MaxZero MZ5302Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10885403230554), received between Aug 22, 2019 and Sep 25, 2026 — classified as 57 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (17 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 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Complete Blockage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905595 ↗
• MalfunctionSep 23, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873027 ↗
• MalfunctionSep 22, 2026Disconnection; Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859134 ↗
• MalfunctionSep 22, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859131 ↗
• MalfunctionAug 25, 2026Connection Problem

  Patient problems: Hemolysis

  MAUDE report 50434967 ↗
• MalfunctionJun 17, 2026Crack

  IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS CRACKED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED THAT TWO OF THE MAXZERO WERE CRACKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25541614 ↗
• MalfunctionJun 3, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD MAXZERO MINIBORE PRESSURE RATED EXTENSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING FROM CONNECTIONS OF EXTENSIONS FROM BROVIAC LINE DESPITE TIGHTENING OF CONNECTIONS. INJURIES OR ADVERSE EVENT: NO. ITEM: MZ5302. QUANTITY AFFECTED: 1EA. SERIAL/LOT NUMBER: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25383654 ↗
• MalfunctionMay 22, 2026Fitting Problem

  IT WAS REPORTED THAT THE BD MAXZERO MINIBORE PRESSURE RATED EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE COME ACROSS SOME DEFECTIVE J LOOPS THAT EITHER DONT FLUSH DONT THREAD OR LEAK. I HAVE THE LOT NUMBER BD MAXZERO LOT 26025473. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENTS IN FORMAT DD-MMM-YYYY? (B)(6) 2026, (B)(6) 2026, MULTIPLE OTHERS AT EACH OF MY SITES BUT I DON'T HAVE EXACT DATES TOTAL NUMBER OF OCCURRENCES OF EACH EVENT? 1 DID THE ISSUE HAPPEN DURING PATIENT USE? IF YES, WAS THERE ANY INJURY? IF SO, PLEASE DESCRIBE AND INCLUDE ANY MEDICAL TREATMENT NEEDED AS A RESULT? (B)(6) 2026- CAP CAME OFF OF J LOOP AND PATIENT HAD BLOOD LOSS. DID NOT REQUIRE MEDICAL TREATMENT. (B)(6) 2026- PRIOR TO PATIENT CARE, J LOOP WOULD NOT FLUSH. I HAVE THIS J LOOP IF YOU WOULD LIKE IT. OTHER INSTANCES REPORT LEAKING FROM THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25263188 ↗
• MalfunctionMay 22, 2026Obstruction of Flow

  IT WAS REPORTED THAT THE BD MAXZERO MINIBORE PRESSURE RATED EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE COME ACROSS SOME DEFECTIVE J LOOPS THAT EITHER DONT FLUSH DONT THREAD OR LEAK. I HAVE THE LOT NUMBER BD MAXZERO LOT 26025473 ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENTS IN FORMAT DD-MMM-YYYY? (B)(6) 2026, (B)(6) 2026, MULTIPLE OTHERS AT EACH OF MY SITES BUT I DON'T HAVE EXACT DATES TOTAL NUMBER OF OCCURRENCES OF EACH EVENT? 1 DID THE ISSUE HAPPEN DURING PATIENT USE? IF YES, WAS THERE ANY INJURY? IF SO, PLEASE DESCRIBE AND INCLUDE ANY MEDICAL TREATMENT NEEDED AS A RESULT? (B)(6) 2026- CAP CAME OFF OF J LOOP AND PATIENT HAD BLOOD LOSS. DID NOT REQUIRE MEDICAL TREATMENT. (B)(6) 2026- PRIOR TO PATIENT CARE, J LOOP WOULD NOT FLUSH. I HAVE THIS J LOOP IF YOU WOULD LIKE IT. OTHER INSTANCES REPORT LEAKING FROM THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25263186 ↗
• MalfunctionApr 30, 2026Leak/Splash

  IT WAS REPORTED THAT THE BD MAXZERO MINIBORE PRESSURE RATED EXTENSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25053277 ↗
• MalfunctionApr 22, 2026Complete Blockage

  IT IS REPORTED, OCCLUSION WITH MAXPLUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24956302 ↗
• MalfunctionApr 22, 2026Failure to Disconnect

  IT IS REPORTED, CONNECTIONS ARE VERY DIFFICULT TO GET OFF TO THE POINT IT HAS CAUSED PROVIDERS TO REPLACE LINES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24956291 ↗
• MalfunctionApr 20, 2026Crack; Fluid/Blood Leak; Leak/Splash

  IT IS REPORTED, MINIBORE PRESSURE, REMOVABLE IV CNNCTR, EXTENSION SET CRACKED AND LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24930501 ↗
• MalfunctionFeb 13, 2026Disconnection; Leak/Splash

  THE BLUE CAP WHICH COMES PRE ATTACHED TO THE PIGTAIL CAME UNDONE DURING A CASE TODAY. MEDICATIONS GIVEN WITHOUT CHANGES IN LAB- DRAPES LIFTED AND THE LINE WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332356 ↗
• MalfunctionJan 22, 2026Leak/Splash

