MaxZero MZX5305Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10885403463785), received between Mar 15, 2023 and Mar 25, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Fluid/Blood Leak; Separation Failure

  IT WAS REPORTED BY THE CUSTOMER THAT DURING IV INITIATION, THE EXTENSION SET SEPARATED INTO TWO PIECES, CAUSING FLUID LEAKAGE AT THE CATHETER SITE. ADDITIONAL INFORMATION. ADVERSE EVENT WHERE BLOOD BECAME UNCONTAINED AND ALMOST GOT ON NURSE.

  Patient problems: Exposure to Body Fluids

  MAUDE report 24687335 ↗
• MalfunctionMar 25, 2026Fluid/Blood Leak; Separation Failure

  IT WAS REPORTED BY THE CUSTOMER THAT DURING IV INITIATION, THE EXTENSION SET SEPARATED INTO TWO PIECES, CAUSING FLUID LEAKAGE AT THE CATHETER SITE. ADDITIONAL INFORMATION: ADVERSE EVENT WHERE BLOOD BECAME UNCONTAINED AND ALMOST GOT ON NURSE.

  Patient problems: Exposure to Body Fluids

  MAUDE report 24687334 ↗
• MalfunctionMar 24, 2026Fluid/Blood Leak

  IT WAS REPORTED, Y SITE STARTED LEAKING AND BLOOD BACKED UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681081 ↗
• MalfunctionJun 10, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT WHEN THE TECHNICIAN ATTEMPTED TO FLUSH THE IV WITH NS PRIOR TO CONTRAST ADMINISTRATION THE IV "LEAKED EVERYWHERE". ED PARAMEDIC WENT TO INSPECT IV AND THE CONNECTION BETWEEN THE IV CATHETER HUB AND THE EXTENSION TUBING WOULD NOT PROPERLY THREAD; THUS THE IV WAS LEAKING ANYTIME IT WAS FLUSHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22178602 ↗
• MalfunctionMay 6, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXZERO NEEDLELESS CONNECTOR WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT LEAKING AT THE CLAVE (PORT ON THE CONNECTION) ON THE IV CONNECTION TUBING RESULTING IN EXCESSIVE AMOUNT OF IV FLUID ON PT'S BED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21972951 ↗
• MalfunctionMay 20, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19356498 ↗
• MalfunctionMay 14, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: ¿CONNECTED EXTENSION TUBING TO IV CATHETER, CONNECTED TO IV FLUIDS AND THE EXTENSION TUBING CAME PART FROM ITSELF. IV FLUIDS WERE FLOWING OUT, LUCKILY NO BLOOD LEAK FROM EXTENSION PART THAT WAS STILL ATTACHED TO PT AND IV. FLUIDS DISCONNECTED AND NEW EXTENSION TUBING CONNECTED¿ 1. ARE YOU ABLE TO PROVIDE THE DATE OF EVENT IN FORMAT DD-MMM-YYYY? 18-04-2024. 2. ARE YOU ABLE TO PROVIDE THE BATCH/LOT NUMBER? UNKNOWN. 3. WAS ISSUE BEING DESCRIBED NOTED BEFORE, OR DURING USED? DURING USE. 4. WAS THERE ANY PATIENT INVOLVEMENT? YES. 5. ANY ADVERSE EVENTS OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO. 6. WHAT WAS THE PATIENT OUTCOME? N/A. 7. WAS THERE ANY DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THIS EVENT? YES, NEED TO OBTAIN NEW PRODUCTS AND SETUP. 8. WHAT PROCEDURE WAS BEING PERFORMED? ADMINISTRATION OF IV FLUIDS. 9. WHAT MEDICATION WAS USED IN THE PROCEDURE? N/A. 10. WAS THERE ANY MEDICAL INTERVENTION DUE TO THIS EVENT? NO. 11. DOES A RETURN SHIPPING LABEL NEED TO BE GENERATED? IF YES, KINDLY PROVIDE TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310921 ↗
• MalfunctionFeb 26, 2024Material Separation; Material Separation

  NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL #: MZX5305, BATCH#: 23109324. IT WAS REPORTED BY CUSTOMER THAT IV INSERTED AND ATTEMPTING LAB DRAW. UPON ATTACHING EXTENSION TUBING TO ANGIOCATH HUB AND DRAWING OF BLOOD THROUGH EXTENSION TUBING THE BLUE PRESSURE CAP CAME OFF TUBING CAUSING BLOOD TO POUR OUT OF REMAINING TUBING. PRESSURE APPLIED ABOVE IV SITE AND NURSE ASSIST BUTTON ACTIVATED. SECOND RN CAME TO BEDSIDE TO ASSIST BY GATHERING NEW SUPPLIES TO PREVENT NEEDING TO REMOVE ANGIOCATH AND START NEW IV. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INJURIES OR ADVERSE EVENT: NO. ITEM: MZX5305. QUANTITY AFFECTED: (B)(4). SERIAL/LOT NUMBER: (B)(6). PO : (B)(6). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: IV INSERTED AND ATTEMPTING LAB DRAW. UPON ATTACHING EXTENSION TUBING TO ANGIOCATH HUB AND DRAWING OF BLOOD THROUGH EXTENSION TUBING THE BLUE PRESSURE CAP CAME OFF TUBING CAUSING BLOOD TO POUR OUT OF REMAINING TUBING. PRESSURE APPLIED ABOVE IV SITE AND NURSE ASSIST BUTTON ACTIVATED. SECOND RN CAME TO BEDSIDE TO ASSIST BY GATHERING NEW SUPPLIES TO PREVENT NEEDING TO REMOVE ANGIOCATH AND START NEW IV.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18775459 ↗
• MalfunctionJan 17, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS LABELED INCORRECTLY THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: CAN YOU TELL ME THE CORRECT SIZE FOR THE FOLLOWING ITEM - ITEM ID # MZX5305 - ITEM DESCRIPTION EXT SET 8"PRATED STDR NAC-Y SCLAMP? ON THE MEDICAL MASTER CATALOG ALONG WITH THE DMLSS WEBSITE IT'S LISTED AS 8", BUT ON THE ACTUAL PACKAGING IT'S 6". PLEASE OPEN THE ABOVE ATTACHMENT FOR FURTHER DETAILS. ANY ASSISTANCE WILL BE GREATLY APPRECIATED. PLEASE CONTACT ME WITH ANY QUESTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18528857 ↗
• MalfunctionSep 29, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation

  IT WAS REPORTED THAT BD MAXZERO EXTENSION SET SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: ¿TARGET: SUPPLES WILL REMAIN INTACT AND FUNCTION AS INTENDED. ACTUAL: TWO BD MAXZERO EXTENSION SETS OF SAME LOT NUMBER DISCONNECTED FROM HUB WHERE IT SHOULD REMAIN PERMANENTLY CONNECTED. GAP: SUPPLIES WASTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17848828 ↗
• MalfunctionAug 8, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT BD MAXZERO¿ EXTENSION SET, STANDARD BORE, PRESSURE RATED, 1 BONDED MAXZERO¿ NEEDLE-FREE CONNECTOR, 1 MAX Y-SITE, 1 WHITE SLIDE CLAMP, SPIN MALE LUER LOCK TUBING SEPARATED FROM THE LOCKING COLLAR WHEN ATTACHING TO THE PATIENT RESULTING IN BLOOD BACK-UP AND IV RESTART. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV ACCESS DEVICE MALFUNCTION - STARTING A NEW PERIPHERAL IV ON PT., PLACED AND THREADED CATHETER AND RETRACTED NEEDLE, WHEN HOOKING UP EXTENSION TUBING HUB TO END OF IV CATHETER, SWIVELED ATTACHMENT FELL OFF FROM THE TUBING, LEAVING THE IV PATENT AND BACKING UP WITH BLOOD ONTO BEDDING. SINCE NO TUBING AND CLAMP TO STOP BLEEDING, IV PULLED AND RESTARTED WITH A NEW SET UP. 1. WAS THERE ANY HARM OR INJURY TO THE PATIENT, HEALTH CARE PROVIDER, OR ANY OTHER PERSON? YES ¿ ADDITIONAL NEED TO START ANOTHER LINE 2. WAS THERE A DELAY OF OR CHANGE IN THE COURSE OF TREATMENT DUE TO THE EVENT? PLEASE PROVIDE ANY AVAILABLE DETAILS. YES ¿ ADDITIONAL NEED TO START ANOTHER LINE 3. IF NOT ANSWERED IN QUESTION #2, WHAT WAS THE MEDICATION ADMINISTERED TO THE PATIENT? UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17479416 ↗
• MalfunctionJun 14, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT DURING USE WITH AN UNSPECIFIED AMOUNT OF BD MAXZERO¿ PRESSURE-RATED EXTENSION SET ANESTHESIA WOULD NOT FLOW. DEVICE SWITCHED OUT AND PATIENT HAD MULTIPLE "POKES", THERE WAS NO ADDITIONAL PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ANESTHESIA COULD NOT PUSH FLUID, THOUGHT IV WAS BAD, WANTED ANOTHER IV STARTED. I SWITCHED THE IV FLUID TUBING TO THE SECONDARY PORT AND IT FLOWED PERFECTLY. PATIENTS HAVE BEEN GETTING POKED MULTIPLE TIMES BECAUSE WE THINK THE IV IS BAD, BECAUSE IT WONT FLUSH. BUT IF WE USE THE SECONDARY PORT, FLUID FLOWS GREAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17132122 ↗
• MalfunctionMar 15, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD MAXZERO¿ EXTENSION SET EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SET IS DISCONNECTED AT JUNCTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16550448 ↗