MaxZero MZXT5307Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885403471155), received between Aug 8, 2023 and Aug 18, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET WAS DISCONNECTING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER ABOUT THE J LOOP CONNECTION DISCONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22836259 ↗
• MalfunctionAug 7, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET WAS DISCONNECTING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE J LOOP CONNECTION DISCONNECTS AND ALLOWS THE PATIENT TO BLEED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22743033 ↗
• MalfunctionJun 23, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET WAS KINKED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE COUPLE OF OUR NURSES HAVE EXPRESSED CONCERNS ABOUT THE NEW T-CONNECTOR WE HAVE ON A PATIENT WITH A PICC. IT SEEMS TO BE VERY FLEXIBLE AND GETS TWISTED UP/KINKED VERY EASILY AND IN THIS CASE, WAS CAUSING AN OCCLUSION AND INABILITY TO INFUSE A MEDICATION FLUSH AND HAD 2 T-CONNECTORS BREAK WHERE THE T-CONNECTOR ATTACHES TO THE FLUIDS AND NOT THE END WHERE IT MEETS THE PORT TUBING. ADDITIONALLY, THERE ARE ISSUES AROUND THE LIPIDS AND BLOOD GETTING IN THE SMALL RESERVOIR OF THE T- CONNECTOR WHERE LABS ARE SUPPOSED TO BE OBTAINED FROM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22312665 ↗
• MalfunctionJun 23, 2025Complete Blockage; Leak/Splash; Complete Blockage; Leak/Splash

  IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET WAS KINKED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT THE COUPLE OF OUR NURSES HAVE EXPRESSED CONCERNS ABOUT THE NEW T-CONNECTOR WE HAVE ON A PATIENT WITH A PICC. IT SEEMS TO BE VERY FLEXIBLE AND GETS TWISTED UP/KINKED VERY EASILY AND IN THIS CASE, WAS CAUSING AN OCCLUSION AND INABILITY TO INFUSE A MEDICATION FLUSH AND HAD 2 T-CONNECTORS BREAK WHERE THE T-CONNECTOR ATTACHES TO THE FLUIDS AND NOT THE END WHERE IT MEETS THE PORT TUBING. ADDITIONALLY, THERE ARE ISSUES AROUND THE LIPIDS AND BLOOD GETTING IN THE SMALL RESERVOIR OF THE T- CONNECTOR WHERE LABS ARE SUPPOSED TO BE OBTAINED FROM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22312664 ↗
• MalfunctionJun 23, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE SPIN COLLAR IS VERY STIFF AND DOES NOT SPIN FREELY. THIS CONNECTOR DOES NOT SECURELY FIT THE BARD MINILOC REF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22312548 ↗
• MalfunctionJun 23, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE SPIN COLLAR IS VERY STIFF AND DOES NOT SPIN FREELY. THIS CONNECTOR DOES NOT SECURELY FIT THE BARD MINILOC REF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22312547 ↗
• MalfunctionJun 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THE SPIN COLLAR IS VERY STIFF AND DOES NOT SPIN FREELY. THE CONNECTOR DOES NOT SECURELY FIT THE MINILOC. STAFF REPORT IT "POPPING OFF" AND THEN BLEEDING VIA THE CATHETER ON TO BED LINES. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES ALL THREE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22243514 ↗
• MalfunctionJul 8, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT BD BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS SEPARATING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT THE CLEAR END THAT SPINS TO CONNECT THE PORT TO THE CATHETER IS COMING COMPLETELY OFF OF THE DEVICE. SO THE REST OF THE T-PORT CANNOT STAY ATTACHED TO THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697666 ↗
• MalfunctionJun 26, 2024Material Separation; Material Separation

  NO ADDITIONAL INFO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19615061 ↗
• MalfunctionFeb 9, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: CUSTOMER SHARED THAT THE EXTENSION SET AT THE T-PORT CONNECTION WAS LEAKING BLOOD DURING ASPIRATING. OR IT WOULD LEAK SALINE. CUSTOMER SAID THIS HAS HAPPENED ON 8 EXTENSION SETS OPENED BY NURSES IN THE ED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18674929 ↗
• MalfunctionAug 8, 2023Defective Component; Defective Component

  IT WAS REPORTED WHILE USING BD MAXZERO MINIBORE PRESSURE RATED EXTENSION SET, REMOVABLE IV CONNECTOR THERE WAS COMPONENT SEPARATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INFUSION RN STATE THAT THE PRODUCT IS DEFECTIVE. HE STATES THAT THE SPIN COLLAR IS ABLE TO BE REMOVED WHEREAS THE OLD SMARTSITE PRODUCT (20043E) YOU COULD NOT REMOVE. ¿T-PORT FELL APART WHEN HOOKING TO IV CATHETER. HUB CAME APART FROM LUER LOCK.¿ ON THE SI EVENT.

  Patient problems: Insufficient Information

  MAUDE report 17483781 ↗