MaxZero MZ9271Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10885403240744), received between Jul 17, 2018 and Oct 21, 2025 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 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: IT WAS REPORTED BY CUSTOMER THAT IT WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23349372 ↗
• MalfunctionOct 15, 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 CUSTOMER THAT THEY HAVE ANOTHER LEAKING FILTER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23286566 ↗
• MalfunctionOct 15, 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: IT WAS REPORTED BY CUSTOMER THAT THEY HAVE ANOTHER LEAKING FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23286307 ↗
• MalfunctionOct 15, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TPN NOTED TO BE LEAKING AT DISTAL END OF FILTER ON THE "MICROBORE BI-FUSE EXTENSION SET, 2 IV CONNECTORS, FILTER" PIECE. QUANTITY AFFECTED: 1 EA. WAS THERE INJURY? NO - RESULTED IN THE NEED FOR INCREASED MONITORING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285363 ↗
• MalfunctionApr 23, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM I WANTED TO MAKE YOU AWARE OF A DEFECTIVE IV FILTER. LAST NIGHT, DURING AN ADMISSION, A BABIES BLOOD SUGAR CONTINUED TO DECREASE DESPITE INCREASING THE IV FLUID RATE AND CHANGING THE TYPE OF IV FLUIDS. EVENTUALLY THE BABIES BLOOD SUGAR WAS SO LOW IT WAS UNREADABLE AND THE BABY NEEDED TO HAVE AN UMBILICAL LINE PLACED TO HELPFULLY HELP INCREASE THE BLOOD SUGAR. STAFF EVENTUALLY DISCOVERED THAT THE PART OF THE IV FILTER WAS CRACKED, CAUSING THE IV FLUIDS TO LEAK SO THE BABY WASN¿T RECEIVING THE IV FLUIDS. THERE WAS ALSO ANOTHER INCIDENT THAT HAPPENED ON MONDAY NIGHT THAT I WAS JUST MADE AWARE OF AND THERE WAS A CONCERN ABOUT THE INTEGRITY OF THE IV FILTER. MICROBORE EXTENSION SET MZ9271.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891288 ↗
• MalfunctionApr 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. I WANTED TO MAKE YOU AWARE OF A DEFECTIVE IV FILTER. LAST NIGHT, DURING AN ADMISSION, A BABIES BLOOD SUGAR CONTINUED TO DECREASE DESPITE INCREASING THE IV FLUID RATE AND CHANGING THE TYPE OF IV FLUIDS. EVENTUALLY THE BABIES BLOOD SUGAR WAS SO LOW IT WAS UNREADABLE AND THE BABY NEEDED TO HAVE AN UMBILICAL LINE PLACED TO HELPFULLY HELP INCREASE THE BLOOD SUGAR. STAFF EVENTUALLY DISCOVERED THAT THE PART OF THE IV FILTER WAS CRACKED, CAUSING THE IV FLUIDS TO LEAK SO THE BABY WASN¿T RECEIVING THE IV FLUIDS. THERE WAS ALSO ANOTHER INCIDENT THAT HAPPENED ON MONDAY NIGHT THAT I WAS JUST MADE AWARE OF AND THERE WAS A CONCERN ABOUT THE INTEGRITY OF THE IV FILTER.

  Patient problems: Hypoglycemia

  MAUDE report 21891285 ↗
• MalfunctionAug 9, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR HAD LEAKING NEAR THE FILTER OF THE BIFUSE. THE FOLLOWING INFORMATION WAS PROVIDED BY INITIAL REPORTER HERE IS THE VERBATIM: LEAKING NEAR FILTER ON BIFUSE.

  Patient problems: Insufficient Information

  MAUDE report 17494953 ↗
• MalfunctionOct 29, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE PATIENT'S BEDDING WAS WET AND DURING ASSESSMENT, A FLUID LEAK FROM THE FILTER WAS FOUND. A NEW FILTER WAS OBTAINED AND CONNECTED BACK TO THE IV FLUIDS AND THE PATIENT. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8015390 ↗
• MalfunctionOct 29, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE PATIENT'S BEDDING WAS WET AND DURING ASSESSMENT, A FLUID LEAK FROM THE FILTER WAS FOUND. A NEW FILTER WAS OBTAINED AND CONNECTED BACK TO THE IV FLUIDS AND THE PATIENT. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8015117 ↗
• InjuryAug 9, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT DURING A FENTANYL INFUSION, THE PATIENT WAS MOVING HIS ARMS AND LEGS CONSTANTLY, HAD A HR IN THE 180S AND HIS RIGHT LEG HAD OCCASIONAL TREMORS. THE PATIENT RECEIVED FIVE UNSPECIFIED PRN MEDICATIONS THROUGH THE NIGHT. IN THE MORNING, THE INFUSION WAS ASSESSED AND FLUID WAS FOUND LEAKING FROM THE BIFUSE AND FILTER OF THE FENTANYL INFUSION. THE TUBING WAS REPLACED. THERE WAS NO REPORT OF LONG TERM PATIENT HARM.

  Patient problems: Inadequate Pain Relief

  MAUDE report 7768329 ↗
• MalfunctionAug 3, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED FLUID LEAKED AT UAC JUNCTION. THE UAC WAS DISCONTINUED. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7748787 ↗
• MalfunctionAug 2, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT FLUID LEAKED FROM ABOVE THE LUER LOCK ON BI-FUSE SET. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7745442 ↗
• MalfunctionAug 2, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED FLUID LEAKED ONTO THE PATIENT'S BED FROM THE SMARTSITE OF THE FILTER PORTION OF THE IV SET. NO CRACKS WERE DETECTED ON THE SET. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7742883 ↗
• MalfunctionJul 30, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT A PATIENT HAD A RIGHT LEG DOUBLE LUMEN PICC WITH TPN, LIPIDS AND PROSTIN INFUSING. DURING PATIENT ASSESSMENT, A WET SPOT WAS FOUND ON THE PATIENT¿S LINEN, THE CAP END OF THE FILTER WAS FOUND WET FROM LEAKAGE OF TPN. A NEW FILTER PRIMED WITH PATIENT IVF AND RECONNECTED TO PATIENT PICC. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7731846 ↗
• MalfunctionJul 30, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THE PUMP MODULE ALARMED FOR HIGH PRESSURE DURING AN EPINEPHRINE DRIP. THE PATIENT¿S BLOOD PRESSURE WAS VERY LABILE AND A SECOND TUBING AND PUMP MODULE WERE PREPARED TO REPLACE THE INFUSION THAT ALARMED. WHEN CHANGING THE EPINEPHRINE LINE, THE CONNECTION OF THE SET TO THE PICC WAS WET FROM A FLUID LEAK; THEREFORE, THE NEW EPINEPHRINE INFUSION WAS CONNECTED TO ANOTHER PORT ON THE PICC. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7731784 ↗
• MalfunctionJul 27, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE PATIENT'S BEDDING WAS WET AND DURING ASSESSMENT, A FLUID LEAK FROM THE FILTER WAS FOUND. A NEW FILTER WAS OBTAINED AND CONNECTED BACK TO THE IV FLUIDS AND THE PATIENT. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7729189 ↗
• MalfunctionJul 17, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE SET WAS RECEIVED AS AN UNEXPECTED PRODUCT RETURNED. A NOTE ATTACHED TO THE RETURNED PRODUCT STATES "LEAKING NEAR FILTER." BLOOD WAS SEEN IN THE FLUID PATH. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7696574 ↗