MaxZero MZ9292Recalls & reported problems
BD Switzerland Sàrl · Microbore bi-fuse extension set, 2 removable IV connectors, check valve 18 cm (7 in) · Class 2
All models of MaxZero (47)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885403417887), received between Nov 9, 2021 and Mar 6, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash4
- Backflow1
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2025Crack; Crack
IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS CRACKED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT THEY NOTICED OPACITY ON SECUREMENT PIECE OF A QUAD-FUSE. THEY INSPECTED FURTHER AND SAW IT WAS CRACKED, BUT NOT LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21543449 ↗MalfunctionFeb 12, 2025Backflow; Backflow
IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR HAD BACKFLOW. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT N NOTICED THAT BLOOD WAS BACKING UP INTO THE TUBING OF THE BLUE LUMEN OF PT'S NEOPICC. RN WENT TO FLUSH EXTENSION TUBING ON NEOPICC, LEAKING WAS NOTED WITH FLUSHING AND UPON FURTHER INSPECTION WITH RN XXX, BLACK LUMEN QUAD FUSE NOTED TO BE CRACKED AND TUBING BREAKING WITH 0.4 MEDLINE TUBING AND BIFUSES BREAKING OFF SPONTANEOUSLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21370875 ↗MalfunctionFeb 12, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS DISCONNECTING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT N NOTICED THAT BLOOD WAS BACKING UP INTO THE TUBING OF THE BLUE LUMEN OF PT'S NEOPICC. RN WENT TO FLUSH EXTENSION TUBING ON NEOPICC, LEAKING WAS NOTED WITH FLUSHING AND UPON FURTHER INSPECTION WITH RN XXX, BLACK LUMEN QUAD FUSE NOTED TO BE CRACKED AND TUBING BREAKING WITH 0.4 MEDLINE TUBING AND BIFUSES BREAKING OFF SPONTANEOUSLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21370797 ↗MalfunctionFeb 12, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY CUSTOMER THAT N NOTICED THAT BLOOD WAS BACKING UP INTO THE TUBING OF THE BLUE LUMEN OF PT'S NEOPICC. RN WENT TO FLUSH EXTENSION TUBING ON NEOPICC, LEAKING WAS NOTED WITH FLUSHING AND UPON FURTHER INSPECTION WITH RN XXX, BLACK LUMEN QUAD FUSE NOTED TO BE CRACKED AND TUBING BREAKING WITH 0.4 MEDLINE TUBING AND BIFUSES BREAKING OFF SPONTANEOUSLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21370795 ↗MalfunctionNov 19, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD EX SET BI-FUSE 7" MICRO 1CV REM CON TUBING WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE NOW GOTTEN MULTIPLE COMMENTS NOW ABOUT FLUID LEAKING FROM THE MAX ZERO CONNECTION SITE. IT IS NOT HAPPENING WITH SPIN COLLAR LUER CONNECTIONS, BUT RATHER WITH SYRINGES THAT ARE BEING PLACED ON THE MAX ZERO BIFUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12849414 ↗MalfunctionNov 9, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 1 BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR(S) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON A DIFFERENT NOTE, THERE HAVE BEEN A FEW SCENARIOS WHERE RNS HAVE NOTICED FLUID LEAKING NEAR THE MAX ZERO SITE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12783378 ↗
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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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