MaxGuard MX4450Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10885403274671), received between May 3, 2019 and Nov 5, 2025 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (9 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.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE(S) AND STOPCOCK HAD CONNECTION ISSUES (DISCONNECTION). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ANESTHESIA DEPARTMENT HAS BEEN HAVING SEVERAL ISSUES RELATED TO DISCONNECTIONS BETWEEN THE MX4450 STOPCOCK AND THE EXTENSION SET DURING SURGICAL PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480456 ↗
• MalfunctionNov 5, 2025Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE(S) AND STOPCOCK HAD CONNECTION ISSUES (DIFFICULT TO DISCONNECT). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ANESTHESIA DEPARTMENT HAS EXPERIENCED DIFFICULTY DISCONNECTING THE STOPCOCK FROM THE EXTENSION SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480446 ↗
• MalfunctionNov 5, 2025Crack; Crack

  IT WAS REPORTED THAT THE BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE(S) AND STOPCOCK WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ANESTHESIA DEPARTMENT HAS EXPERIENCED CRACKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23480445 ↗
• MalfunctionNov 5, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE(S) AND STOPCOCK HAD CONNECTION ISSUES (DISCONNECTION). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ANESTHESIA DEPARTMENT HAS BEEN HAVING SEVERAL ISSUES RELATED TO DISCONNECTIONS BETWEEN THE MX4450 STOPCOCK AND THE EXTENSION SET DURING SURGICAL PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479983 ↗
• MalfunctionAug 20, 2024Material Separation; Separation Failure; Material Separation; Separation Failure

