY STOPPAGE FOR TROUBLESHOOTING, AND A POSSIBLE INCREASE IN PATIENT AWARENESS. HAVE THESE ISSUES BEEN REPORTED BEFORE? I HAVE ATTACHED TWO IMAGES FROM THE CASE TODAY (ONE OF THE CRACK AT THE HUB; ANOTHER OF THE PACKAGING). I HAVE ATTACHED ONE VIDEO DEMONSTRATING FLUID LEAKING FROM THE CRACK. IT IS UNLIKELY TO BE USER ERROR AS BOTH LEAKAGES HAPPENED HOURS AFTER WE STARTED THE CASE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19356523 ↗
• MalfunctionMay 13, 2024Loss of or Failure to Bond; Leak/Splash; Loss of or Failure to Bond; Leak/Splash

  MATERIAL# MZ5313 BATCH# UNKNOWN IT WAS REPORTED BY CUSTOMER THAT THE Y-SET BROKE OFF IN HALF. VERBATIM: "TODAY WE USED THE NEW I.V. Y -SET ON A TRAUMA PT. WHEN WE WENT TO CT, DURING THE CONTRAST INFUSION, THE Y-SET BROKE OFF IN HALF AS SEEN IN THE PICTURES. I EXPERIENCED IT ONCE AND THE CT TECH. (B)(6) HAD SEEN IT 2 TIMES. IT DELAYED US FROM DOING THE CT. WE HAD TO CAREFUL REPLACE THE Y- SET WITH A SINGLE IV. CONNECTION. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19300383 ↗
• MalfunctionApr 22, 2024

  DEVICE BROKE IN HALF DURING A CT (COMPUTED TOMOGRAPHY) CONTRAST INFUSION AND HAD TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19163792 ↗
• InjuryNov 11, 2023Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL#: (B)(4) BATCH NUMBER#: 23089289, UNKNOWN IT WAS REPORTED BY CUSTOMER THAT THERE ARE A COUPLE OF INCIDENTS THAT HAPPENED IN THE ER. THE END USERS ARE REPORTING: ¿ I WALKED INTO A PATIENT ROOM AFTER HEARING AN ALARM FOR AN IV PUMP GO OFF. I OBSERVED THAT THE INFUSION WAS COMPLETE AND WENT TO TURN OFF THE PUMP. I SAW A SIGNIFICANT AMOUNT OF BLOOD ON THE FLOOR AND PATIENT BED. AS I INSPECTED THE IV SITE, I NOTICED THAT ONE OF THE PORTS ON THE Y TUBING HAD COME OFF RESULTING IN THE MEDICATION THAT WAS INFUSING ON THE OTHER PORT PUSHING THE MEDICATION AND BLOOD OUT OF THE OTHER SIDE OF THE TUBING. ¿ FLUSHING HEP LOCK WITH NS, LINE AND HUB BOTH HAD BLOOD, WHILE FLUSHING LINE FLUSH POPPED OFF SPLASHING FACE AND LEFT EYE. ¿ ER NURSES ARE COMPLAINING THAT IT'S HARD TO DRAW BLOOD. VERBATIM#: , REACHING OUT IF YOU CAN PROVIDE MORE LIVE EDUCATION TO THE ER STAFF. THERE ARE SOME CONCERNS AND UNSATISFACTORY FEEDBACK ABOUT THE IV EXTENSION. WHAT ARE YOUR AVAILABILITIES? I WALKED INTO A PATIENT ROOM AFTER HEARING AN ALARM FOR AN IV PUMP GO OFF. I OBSERVED THAT THE INFUSION WAS COMPLETE AND WENT TO TURN OFF THE PUMP. I SAW A SIGNIFICANT AMOUNT OF BLO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18117158 ↗