MaxZero MZ9279Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10885403230622), received between Oct 21, 2020 and Apr 17, 2026 — classified as 2 injuries, 10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Complete Blockage

  IT IS REPORTED, MAXZERO, NO FLOW OCCURS. DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910373 ↗
• MalfunctionDec 1, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS WEEK WE RECEIVED A COMPLAINT FROM A CUSTOMER OF US WHO USES THE ARTICLE MZ9279 IN COMBINATION WITH THE PCA00001. LOT: 25029193. STILL HAVE 5 BOXES OF THIS LOT NUMBER, BUT NOW THEY HAVE PROBLEMS WITH THE CONNECTION OF THE MAX ZERO. WHERE THERE IS A DEFECT. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: PLEASE CONFIRM THE NUMBER OF PRODUCTS AFFECTED (DISPLAYED THE DEFECT)? A HOLE BOX UNUSED AND 7 BOXES OF THE SAME LOT. PLEASE CONFIRM HOW THE FAULT WAS IDENTIFIED? A NURSE WANTED TO START A SEDATION / THIS A FEW TIMES. PLEASE CONFIRM WHEN THE FAULT WAS IDENTIFIED DURING PRIMING OR DURING INFUSION? IF DURING INFUSION, HOW LONG INTO THE INFUSION? START INFUSION. PLEASE CONFIRM THE INFUSION SET-UP ¿ GRAVITY OR PUMP, HEIGHT OF INFUSION LINE, ENTRY POINT TO PATIENT, INFUSION RATE AND PRESSURE, INFUSION LINE SET-UP (OTHER EXTENSIONS OR ACCESSORIES) ETC? USED WITH THE SET PCA 00001 OPERATION SET UP. PLEASE CONFIRM IF THERE IS ANY VISIBLE DAMAGE ON THE SET ¿ SUCH AS CRACKS, FLASHES OR DEFORMATION OF THE PISTON?

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687360 ↗
• MalfunctionNov 6, 2025Nonstandard Device; Defective Device; Nonstandard Device; Defective Device

  IT WAS REPORTED THAT BD MAXZERO EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT THE FIRST ONE - UNABLE TO DISENGAGE MAX ZERO FROM TUBING. THE SECOND ONE- WHILE TAKING SET OUT OF PACKAGING, ONE OF THE TUBING AT BIFURCATION FELL OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23492586 ↗
• MalfunctionJul 25, 2025Crack; Material Separation; Crack; Material Separation

  IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EXTENSION SET LUER PIN HAS BECOME STUCK IN THE MAX ZERO BUNG. LUER LOCK COLLAR HAS COME LOOSE ON EXTENSION SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22615707 ↗
• MalfunctionJul 25, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS DIFFICULT TO DISCONNECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EXTENSION SET LUER PIN HAS BECOME STUCK IN THE MAX ZERO BUNG. LUER LOCK COLLAR HAS COME LOOSE ON EXTENSION SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22614710 ↗
• MalfunctionJul 11, 2025Material Separation; Material Separation

  NO ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 22482501 ↗
• MalfunctionJul 11, 2025Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22480303 ↗
• MalfunctionApr 2, 2024Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR HAD A VALVE MALFUNCTION. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: PT HAS A PREMICATH 28G 1 LUMEN PICC WITH 2 X 2WAY EXTENSION SETS WITH BACK CHECK VALVES ATTACHED. THE SECOND 2-WAY EXTENSION SET WITH BACK CHECK VALVES HAD A LIPID MEDICATION (WHITE IN COLOUR) RUNNING THROUGH 1 LUMEN AND THE OTHER LUMEN WAS IDLE AT THE TIME WITH NOTHING ATTACHED TO THE MZ1000 BUNG AND UNCLAMPED (INTERMITTENT MEDICATIONS BEING GIVEN BUT NOT AT THE TIME OF EVENT). THE LIPID WAS NOTED TO BE BACKTRACKING UP THE IDLE LINE AND PAST THE BACK CHECK VALVE. I'VE ATTACHED A PHOTO. CONFIRMED WITH THE CLINICIAN THAT THE LIPID HAD NEVER BEEN ATTACHED TO THE OTHER LUMEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19028609 ↗
• MalfunctionFeb 8, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR LEAKED FROM THE VALVE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "LEAK AT THE VALVE LEVEL DESPITE WELL CONNECTED TUBING AND DESPITE CHANGED TUBING (IT'S THE VALVE WHERE THE PARENTERAL NUTRITION PASSED)".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16328021 ↗
• InjuryDec 16, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A MINIBORE BI-FUSE EXT, 2 IV CNNTR, 2CKV EXPERIENCED COMPONENT SEPARATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "THE DEVICE IS NOT PROPERLY WELDED IN ALL ITS CONNECTING PARTS. SPECIFICALLY, THE SET THAT CONNECTS TO THE CVC, IN THE PART OF THE CONJUNCTION OF THE TWO BRANCHES OF THE OCTOPUS, ALSO DETACHES WITH NOT NECESSARILY VIOLENT STRESSES. UNFORTUNATELY THIS HAPPENED TO A LITTLE PATIENT OF OURS DURING AN INFUSION. SINCE THIS IS AN EVENT THAT CANNOT AND MUST ABSOLUTELY NOT HAPPEN AS IT EXPOSES YOU TO THE RISK OF EVEN SUBSTANTIAL BLEEDING (WHICH IS WHAT HAPPENED IN PART), OF POSSIBLE INFECTION AND LEAKAGE OF ANTIBLASTICS, I CONSIDER IT APPROPRIATE TO REPORT IT IMMEDIATELY."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11023517 ↗
• MalfunctionDec 5, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT MINIBORE BI-FUSE EXT, 2 IV CNNTR, 2CKV WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONNECTION OF THE 2-WAY CONNECTOR CONNECTED TO THE PICC LINE BROKE WHEN UNSCREWING IT FOR ITS WEEKLY CHANGE. IMPOSSIBLE TO REMOVE UNDER STERILE CARE (STERILE CARE). USE OF NON-STERILE CLAMPS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10954093 ↗
• InjuryOct 21, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT MINIBORE BI-FUSE EXT, 2 IV CNNTR, 2CKV WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BREAKAGE OF THE END OF A 2-WAY CONNECTOR IN THE LIGHT OF THE KT PICCLINE THEREFORE NOW UNUSABLE.

  Patient problems: No Information

  MAUDE report 10710184 ↗