MaxZero MZXT5306Recalls & reported problems
BD Switzerland Sàrl · Pressure Rated Extension Sets, Removable IV Connector, T-Connector 16cm (6in) · Class 2
All models of MaxZero (47)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885403463815), received between Dec 8, 2025 and Jun 27, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Connection Problem” (2 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.
Reports received per month
Most reported problems
Device problems
- Connection Problem2
- Crack1
- Fluid/Blood Leak1
- Loose or Intermittent Connection1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2026Loose or Intermittent Connection
IT WAS REPORTED THAT THE BD MAXZERO PRESSURE RATED EXTENSION SET HAD CONNECTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MY CUSTOMER HAD TROUBLE ATTACHING THE EXTENSION TO OUR CATHETERS (WHICH CAUSED SOME LEAKING) AND WOULD LIKE TO RETURN THE SUBSTITUTE THEY BROUGHT IN. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN THIS FORMAT MM-DD-YYYY? VARIOUS COMPLAINTS SINCE THIS WAS BROUGHT IN. WE HAVE REACHED OUT TO BD ABOUT IT SEVERAL TIMES AS WE WERE LOOKING AT OTHER OPTIONS AVAILABLE. PLEASE SHARE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE NO PARTICULAR LOT IMPACTED. SEEMS TO BE ALL. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO HARM. WE HAVE BEEN WORKING WITH (B)(6) ON THIS ISSUE. THERE HAVE BEEN REPORTS FROM THE SYSTEM AS A WHOLE ABOUT THE SETS NOT SECURING PROPERLY TO OUR TUBING AND DISCONNECTING WHEN LITTLE PRESSURE IS APPLIED, WHICH CAUSES LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25645545 ↗MalfunctionFeb 26, 2026Material Integrity Problem
IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT NEAREST PORT OF EXTENSION SET "EXPLODED" UPON A POWER INJECTION AND DISPLACED THE SILICONE WITHIN THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24462487 ↗MalfunctionDec 20, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET HAD CONNECTION ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT T-PORT LUER LOCK CONNECTION ISSUES, UNABLE TO SECURE IV HUB TO SPIN COLLAR. SECOND CASE WITH ISSUES FROM THIS SAME LOT NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23858988 ↗MalfunctionDec 8, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET HAD CONNECTION ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIMIT WAS REPORTED BY CUSTOMER THAT THE T CONNECTOR ON EXTENSION SET MZXT5306 IS NOT SECURELY FITTING ON THE END OF IV HUB, LEADING TO LEAKING OF BLOOD AND MEDICATION. THE LUER LOCK CONNECTION IS NOT SEATING PROPERLY TO IV HUB, LEADING TO NURSES SPINNING THE SPIN COLLAR AND, IN SOME CASES, CRACKING IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23751716 ↗MalfunctionDec 8, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT BD MAXZERO PRESSURE RATED EXTENSION SET WAS CRACKED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THE T CONNECTOR ON EXTENSION SET MZXT5306 IS NOT SECURELY FITTING ON THE END OF IV HUB, LEADING TO LEAKING OF BLOOD AND MEDICATION. THE LUER LOCK CONNECTION IS NOT SEATING PROPERLY TO IV HUB, LEADING TO NURSES SPINNING THE SPIN COLLAR AND, IN SOME CASES, CRACKING IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23751713 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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