MaxZero MZ1000Recalls & reported problems
BD Switzerland Sàrl · Needleless Connector · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This BD MaxZero needleless connector has 374 reports, with no deaths and 3 injuries. Most describe malfunctions such as fluid leaking, complete blockages, cracks and backflow, and a few mention bleeding. No recalls name this device. Recent reports rose from 62 to 132 compared with the period before.
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
- 379
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 379 adverse event reports that list this exact device (DI 10885403224782), received between May 20, 2021 and Sep 29, 2026 — classified as 2 injuries, 377 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (156 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/Splash156
- Complete Blockage74
- Crack51
- Fluid/Blood Leak33
- Obstruction of Flow23
- Backflow22
- Disconnection12
- Loose or Intermittent Connection9
Patient problems
- No Clinical Signs, Symptoms or Conditions341
- Insufficient Information31
- Hemorrhage/Blood Loss/Bleeding3
- Bacterial Infection1
- Cardiac Arrest1
- Chemical Exposure1
- Discomfort1
- Exposure to Body Fluids1
Recent adverse event reports
The 25 most recent of 379 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Backflow; Fluid/Blood Leak; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935055 ↗MalfunctionSep 28, 2026Contamination
Additional information:The feedback indicates that the residue was discovered inside the MaxZero housing on 7 Sept; however, it is unclear when the affected MZ1000 was first used; please confirm which date the MZ1000 was used from: - The hospital policy regarding the maximum interval between MaxZero replacements is to replace them at the same time as the IV set (at least once every week); however, since there are no records indicating whether this was properly followed in this case, it is unclear (it is possible that the MaxZero was never replaced after the PICC was inserted).Please clarify why the user believes that the MZ1000 is the cause of the observed residue:-We believe the issue stems from improper use¿possibly because the replacement was not performed correctly¿but we also believe that the Max Zero itself is designed in such a way that solution tends to remain even when the pulsed flash is performed correctly.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913800 ↗MalfunctionSep 23, 2026Complete Blockage
It was reported, Maxzero, Unable to flush, during use. The following was provided by the initial reporter: Contaminated with chemical solution (unknown). According to the customer report an exchange was made on (b)(6), but when tried to flush the solution, it wouldn't flow during use.additional information:Could you please check the lot number? It is unknown.Was the defect observed during priming or during infusion? If during infusion, how much time had elapsed? We have not checked the details.Could you please check the manufacturer name and model number of the product connected to the MaxZero? Terumo (for the IV line).Could you please check the set for visible damage such as cracks, burrs, or piston deformation? There appears to be no damage, but please check it just in case.Could you please check what medication was being infused when the incident occurred? Unknown.Did the patient suffer any harm? Confirmed that there was no harm.Was the infusion volume insufficient? Unknown.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868466 ↗MalfunctionSep 23, 2026Leak/Splash; Connection Problem
It was reported, Maxzero, connection issues, causing leak.The following was provided by the initial reporter: During the procedure to insert an IV cannula on (b)(6) 2026, the nurse connected a clear, cannula-free connector to the patient. The connector did not lock securely, causing fluid leakage. The nurse immediately replaced it with a new clear, cannula-free connector.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50868130 ↗MalfunctionSep 22, 2026Infusion or Flow Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860021 ↗MalfunctionSep 22, 2026Fluid/Blood Leak
It was reported, Maxzero, leakage. The following was provided by the initial reporter: "Leakage at the valve and tubing". Risk that the patient may not receive the full infusion.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854434 ↗MalfunctionSep 21, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834927 ↗MalfunctionSep 17, 2026Leak/Splash
It was reported, Maxzero, leakage.The following was provided by the initial reporter: On (b)(6) 2026, at 10:10 a.m., while the patient was receiving an intravenous infusion of 500 ml of saline, 2.3 g of ifosfamide for injection, and 25 ml of sterile water for injection, fluid leaked from the clear, needle-free cannula of the patient¿s internal jugular vein tube. The clear, needle-free cannula was immediately replaced, and the patient continued treatment.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802869 ↗MalfunctionSep 15, 2026Contamination
It was reported, Maxzero, foreign matter.It was reported that on (b)(6), a Power PCC (3275118J) was inserted, and a Max Zero -(MZ1000) was attached at that time. On (b)(6), residual material was visually detected inside the Max Zero during use. It was exchanged immediately. It is unclear when the residual material formed.additional information:Please provide the lot number of the MZ1000 product: 25115641.Please clarify why the customer believes that the contamination originated from within the MZ1000 product, if it had already been in use for several days and had multiple solutions pass through it: Since it was visually confirmed that debris was present inside the product.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50773799 ↗MalfunctionSep 14, 2026Crack; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765275 ↗MalfunctionSep 14, 2026Crack; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765258 ↗MalfunctionSep 14, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50753076 ↗MalfunctionSep 14, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50753075 ↗MalfunctionSep 13, 2026Backflow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747884 ↗MalfunctionSep 8, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50670404 ↗MalfunctionSep 8, 2026Contamination
No additional information.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50670401 ↗MalfunctionSep 8, 2026Crack; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50669072 ↗MalfunctionSep 8, 2026Crack
It was reported, Maxzero, cracked during use.The following was provided by the initial reporter: This is a report about cracks in the housing observed during use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50669071 ↗MalfunctionSep 4, 2026Leak/Splash
MalfunctionAug 5, 2026Contamination
MalfunctionJul 30, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50083008 ↗MalfunctionJul 27, 2026Failure to Unfold or Unwrap
No additional information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50035900 ↗MalfunctionJul 27, 2026Crack; Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50022118 ↗MalfunctionJul 1, 2026Complete Blockage
IT WAS REPORTED, MAXZERO, OCCLUSION. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2026, TUMOR AREA B NEEDED TO FLUSH THE TUBING DURING THE MAINTENANCE OF PICC FOR A PATIENT, BUT THE TRANSPARENT NEEDLELESS CONNECTOR WAS OBSTRUCTED AND COULD NOT BE FLUSHED; AFTER ADJUSTING THE CATHETER, IT STILL DID NOT FLOW SMOOTHLY; AFTER REMOVING THE TRANSPARENT NEEDLELESS CONNECTOR AND DRAWING BLOOD, THE BLOOD WAS DRAWN AND THE FLUSHING TUBE FLOWED SMOOTHLY, AND THE CATHETER WAS CLOSED SMOOTHLY AFTER REPLACING THE TRANSPARENT NEEDLELESS CONNECTOR WITH A NEW ONE.
Patient problems: Insufficient Information
MAUDE report 25677973 ↗MalfunctionJun 17, 2026Leak/Splash
IT WAS REPORTED, MAXZERO, LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY INITIAL REPORTER: ON (B)(6) 2025 AT 08:00, THE CONNECTOR WAS FOUND TO BE LEAKING WHEN THE NURSE PICKED IT UP TO ADMINISTER FLUIDS TO A PATIENT. PRODUCT QUALITY WAS SUSPECTED, THE CONNECTOR WAS REPLACED AND REPORTED TO THE MEDICAL DEVICES DEPARTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25534554 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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