MaxZero MZ9281Recalls & reported problems
BD Switzerland Sàrl · Minibore tri-fuse extension set, 3 IV connectors, 3 check valves 13.5 cm (5 in) · Class 2
All models of MaxZero (47)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BD MaxZero minibore tri-fuse extension set is a short IV tubing set with three connectors and check valves, used to extend central lines such as those for chemotherapy. The 53 reports mostly describe the tubing or its Luer collar cracking, sometimes along with leaks, breaks, or blocked flow; none describe patient injuries or deaths. Reports rose from 14 in the prior 12 months to 35 in the most recent 12 months. 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
- 51
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10885403230646), received between Feb 7, 2019 and Jul 10, 2026 — classified as 51 malfunctions.
The most frequently reported specific device problem is “Crack” (33 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
- Crack33
- Leak/Splash6
- Break4
- Complete Blockage3
- Activation, Positioning or Separation Problem2
- Connection Problem1
- Detachment of Device or Device Component1
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions49
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25784684 ↗MalfunctionJul 10, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25782774 ↗MalfunctionJul 10, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25781944 ↗MalfunctionJul 10, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25781942 ↗MalfunctionJun 17, 2026Crack
IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS CRACKED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED THAT NINE OF THE MAXZERO WERE CRACKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25541775 ↗MalfunctionJun 4, 2026Crack
IT WAS REPORTED THAT THE BD MAXZERO MINIBORE TRI-FUSE EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR PEDIATRIC UNITS RECENTLY IMPLEMENTED BD MZ9281 (PS (B)(4), AND WE HAVE NOW RECEIVED 7 REPORTS OF THE LUER COLLAR CRACKING. INJURIES OR ADVERSE EVENT: NO. ITEM: MZ9281. QUANTITY AFFECTED:7 EACH. SERIAL/LOT NUMBER: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25393430 ↗MalfunctionJun 4, 2026Crack
IT WAS REPORTED THAT THE BD MAXZERO MINIBORE TRI-FUSE EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR PEDIATRIC UNITS RECENTLY IMPLEMENTED BD MZ9281 (PS#340381), AND WE HAVE NOW RECEIVED 7 REPORTS OF THE LUER COLLAR CRACKING. INJURIES OR ADVERSE EVENT: NO. ITEM: MZ9281. QUANTITY AFFECTED:7 EACH. SERIAL/LOT NUMBER: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25393427 ↗MalfunctionJun 4, 2026Crack
IT WAS REPORTED THAT THE BD MAXZERO MINIBORE TRI-FUSE EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR PEDIATRIC UNITS RECENTLY IMPLEMENTED BD MZ9281 (PS#340381), AND WE HAVE NOW RECEIVED 7 REPORTS OF THE LUER COLLAR CRACKING. INJURIES OR ADVERSE EVENT: NO. ITEM: MZ9281. QUANTITY AFFECTED:7 EACH. SERIAL/LOT NUMBER: (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25393408 ↗MalfunctionMay 27, 2026Crack
IT WAS REPORTED THAT THE BD MAXZERO EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR PEDIATRIC UNITS RECENTLY IMPLEMENTED MZ9281, AND WE HAVE NOW RECEIVED 5 REPORTS OF THE LUER COLLAR CRACKING. ALL WERE LOT 25085808. PLEASE MENTION THE AFFECTED NUMBER OF PATIENTS WITH RESPECT TO THE EVENT DATES. 4 DESCRIBE ANY PATIENT¿S HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. CHEMOTHERAPY EXPOSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25305890 ↗MalfunctionMay 27, 2026Crack
IT WAS REPORTED THAT THE BD MAXZERO EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR PEDIATRIC UNITS RECENTLY IMPLEMENTED MZ9281, AND WE HAVE NOW RECEIVED 5 REPORTS OF THE LUER COLLAR CRACKING. ALL WERE LOT 25085808. PLEASE MENTION THE AFFECTED NUMBER OF PATIENTS WITH RESPECT TO THE EVENT DATES. 4 DESCRIBE ANY PATIENT¿S HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. CHEMOTHERAPY EXPOSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25305857 ↗MalfunctionMay 20, 2026Leak/Splash
IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY A CUSTOMER THAT THE LUER COLLAR WAS CRACKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25231359 ↗MalfunctionMay 20, 2026Leak/Splash
IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IT WAS REPORTED BY A CUSTOMER THAT THE LUER COLLAR WAS CRACKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25231358 ↗MalfunctionMay 20, 2026Leak/Splash
IT WAS REPORTED THAT BD MAXZERO EXTENSION SET WAS CRACKED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY A CUSTOMER THAT THE LUER COLLAR WAS CRACKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25231352 ↗MalfunctionApr 3, 2026Crack
IT WAS REPORTED BY CUSTOMER THAT BD EXTENSION SETS ¿CRACKING¿.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24778812 ↗MalfunctionApr 3, 2026Crack
IT WAS REPORTED BY CUSTOMER THAT BD EXTENSION SETS ¿CRACKING¿.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24778459 ↗MalfunctionApr 2, 2026Crack
IT WAS REPORTED BY CUSTOMER THAT BD EXTENSION SETS ¿CRACKING¿.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767676 ↗MalfunctionApr 2, 2026Crack
IT WAS REPORTED BY CUSTOMER THAT BD EXTENSION SETS ¿CRACKING¿.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767675 ↗MalfunctionApr 2, 2026Crack
IT WAS REPORTED BY CUSTOMER THAT BD EXTENSION SETS ¿CRACKING¿.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767659 ↗MalfunctionApr 2, 2026Crack
IT WAS REPORTED BY CUSTOMER THAT BD EXTENSION SETS ¿CRACKING¿.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767654 ↗MalfunctionApr 2, 2026Crack
IT WAS REPORTED BY CUSTOMER THAT BD EXTENSION SETS ¿CRACKING¿.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767652 ↗MalfunctionApr 2, 2026Crack
IT WAS REPORTED BY CUSTOMER THAT BD EXTENSION SETS ¿CRACKING¿.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767425 ↗MalfunctionApr 2, 2026Crack
IT WAS REPORTED BY CUSTOMER THAT BD EXTENSION SETS ¿CRACKING¿.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767381 ↗MalfunctionApr 2, 2026Crack
IT WAS REPORTED BY CUSTOMER THAT BD EXTENSION SETS ¿CRACKING¿.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767380 ↗MalfunctionApr 2, 2026Crack
IT WAS REPORTED BY CUSTOMER THAT BD EXTENSION SETS ¿CRACKING¿.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767379 ↗MalfunctionApr 2, 2026Crack
IT WAS REPORTED BY CUSTOMER THAT BD EXTENSION SETS ¿CRACKING¿.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767378 ↗
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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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