MaxZero MZ9226Recalls & reported problems
BD Switzerland Sàrl · Microbore extension set, IV connector, filter, 152 cm (60 in) · Class 2
Quick summary
This BD MaxZero IV extension set is a thin tube with a filter used to extend an intravenous line. Of its 129 reports, 127 are malfunctions and 2 are injuries, with no deaths; many describe fluid leaking from the set, and some describe a complete blockage. Reports fell to 4 in the last 12 months from 19 in the 12 months before. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 130
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 130 adverse event reports that list this exact device (DI 10885403240621), received between Aug 31, 2018 and Sep 14, 2026 — classified as 2 injuries, 128 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (58 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash58
- Fluid/Blood Leak53
- Complete Blockage8
- Backflow5
- Insufficient Device Problem Information5
- Crack4
- Break3
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions57
- No Information34
- No Consequences Or Impact To Patient23
- No Known Impact Or Consequence To Patient9
- Insufficient Information5
- Convulsion/Seizure1
- Low Oxygen Saturation1
- No Code Available1
Recent adverse event reports
The 25 most recent of 130 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763183 ↗MalfunctionMar 30, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24731031 ↗MalfunctionDec 16, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824491 ↗MalfunctionNov 20, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD MAXZERO EXTENSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD FILTER LEAKING. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23605379 ↗MalfunctionNov 11, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT IV PUMP READING DOWNSTREAM OCCLUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23528802 ↗MalfunctionOct 23, 2025Complete Blockage; Complete Blockage
NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23372776 ↗MalfunctionOct 23, 2025Leak/Splash; Leak/Splash
NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23372775 ↗MalfunctionOct 23, 2025Leak/Splash; Leak/Splash
NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23372774 ↗MalfunctionOct 20, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD MAXZERO EXTENSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ARE HAVING ISSUES WITH OUR FILTER TUBING LEAKING AGAIN. THE LOT NUMBER IS 24089377.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23336381 ↗MalfunctionAug 19, 2025Leak/Splash; Leak/Splash
MalfunctionJul 8, 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 THE PRODUCT IS LEAKING AT THE TUBING/FILTER JUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22435167 ↗MalfunctionJul 8, 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 THE PRODUCT IS LEAKING AT THE TUBING/FILTER JUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22435159 ↗MalfunctionJul 8, 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 THE PRODUCT IS LEAKING AT THE TUBING/FILTER JUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22432759 ↗MalfunctionJun 4, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXZERO MICROBORE EXTENSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM, IT WAS REPORTED BY CUSTOMER THAT IV SYRINGE TUBING WITH FILTER CRACKED AND LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143441 ↗MalfunctionJun 2, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXZERO MICROBORE 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 LEAKING TUBING AT THE SITE OF THE FILTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22127476 ↗MalfunctionMay 27, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT BD MAXZERO MICROBORE EXTENSION SET WAS SEPARATED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY THE CUSTOMER THAT IV TUBING FOUND DISCONNECTED DISTAL TO FILTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22091214 ↗MalfunctionMay 19, 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 MEDLINE CRACKED ON MILRINONE GTT; NOTICED WHEN PLUGGING IN ANOTHER MEDICATION WHEN FLUID DRIPPED ON HAND. FOUND MILRINONE ALL OVER PUMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22049102 ↗MalfunctionApr 21, 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 IT WAS REPORTED BY CUSTOMER THAT MULTIPLE INCIDENCE OF LEAKING SYRINGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21878724 ↗MalfunctionApr 3, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IV PUMP BEEPING DOWNSTREAM OCCLUSION INTERMITTENTLY ABOUT EVERY 15 TO 20 MINUTES. CHANGED PUMPS AND CHECKED CLAMPS MULTIPLE TIMES. WHEN INSPECTING SYRINGE IT WAS STILL AT 49ML MEANING THE PATIENT HAD NOT RECEIVED THE MEDICATION IN ABOUT 2 HOURS AFTER DISCONNECTED AND CHANGING THE TUBING OUT THE ISSUE WAS RESOLVED I ATTEMPTED TO FLUSH THROUGH THE TUBING AND WAS UNABLE TO GET ANYTHING THROUGH. THE TUBING USED WAS THE BD MAX XERO FILTERED MICROTUBING WITH A LOT NUMBER 244079130 BBRAUN ALARMING DOWNSTREAM. OCCLUSION WITH BD MAXZERO FILTERED MICROTUBING TUBING CHANGED AND ABLE TO INFUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21767144 ↗MalfunctionMar 31, 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: MEDLINE LEAKING FLUID/MEDICATIONS ONTO PATIENT BED FROM THE FILTER DURING ADMINISTRATION OF FLUIDS/MEDICATION. THE CHARGE NURSE WAS NOTIFIED AND THE MEDLINE REMOVED AND SEQUESTERED. REPLACEMENT MEDLINE DID NOT HAVE THE SAME ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21735743 ↗MalfunctionMar 3, 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 IT WAS REPORTED BY CUSTOMER THAT FILTER TUBING LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21511214 ↗MalfunctionFeb 3, 2025Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21296236 ↗MalfunctionNov 27, 2024Leak/Splash; Leak/Splash
MATERIAL: MZ9226 BATCH#: 24069401 IT WAS REPORTED BY THE CUSTOMER THAT THE FILTER PORTION OF THE MICRO TUBING WAS LEAKING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED THE FILTER PORTION OF THE MICRO TUBING WAS LEAKING. ITEM -MZ9226. LOT -24069401.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20800235 ↗MalfunctionNov 18, 2024Leak/Splash; Leak/Splash
MATERIAL# MZ9226 AND BATCH# 24079130. IT WAS REPORTED BY CUSTOMER THAT DURING A LINE CHANGE THE LINE SNAPPED APART AT THE FILTER CONNECTION. VERBATIM: DURING A LINE CHANGE THE LINE SNAPPED APART AT THE FILTER CONNECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20709504 ↗MalfunctionOct 30, 2024Leak/Splash; Leak/Splash
MATERIAL #: MZ9226 . BATCH#: UNKNOWN (24059449). IT WAS REPORTED BY CUSTOMER THAT LEAKING SEEN ON TUBING ON SIDE OF FILTER DISTAL TO THE PATIENT CONNECTION. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. LEAKING SEEN ON TUBING ON SIDE OF FILTER DISTAL TO THE PATIENT CONNECTION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20569390 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.