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20001166 ↗
• MalfunctionDec 6, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD MAXGUARD EXTENSION SE T WITH NEEDLELESS Y-SITE(S) AND STOPCOCK WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: WE HAVE BEEN HAVING ISSUES WITH THE MX4450 EXTENSION SETS WITH 4-WAY STOPCOCKS. I KNOW WE HAD THE SAME PROBLEM MAYBE A YEAR AGO AND SOME BAD LOT #'S WERE IDENTIFIED. HAVE YOU HAD ANY REPORTS OF THIS HAPPENING WITH THE LOT # BELOW? THIS IS A SAFETY INCIDENT REPORTED BY OUR SURGERY TEAM. PLEASE SEE HIGHLIGHTED SECTIONS BELOW FOR THE INFO YOU MAY NEED TO REPORT THIS. THANK YOU. MATERIAL MX4450 LOT 22099402- SAMPLES ARE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18278773 ↗
• MalfunctionDec 6, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WITH NEEDLELESS Y-SITE(S) AND STOPCOCK WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING : WE HAVE BEEN HAVING ISSUES WITH THE MX4450 EXTENSION SETS WITH 4-WAY STOPCOCKS. I KNOW WE HAD THE SAME PROBLEM MAYBE A YEAR AGO AND SOME BAD LOT #'S WERE IDENTIFIED. HAVE YOU HAD ANY REPORTS OF THIS HAPPENING WITH THE LOT # BELOW? THIS IS A SAFETY INCIDENT REPORTED BY OUR SURGERY TEAM. HIGHLIGHTED SECTIONS BELOW FOR THE INFO YOU MAY NEED TO REPORT THIS. THANK YOU. MATERIAL MX4450 LOT 22099402- SAMPLES ARE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18278770 ↗
• MalfunctionJun 2, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 5 BD MAXGUARD¿ EXTENSION SETS WITH NEEDLELESS Y-SITE AND STOPCOCK WERE BLOCKED DURING THE PRIMING PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "5 REPORTS WHERE THE MAXGUARD EXTENSION SETS DO NOT PRIME AS A PATIENT IS BEING PREPARED FOR SURGERY. MULTIPLE REPORTS OF ATTEMPTING TO PRIME FOR PATIENT CARE AND IV FLUID SET UP FOR SURGERY AND THE SETS DO NOT PRIME WITH FLUID, THERE IS SOME KIND OF OCCLUSION WITHIN THE SET."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17048674 ↗
• MalfunctionMay 1, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD MAXGUARD¿ EXTENSION SET WITH NEEDLELESS Y-SITE AND STOPCOCK HAD FLOW ISSUES AND COULD NOT BE FLUSHED OR PRIMED WITH SALINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBING CANNOT BE FLUSHED OR PRIMED. "I HAVE RECEIVED 3 DEFECTIVE MX4450 BD MAXGUARD EXTENSION SET WITH TWO 4-WAY STOPCOCKS AND NEEDLELESS Y-SITE, INITIALLY RECEIVED ON (B)(6) AND THEN TWO MORE ON (B)(6), ALL 3 FROM PRE-OP ACU. THESE ALL DO NOT WORK - THEY CANNOT BE FLUSHED AND OR PRIMED. CUSTOMER REPORTED AN ADDITIONAL MX4450 ISSUES AND HAVE AN ADDITIONAL SET RECEIVED ON (B)(6)FROM LABOR AND DELIVERY... WERE THERE ANY ADVERSE EVENTS DUE TO THE REPORTED ISSUE? NO ADVERSE EVENTS. WAS ANY MEDICATION USED WITH THE PRODUCT? IF YES, WHAT WAS THE MEDICATION? NO MEDICATIONS - ONLY SALINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16842361 ↗
• MalfunctionApr 28, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED, WHILE USING BD 64" (163 CM) STDBORE EXT SET W/TWO 4-WAY. THERE WAS A BLOCKAGE. THIS IS 2 OF 2 RELATED REPORTS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED, BY THE CUSTOMER. THAT THE TUBING CANNOT BE FLUSHED OR PRIMED NEW COMPLAINT TO BE GENERATED, CAPTURES SETS FOR DATES OF EVENTS 4/7. AND 2 UNKNOWN DATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16829604 ↗
• MalfunctionApr 27, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD 64" (163 CM) STDBORE EXT SET W/TWO 4-WAY THERE WAS A BLOCKAGE. THIS IS 1 OF 2 RELATED REPORTS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE TUBING CANNOT BE FLUSHED OR PRIMED NEW COMPLAINT TO BE GENERATED- CAPTURES SETS FOR DATES OF EVENTS 4/7 AND 2 UNKNOWN DATES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16825696 ↗
• MalfunctionApr 18, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED,THAT THE BD MAXGUARD¿ EXTENSION SET WITH NEEDLELESS Y-SITE AND STOPCOCK TUBING WAS CLOGGED. THIS IS 3 OF 3 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING CANNOT BE FLUSHED OR PRIMED. "I HAVE RECEIVED 3 DEFECTIVE MX4450 BD MAXGUARD EXTENSION SET, WITH TWO 4-WAY STOPCOCKS AND NEEDLELESS Y-SITE. INITIALLY, RECEIVED ON 3/13 AND THEN TWO MORE ON 3/17, ALL 3 FROM PRE-OP ACU. THESE ALL DO NOT WORK. THEY CANNOT BE FLUSHED AND OR PRIMED ".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16762365 ↗
• MalfunctionApr 18, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD MAXGUARD¿ EXTENSION SET WITH NEEDLELESS Y-SITE AND STOPCOCK TUBING WAS CLOGGED. THIS IS 2 OF 3 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBING CANNOT BE FLUSHED OR PRIMED "I HAVE RECEIVED 3 DEFECTIVE MX4450 BD MAXGUARD EXTENSION SET WITH TWO 4-WAY STOPCOCKS AND NEEDLELESS Y-SITE, INITIALLY RECEIVED ON 3/13 AND THEN TWO MORE ON 3/17, ALL 3 FROM PRE-OP ACU. THESE ALL DO NOT WORK - THEY CANNOT BE FLUSHED AND OR PRIMED ".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16762364 ↗
• MalfunctionApr 13, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD MAXGUARD¿ EXTENSION SET WITH NEEDLELESS Y-SITE AND STOPCOCK TUBING WAS CLOGGED. THIS IS 1 OF 3 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THESE ALL DO NOT WORK - THEY CANNOT BE FLUSHED AND OR PRIMED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16740473 ↗
• MalfunctionOct 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BD MAXGUARD¿ EXTENSION SET WITH NEEDLELESS Y-SITE AND STOPCOCK DISCONNECTED IN THE MIDDLE OF THE TUBING WHILE THE PATIENT WAS RECEIVING SALINE VIA IV. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV TUBING WAS CONNECTED IN PERIOP BEFORE THE PATIENT ARRIVED IN MEDICAL/SURGICAL/ ORTHOPEDIC (MSO) POST OPERATIVELY. POST OPERATIVELY IN MSO THE PATIENT WAS RECEIVING NORMAL SALINE IV AND SITTING IN A CHAIR AT THE BEDSIDE. THE NURSE CAME IN AND NOTICED THE IV WAS DISCONNECTED IN THE MIDDLE OF THE TUBING, NOT NEAR ANY LUER CONNECTION. THE IV TUBING WAS CHANGED, NO HARM TO THE PATIENT. THE CHARGE NURSE CALLED QUALITY/RISK AND SECURED THE DEFECTIVE TUBING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15641420 ↗
• MalfunctionOct 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BD MAXGUARD EXTENSION SET DISCONNECTED FROM THE CENTER/MIDDLE OF THE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV WAS DISCONNECTED IN THE MIDDLE OF THE TUBING, NOT NEAR ANY LUER CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15636052 ↗
• MalfunctionOct 19, 2022Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BD MAXGUARD EXTENSION SET DISCONNECTED FROM THE CENTER/MIDDLE OF THE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV WAS DISCONNECTED IN THE MIDDLE OF THE TUBING, NOT NEAR ANY LUER CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15636026 ↗
• MalfunctionOct 4, 2022Defective Component; Defective Component