  IT IS REPORTED LEAK. VERBATIM: RN CARING FOR PATIENT NOTED THAT THE PATIENT'S LINEN WAS SATURATED WITH TPN. UPON INSPECTION OF PICC LINE, NOTICED THAT THE JLOOP HAD FLUID LEAKING AT THE CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24149785 ↗
• MalfunctionDec 8, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET WAS LOOSE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT DOES NOT TIGHTEN AT THE END OF THE EXTENSION TUBING AND/OR BECOMES LOOSE DURING IV MED ADMIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741816 ↗
• MalfunctionNov 21, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE LUER LOCK CONNECTIONS ON BOTH ENDS SEEM TO BE LOOSE. EVEN WHEN THE TUBING IS FULLY SCREWED TO THE HUB, AIR SEEMS TO LEAK IN, AND WE HAVE HAD A COUPLE OF INSTANCES WHERE THE BLUE NEEDLELESS CONNECTOR ON THE OTHER END OF THE TUBING HAS UNSCREWED AND FALLEN OFF ON ITS OWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23623690 ↗
• MalfunctionNov 21, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  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 THE LUER LOCK CONNECTIONS ON BOTH ENDS SEEM TO BE LOOSE. EVEN WHEN THE TUBING IS FULLY SCREWED TO THE HUB, AIR SEEMS TO LEAK IN, AND WE HAVE HAD A COUPLE OF INSTANCES WHERE THE BLUE NEEDLELESS CONNECTOR ON THE OTHER END OF THE TUBING HAS UNSCREWED AND FALLEN OFF ON ITS OWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23623689 ↗
• MalfunctionSep 18, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT THE NEW IV EXTENSION SET WAS USED WHEN THE SYRINGE FULL OF BLOOD WAS REMOVED THE CLAVE HAD A DROP OF BLOOD ON IT THAT HAD TO BE WIPED OFF PRIOR TO BEING RE-ACCESSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084106 ↗
• MalfunctionSep 16, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD MAXZERO EXTENSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTED WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT BLOOD STAYING IN MICROCLAVE EVEN AFTER PULSATING SALINE FLUSHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23069157 ↗
• MalfunctionSep 16, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD PRESSURE RATED EXTENSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT WHEN DRAWING FROM A CHILD THAT WAS A DIFFICULT STICK BLOOD WAS GETTING STUCK IN THE MICRO CLAVE. AS A RESULT, FROM THAT THE SPECIMEN WAS HEMOLYZED. THIS RN THEN HAD TO USE A DIFFERENT METHOD WHEN DRAWING BLOOD AND REQUIRING ANOTHER POKE FOR THE CHILD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23069087 ↗
• MalfunctionSep 14, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT BD MAXZERO EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT NEW IV PLACED AND LABS DRAWN WITH IV START. WHEN THE SYRINGE WAS REMOVED FROM THE MAXZERO THERE WAS A DROP OF BLOOD AT THE END OF THE CONNECTION THAT HAD TO BE WIPED OFF PRIOR TO RE-ACCESSING. A FEW MINUTES AFTER LEAVING THE ROOM THE FAMILY CALLED OUT AND TOLD ME THAT THE MAXZERO HAD COME DISCONNECTED. THERE WAS BLOOD THAT HAD DRIPPED ONTO THE FLOOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23047851 ↗
• MalfunctionSep 14, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT NEW IV PLACED AND LABS DRAWN WITH IV START. WHEN THE SYRINGE WAS REMOVED FROM THE MAXZERO THERE WAS A DROP OF BLOOD AT THE END OF THE CONNECTION THAT HAD TO BE WIPED OFF PRIOR TO RE-ACCESSING. A FEW MINUTES AFTER LEAVING THE ROOM THE FAMILY CALLED OUT AND TOLD ME THAT THE MAXZERO HAD COME DISCONNECTED. THERE WAS BLOOD THAT HAD DRIPPED ONTO THE FLOOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23047849 ↗
• MalfunctionAug 21, 2025Disconnection

  NEW IV PLACED AND LABS DRAWN WITH IV START. WHEN THE SYRINGE WAS REMOVED FROM THE MAXZERO THERE WAS A DROP OF BLOOD AT THE END OF THE CONNECTION THAT HAD TO BE WIPED OFF PRIOR TO RE-ACCESSING. A FEW MINUTES AFTER LEAVING THE ROOM THE FAMILY CALLED OUT AND TOLD ME THAT THE MAXZERO HAD COME DISCONNECTED. THERE WAS BLOOD THAT HAD DRIPPED ONTO THE FLOOR. MANUFACTURER RESPONSE FOR SET, ADMINISTRATION, INTRAVASCULAR, MAXZERO (PER SITE REPORTER). SUGGESTED ADDITIONAL STAFF EDUCATION. BD HAS SENT REPS MULTIPLE TIMES FOR EDUCATION. ISSUES CONTINUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22860971 ↗
• MalfunctionAug 21, 2025Leak/Splash

  NEW IV PLACED ON PT AND LABS DRAWN DURING IV START. THE NEW IV EXTENSION SET WAS USED WHEN THE SYRINGE FULL OF BLOOD WAS REMOVED THE CLAVE HAD A DROP OF BLOOD ON IT THAT HAD TO BE WIPED OFF PRIOR TO BEING RE-ACCESSED. MANUFACTURER RESPONSE FOR SET, ADMINISTRATION, INTRAVASCULAR, MAXZERO (PER SITE REPORTER). MANUFACTURER SUGGESTED MORE STAFF EDUCATION. EDUCATION PROVIDED. ISSUES CONTINUE. BLOOD COMING OUT OF THE END OF THE MAXZERO PUTS STAFF AT A RISK FOR EXPOSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860756 ↗