MaxZero MZ5309Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10885403242083), received between Jun 5, 2018 and Jan 5, 2026 — classified as 53 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (15 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 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Separation 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 THE CUSTOMER THAT SEPARATION OF SPIN COLLAR FROM TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23966369 ↗
• MalfunctionJan 5, 2026Separation 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 THE CUSTOMER THAT TUBING SEPARATED FROM SPIN COLLAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23966335 ↗
• MalfunctionDec 29, 2025Material Separation; Material Separation

  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 SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918809 ↗
• MalfunctionDec 8, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET WAS SEAPRATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY A CUSTOMER THAT THE TUBING SEPARATED FROM THE SPIN COLLAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751968 ↗
• MalfunctionNov 21, 2025Material Separation; Material Separation

  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 DURING CT POWER INJECTION, THERE WAS SEPARATION AT THE HUB/SPIN COLLAR CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23621817 ↗
• MalfunctionNov 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BD MAXZERO PRESSURE RATED EXTENSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: DID THE ISSUE HAPPEN DURING PATIENT USE? IF YES, WAS THERE ANY INJURY? ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. YES, THE ISSUE OCCURRED DURING CONTRAST INJECTION FOR A CT SCAN. NO SERIOUS INJURY. THE TEST WAS STOPPED AND THE J LOOP TUBING WAS REMOVED AND A SALINE LOCK APPLIED TO THE IV CATHETER. THE PATIENT WAS THEN CLEANED UP AS THERE WAS CONTRAST ON THE PATIENT AND THEN THE TEST WAS RESUMED. WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? IOHEXOL, IODINATED CONTRAST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23590793 ↗
• MalfunctionNov 16, 2025Crack; Crack