  IT WAS REPORTED WHILE USING BD 64" (163 CM) STDBORE EXT SET W/TWO 4-WAY THE TUBING WAS DEFECTIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECTIVE IV TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15535287 ↗
• MalfunctionOct 4, 2022Defective Component; Defective Component

  IT WAS REPORTED WHILE USING BD 64" (163 CM) STDBORE EXT SET W/TWO 4-WAY, THE TUBING WAS DEFECTIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECTIVE IV TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15535286 ↗
• MalfunctionSep 24, 2022Material Separation; Material Separation

  IT WAS REPORTED WHILE USING A BD 64" (163 CM) STDBORE EXT SET W/TWO 4-WAY THE TUBING WAS DEFECTIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN ADDITION, ANOTHER DEFECTIVE TUBING WAS IDENTIFIED BUT NOT REPORTED WITH A PATIENT EVENT. THE DEFECTIVE TUBING WAS DROPPED OFF IN MY OFFICE ON 9/9/2022. IT IS THE SAME LOT NUMBER ENDING IN X30.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15481558 ↗
• MalfunctionSep 24, 2022Material Separation; Material Separation

  IT WAS REPORTED WHILE USING BD MAXGUARD EXTENSION SET THE TUBING WAS DEFECTIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HOSPITAL HAS NOTIFIED US THAT THEY HAVE EXPERIENCED A DEFECTIVE IV TUBING SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15479907 ↗
• MalfunctionMay 3, 2019Disconnection; Loose or Intermittent Connection; Disconnection; Loose or Intermittent Connection

  CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "BD MAX ZERO -THE TUBING DOESN'T REMAIN CONNECTED, BUT INSTEAD BACKS OFF THE THREADED PIECE." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2019 WAS PROVIDED. CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "THE TUBING DOESN'T REMAIN CONNECTED, BUT INSTEAD BACKS OFF THE THREADED PIECE." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2019 WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8579912 ↗