MaxZero MZ5305Recalls & reported problems
BD Switzerland Sàrl · Pressure rated extension set, IV connector, no clamp, 18 cm (7.0 in) · Class 2
All models of MaxZero (47)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10885403230585), received between Jul 13, 2021 and Apr 8, 2026 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Improper Flow or Infusion” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Improper Flow or Infusion4
- Detachment of Device or Device Component2
- Leak/Splash2
- Complete Blockage1
- Contamination1
- Device Contamination with Chemical or Other Material1
- Fluid/Blood Leak1
- Infusion or Flow Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Insufficient Information4
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 8, 2026Fluid/Blood Leak
IT WAS REPORTED, IV/J-LOOP WAS LEAKING BLOOD BACK FROM THE THREAD PORTION. IT WAS ALMOST AS IF THE PLASTIC THREAD WAS NOT PROPERLY ADHERED TO THE PLIABLE TUBING PORTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24817968 ↗MalfunctionDec 15, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23803660 ↗MalfunctionDec 15, 2025Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23803659 ↗MalfunctionMar 17, 2025Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR(S) HAD BLOOD BACKFLOW FROM THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WE HAVE RECEIVED FOUR OTHER MEDICAL DEVICE VIGILANCE REPORTS REGARDING MAXZERO VALVES WITH EXTENSION (REF: MZ5305, LOT: 24099033). ONE OTHER CASE IN A PEDIATRIC HOSPITAL, ONE CASE IN A GENERAL WARD, AND TWO CASES IN ORTHOPEDICS. FOR THE PEDIATRIC CASE, THE GERIATRIC CASE, AND ONE OF THE ORTHOPEDICS CASES, THE LEAK AT THE VALVE WAS IDENTIFIED WHEN THE TUBING WAS CONNECTED TO THE CATHETER. INDEED, REFLUX WAS OBSERVED UP TO THE VALVE. PULSED RINSING WAS PERFORMED, AND NO REFLUX WAS SUBSEQUENTLY OBSERVED. FOR THE SECOND ORTHOPEDICS CASE, THE REFLUX WAS OBSERVED WHEN AN IV ANALGESIC WAS CONNECTED TO THE DEVICE.
Patient problems: Insufficient Information
MAUDE report 21626154 ↗MalfunctionMar 17, 2025Improper Flow or Infusion; Improper Flow or Infusion
MalfunctionMar 17, 2025Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR(S) HAD BLOOD BACKFLOW FROM THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WE HAVE RECEIVED FOUR OTHER MEDICAL DEVICE VIGILANCE REPORTS REGARDING MAXZERO VALVES WITH EXTENSION (REF: MZ5305, LOT: 24099033). ONE OTHER CASE IN A PEDIATRIC HOSPITAL, ONE CASE IN A GENERAL WARD, AND TWO CASES IN ORTHOPEDICS. FOR THE PEDIATRIC CASE, THE GERIATRIC CASE, AND ONE OF THE ORTHOPEDICS CASES, THE LEAK AT THE VALVE WAS IDENTIFIED WHEN THE TUBING WAS CONNECTED TO THE CATHETER. INDEED, REFLUX WAS OBSERVED UP TO THE VALVE. PULSED RINSING WAS PERFORMED, AND NO REFLUX WAS SUBSEQUENTLY OBSERVED. FOR THE SECOND ORTHOPEDICS CASE, THE REFLUX WAS OBSERVED WHEN AN IV ANALGESIC WAS CONNECTED TO THE DEVICE.
Patient problems: Insufficient Information
MAUDE report 21626144 ↗MalfunctionMar 17, 2025Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR(S) HAD BLOOD BACKFLOW FROM THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: WE HAVE RECEIVED FOUR OTHER MEDICAL DEVICE VIGILANCE REPORTS REGARDING MAXZERO VALVES WITH EXTENSION (REF: MZ5305, LOT: 24099033). ONE OTHER CASE IN A PEDIATRIC HOSPITAL, ONE CASE IN A GENERAL WARD, AND TWO CASES IN ORTHOPEDICS. FOR THE PEDIATRIC CASE, THE GERIATRIC CASE, AND ONE OF THE ORTHOPEDICS CASES, THE LEAK AT THE VALVE WAS IDENTIFIED WHEN THE TUBING WAS CONNECTED TO THE CATHETER. INDEED, REFLUX WAS OBSERVED UP TO THE VALVE. PULSED RINSING WAS PERFORMED, AND NO REFLUX WAS SUBSEQUENTLY OBSERVED. FOR THE SECOND ORTHOPEDICS CASE, THE REFLUX WAS OBSERVED WHEN AN IV ANALGESIC WAS CONNECTED TO THE DEVICE.
Patient problems: Insufficient Information
MAUDE report 21625822 ↗MalfunctionAug 9, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED THAT ON 2 OCCASIONS THE BD MAXZERO¿ 1-WAY PRESSURE RATED EXTENSION SET THAT THE NURSE WAS UNABLE TO PURGE THE DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: ON 2 OCCASIONS, WHEN ABOUT TEN DEVICES WERE IN USE, THE NURSE FOUND IT IMPOSSIBLE TO PURGE THE DEVICES. SHE WAS FORCED TO CHANGE THE DEVICE AND USE ANOTHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17492754 ↗MalfunctionMay 25, 2023Contamination; Contamination
IT WAS REPORTED THAT THE BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR(S) EXPERIENCED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: YELLOW TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17008294 ↗MalfunctionOct 31, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE BD MAXZERO¿ EXTENSION SET DETACHED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE IV CONNECTION PORTION OF THE EXTENSION SET WAS NOT SECURE. WHEN ATTEMPTING TO SECURE TO IV HUB, THE ENTIRE CONNECTION PORTION DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15700962 ↗MalfunctionSep 19, 2022Detachment of Device or Device Component; Protective Measures Problem
THE IV CONNECTION PORTION OF THE EXTENSION SET WAS NOT SECURE. WHEN ATTEMPTING TO SECURE TO IV HUB, THE ENTIRE CONNECTION PORTION DETACHED. FDA SAFETY REPORT ID #(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15455993 ↗MalfunctionMay 18, 2022Material Discolored; Material Discolored
IT WAS REPORTED THAT 5 BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR(S) EXPERIENCED FOREIGN MATTER IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRIOR TO USE THE CUSTOMER OBSERVED BROWNISH DISCOLORATION TO THE TUBING. THE TUBING IS STILL TRANSPARENT BUT HAS A BROWNISH TINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14431675 ↗MalfunctionAug 26, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE PRESSURE RATED EXT, IV CONNECTOR, NO CL EXTENSION TUBING SEPARATED FROM THE IV CATHETER HUB DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEW IV EXTENSION TUBING HUB BACKED OFF IV CATHETER HUB."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12375583 ↗MalfunctionJul 13, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A PRESSURE RATED EXT, IV CONNECTOR, NO CL HAD FOREIGN MATTER. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "DURING THE PREPARATION OF THE MATERIAL FOR INFUSION OF A PATIENT, WE NOTED THE YELLOWISH COLOUR OF THE EXTENSION TUBE. THIS YELLOWISH COLOUR ONLY APPEARED ON THE BATCH SERIES INDICATED ABOVE. CLINICAL CONSEQUENCES OBSERVED : MATERIAL NOT USED TO INFUSE THE PATIENT DUE TO THE UNUSUAL COLOUR OF THE EXTENSION TUBE"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12162506 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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