  IT WAS REPORTED THAT THE BD MAXZERO PRESSURE RATED EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAXZERO CRACKED WITH VACUTAINER CONNECTION ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? ON (B)(6) 2025, AT 1345 IN (B)(6) ADULT ED. WHILE STARTING AN IV ON A PATIENT. 10ML SYRINGE WAS ATTACHED TO THE DISTAL END OF THE EXTENSION SET BEFORE ATTACHING THE PROXIMAL END TO THE ANGIOCATH NEEDLE HUB. WHEN BLOOD RETURN ENTERED THE EXTENSION TUBING SET, THE CONNECTION TUBING POPPED OFF AND FELL INTO THE BED. THE HUB REMAINED CONNECTED TO THE ANGIOCATH ALLOWING FREE FLOW OF BLOOD. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO ADVERSE EVENT FOR EITHER. WAS THERE ANY LEAK? YES. BLOOD WAS ABLE TO FREE-FLOW FROM THE ANGIOCATH THROUGH THE LUERLOCK COLLAR WHEN THE TUBING POPPED OFF. CAN YOU PLEASE PROVIDE THE MATERIAL AND LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? BD MAXZERO REF: MZ5309 LOT#: 25099006.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23565739 ↗
• MalfunctionOct 24, 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: THE MAXZERO J LOOP EXTENSION SETS ARE BLOWING APART PARTICULARLY WITH CTA WORK. THE CT TECHS HAVE REPORTED THIS TO ME THIS WEEK. I AM TOLD THIS HAS BEEN OCCURRING FOR APPROX. 2 MONTHS. THEY WERE HESITATE AT FIRST OF REPORTING THINKING IT WAS A ONE OFF OR AN ISOLATED INCIDENT. IT IS OCCURRING WITH PATIENTS FROM THE ER BUT ALSO THE OP EXAMS WHEN OUR CT STAFF IS STARTING THOSE IVS. THEY ASSURE ME THEY ARE CONNECTING CORRECTLY AND SCREWING IT DOWN TIGHTLY. IT SEEMS THIS MAY BE A REAL PROBLEM. THIS IS CAUSING SOME DELAYS IN TESTING AS THEY ARE HAVING TO REDOSE THE PATIENT WITH IV CONTRAST ALONG WITH A STICKY MESS TO CLEAN UP ON THE PATIENT AS WELL AS THE EXAM ROOM. WE HAVE REVERTED BACK TO SALINE LOCKS DIRECTLY TO THE HUB OF THE IV CATHETER AND NOT USING THE J LOOPS FOR NOW. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO SERIOUS INJURY HAS OCCURRED ALTHOUGH THE ADVERSE EVENT WOULD BE THAT THE PATIENTS ARE HAVING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23386586 ↗
• MalfunctionOct 24, 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: THE MAXZERO J LOOP EXTENSION SETS ARE BLOWING APART PARTICULARLY WITH CTA WORK. THE CT TECHS HAVE REPORTED THIS TO ME THIS WEEK. I AM TOLD THIS HAS BEEN OCCURRING FOR APPROX. 2 MONTHS. THEY WERE HESITATE AT FIRST OF REPORTING THINKING IT WAS A ONE OFF OR AN ISOLATED INCIDENT. IT IS OCCURRING WITH PATIENTS FROM THE ER BUT ALSO THE OP EXAMS WHEN OUR CT STAFF IS STARTING THOSE IVS. THEY ASSURE ME THEY ARE CONNECTING CORRECTLY AND SCREWING IT DOWN TIGHTLY. IT SEEMS THIS MAY BE A REAL PROBLEM. THIS IS CAUSING SOME DELAYS IN TESTING AS THEY ARE HAVING TO REDOSE THE PATIENT WITH IV CONTRAST ALONG WITH A STICKY MESS TO CLEAN UP ON THE PATIENT AS WELL AS THE EXAM ROOM. WE HAVE REVERTED BACK TO SALINE LOCKS DIRECTLY TO THE HUB OF THE IV CATHETER AND NOT USING THE J LOOPS FOR NOW. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO SERIOUS INJURY HAS OCCURRED ALTHOUGH THE ADVERSE EVENT WOULD BE THAT THE PATIENTS ARE HAVING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23386585 ↗
• MalfunctionSep 10, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD MAXZERO PRESSURE RATED EXTENSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT APPEARS THE TUBING CAUSED RADIATION TO BE EXPELLED BACK OUT OF THE LINE, RESULTING IN CONTAMINATION OF THE GOWN. THE CONTAMINATED GOWN HAD TO BE STORED IN RADIOACTIVE WASTE FOR DECAY. THERE WERE NO ADVERSE REACTIONS REPORTED FROM THE RADIATION EXPOSURE, AND THE MATERIAL HAS BEEN STORED FOR DECAY.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 23021010 ↗
• MalfunctionSep 9, 2025Separation Problem; 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 THE CUSTOMER THAT STARTING AN IV, AND WHEN THEY FLUSHED THE LINE, THEY NOTICED SALINE ON THE PATIENT¿S ARM. TURNS OUT, THE TUBING HAD COME APART. THIS IS NOT THE FIRST TIME THEY¿VE RUN INTO THIS ISSUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001504 ↗
• MalfunctionJul 3, 2025Separation Problem; Separation Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22401343 ↗
• MalfunctionJun 16, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: COULD YOU CONFIRM THE NUMBER OF CHILDREN AFFECTED? SEVERAL CHILDREN. COULD YOU CONFIRM THE IMPACT ON PATIENTS? TEMPORARY CONSEQUENCES (INCREASED PROCEDURE OR ANESTHESIA TIME). COMMERCIAL REFERENCE: (B)(4). BATCH NO.: 25019127. DATE OF OCCURRENCE: (B)(6) 2025. DESCRIPTION OF INCIDENT: IMPOSSIBLE TO INJECT.

  Patient problems: Insufficient Information

  MAUDE report 22212252 ↗
• MalfunctionJun 16, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: COULD YOU CONFIRM THE IMPACT ON PATIENTS? TEMPORARY CONSEQUENCES (INCREASED PROCEDURE OR ANESTHESIA TIME). COMMERCIAL REFERENCE: MZ5309 BATCH NO.: 25019127 DATE OF OCCURRENCE: (B)(6) 2025 DESCRIPTION OF INCIDENT: CLAMP IS HARD AND DAMAGES THE TUBING (SEE LEAK)

  Patient problems: Insufficient Information

  MAUDE report 22212216 ↗
• MalfunctionJun 16, 2025Reflux within Device; Reflux within Device

  IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR HAD BLOOD BACKFLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: COULD YOU CONFIRM THE IMPACT ON PATIENTS? TEMPORARY CONSEQUENCES (INCREASED PROCEDURE OR ANESTHESIA TIME). COMMERCIAL REFERENCE: MZ5309 BATCH NO.: 25019127 DATE OF OCCURRENCE:(B)(6) 2025 DESCRIPTION OF INCIDENT: NO REFLUX; LITTLE REFLUX.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 22212211 ↗
• MalfunctionJun 4, 2025Connection Problem; Connection 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 KEEP POPPING OFF AND LEAKING, IF IT IS NOT FULLY TIGHTENED WHEN STARTED IT WILL LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22145025 ↗
• MalfunctionJun 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT MAXZERO PRESSURE RATED EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT LEAKING MAXZERO IV CONNECTOR EXTENSION SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127477 ↗
• MalfunctionMay 12, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR WAS DIFFICULT TO CLAMP. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT THE CONNECTORS ARE DIFFICULT TO KEEP TIGHT WHERE THE TUBING IS CONNECTED TO THE IV CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002488 ↗
• MalfunctionApr 20, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR HAD BACK FLOW THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. APPROACHED ME TO THAT HE HAS HAD 2 IV'S IN A WEEK COME LOOSE WHERE THE TUBING IS CONNECTED TO THE IV CATHETER. I HUDDLED WITH PASS WHERE THEY PLACE THE MAJORITY OF THE IV'S AND THE STAFF SAID THAT THEY DO STRUGGLE WITH THE CONNECTORS AND THEY ALL REPORTED BLOOD BACKING UP IN THE TUBING AND STRUGGLING TO KEEP IT TIGHT. THEY HAVE NOTICED THAT THEY ARE HAVING MORE DIFFICULTY IN THE LAST 2 MONTHS. I DON'T KNOW IF ANY OTHER DEPARTMENTS ARE HAVING THE SAME ISSUES WITH THESE CONNECTORS. I DON'T KNOW IF THIS COULD BE LINKED TO A LOT # SO I TOOK A PICTURE OF THE FRONT AND BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21870321 ↗
• MalfunctionApr 20, 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: APPROACHED ME TO THAT HE HAS HAD 2 IV'S IN A WEEK COME LOOSE WHERE THE TUBING IS CONNECTED TO THE IV CATHETER. I HUDDLED WITH PASS WHERE THEY PLACE THE MAJORITY OF THE IV'S AND THE STAFF SAID THAT THEY DO STRUGGLE WITH THE CONNECTORS AND THEY ALL REPORTED BLOOD BACKING UP IN THE TUBING AND STRUGGLING TO KEEP IT TIGHT. THEY HAVE NOTICED THAT THEY ARE HAVING MORE DIFFICULTY IN THE LAST 2 MONTHS. I DON'T KNOW IF ANY OTHER DEPARTMENTS ARE HAVING THE SAME ISSUES WITH THESE CONNECTORS. I DON'T KNOW IF THIS COULD BE LINKED TO A LOT # SO I TOOK A PICTURE OF THE FRONT AND BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21870320 ↗
• MalfunctionJul 29, 2024Leak/Splash; Leak/Splash

  MATERIAL: MZ5309 BATCH#: UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT IV KIT INCLUDES 7IN STANDARD BORE EXTENSION SET 5 OR 6 TIMES HAS BEEN LEAKING. VERBATIM: IV KIT INCLUDES 7IN STANDARD BORE EXTENSION SET 5 OR 6 TIMES HAS BEEN LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19852180 ↗
• MalfunctionJul 17, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19762214 ↗
• MalfunctionMay 1, 2024

  IV TEAM MEMBER INSERTING IV IN PATIENT. WHEN PREPARING THE FLUSH AND CONNECTING THE EXTENSION FLUSH SET (BD MAXZERO) TO THE IV HUB, THE TUBING CAME OUT OF THE MALE END OF THE EXTENSION FLUSH SET (THAT CONNECTS DIRECTLY TO THE IV SITE) - THIS IS THE SECOND TIME THIS HAS HAPPENED TO THIS IV NURSE. BOTH OCCASIONS WERE THE SAME LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220513 ↗
• MalfunctionMar 25, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  MATERIAL # MZ5309 LOT # 23059004 IT WAS REPORTED BY CUSTOMER THAT J LOOP MALFUNCTIONED. IT WAS POURING OUT NORMAL SALINE AS NURSE WAS PUSHING IT. CONNECTIONS WERE CHECKED AND THEY WERE TIGHTENED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. J LOOP MALFUNCTIONED. IT WAS POURING OUT NORMAL SALINE AS NURSE WAS PUSHING IT. CONNECTIONS WERE CHECKED AND THEY WERE TIGHTENED. NO HARM CAME TO PATIENT. PRODUCT#: MZ5309 LOT#: 23059004

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18969400 ↗
• MalfunctionFeb 29, 2024

  J LOOP MALFUNCTIONED. IT WAS POURING OUT NORMAL SALINE AS NURSE WAS PUSHING IT. CONNECTIONS WERE CHECKED AND THEY WERE TIGHTENED. NO HARM CAME TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18807063 ↗