MaxGuard MA3131Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885403235825), received between Nov 22, 2021 and May 13, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2024Defective Component; Defective Component

  MATERIAL # MA3131 BATCH # UNKNOWN IT WAS REPORTED BY CUSTOMER THAT ROLLING CLAMP WOULD NOT ENGAGE CAUSING ENTIRE BAG OF IV FLUIDS TO LEAK ONTO FLOOR. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INJURIES OR ADVERSE EVENT: NO MEDLINE REFERENCE #: 200612787 ITEM: MA3131 QUANTITY AFFECTED: 1 EA SERIAL/LOT NUMBER: NA PO #: 4516816688 ARE ANY SAMPLES AVAILABLE FOR RETURN? YES REPORTED ISSUE PER CUSTOMER: WHILE PRIMING 500ML NORMAL SALINE BOLUS ON MAXGUARD 10 DROP ADMINISTRATION SET, ATTEMPTED TO CLAMP LINE PRIOR TO CONNECTING TO PATIENT, BUT ROLLING CLAMP WOULD NOT ENGAGE CAUSING ENTIRE BAG OF IV FLUIDS TO LEAK ONTO FLOOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19304734 ↗
• MalfunctionSep 1, 2023Material Separation; Material Separation

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17674714 ↗
• MalfunctionApr 17, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD MAXGUARD ADMINISTRATION SET LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LATE 60'S FEMALE WITH HISTORY OF ATRIAL FIBRILLATION. PROCEDURE: ABLATION AF. MAXGUARD 10CC DROP ADMINISTRATION TUBING LEAKING AT THE LEUER LOCK HUB. THE TUBING IS STERILE AND CONNECTED TO A SIDE PORT OF A SHEATH THAT EXTENDS INTO THE LEFT ATRIUM OF THE HEART. THIS COULD POTENTIALLY INTRODUCE AIR INTO THE BODY. TUBING REMOVED WITHOUT DIFFICULTY AND A NEW SET USED. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR SET, ADMINISTRATION, INTRAVASCULAR, MAXGUARD (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16757426 ↗
• MalfunctionMar 14, 2023Fluid/Blood Leak

  LATE 60¿S FEMALE WITH HISTORY OF ATRIAL FIBRILLATION. PROCEDURE: ABLATION AF. MAXGUARD 10CC DROP ADMINISTRATION TUBING LEADING AT THE LEUER LOCK HUB. THE TUBING IS STERILE AND CONNECTED TO A SIDE PORT OF A SHEATH THAT EXTENDS INTO THE LEFT ATRIUM OF THE HEART. THIS COULD POTENTIALLY INTRODUCE AIR INTO THE BODY. TUBING REMOVED WITHOUT DIFFICULTY AND A NEW SET USED. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR SET, ADMINISTRATION, INTRAVASCULAR, MAXGUARD (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16536628 ↗
• MalfunctionDec 28, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD MAXGUARD¿ ADMINISTRATION SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THIS STERILE IV TUBING IS CONNECTED TO A STOPCOCK, IT LEAKS AROUND THE THREADING EVEN IF IT IS THREADED/TIGHTLY CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16064812 ↗
• MalfunctionDec 9, 2022Fluid/Blood Leak; Connection Problem

  BD MAXGUARD 10 DROP ADMIN SET- WHEN THIS STERILE IV TUBING IS CONNECTED TO A STOPCOCK, IT LEAKS AROUND THE THREADING EVEN IF IT IS THREADED/TIGHTLY CORRECTLY. THIS LINE IS CONNECTED TO A SHEATH THAT GOES INTO THE LEFT ATRIUM OF THE HEART AND COULD INTRODUCE AIR IF THE TUBING IS LEAKING. WE CONNECT THIS TUBING TO A BAG OF FLUID UNDER PRESSURE. I CANNOT INCLUDE THE FLUID BAG AND PRESSURE BAG BECAUSE WE SWITCH OUT THE TUBING AND CONTINUE TO USE THE FLUID BAG UNDER PRESSURE. WE ALWAYS CHECK THIS CONNECTION BEFORE THE IV TUBING IS EVER CONNECTED TO THE SHEATH (CONNECTED TO THE PATIENT). THIS IS EVENT NUMBER 5 FOR THIS SAME PRODUCT- PLEASE REFER TO 2022-8109, 2022-8110 AND 2022-8112. MANUFACTURER RESPONSE FOR SET, ADMINISTRATION, INTRAVASCULAR, MAXGUARD (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15949682 ↗
• MalfunctionDec 6, 2022Fluid/Blood Leak

  BDMAXGUARD USED FOR PROCEDURE IN THE INVASIVE HEART LAB. WHEN THE STERILE IV TUBING WAS CONNECTED TO 3 PORT MANIFOLD, THE LUERLOCK DID NOT THREAD CORRECTLY AND LEAKED. DESPITE NUMEROUS REPOSITIONS, IT WOULD NOT QUIT LEAKING FLUID. THIS COULD POTENTIALLY ALLOW AIR INTO THE SYSTEM AND COULD ENTER A PATIENT'S HEART- CAUSING AN EMBOLISM. TUBING REPLACE WITH A SECOND SET- THE SAME RESULTS. IT WOULD NOT QUIT LEAKING. THE THIRD SET WAS USED WITHOUT FURTHER ISSUES. NO KNOWN HARM TO THE PATIENT, DELAY IN PROCEDURE. MANUFACTURER RESPONSE FOR SET, ADMINISTRATION, INTRAVASCULAR, MAXGUARD (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15923901 ↗
• MalfunctionDec 6, 2022Fluid/Blood Leak

  BDMAX USED FOR PROCEDURE IN INVASIVE HEART LAB. WHEN STERILE IV TUBING WAS CONNECTED TO 3 PORT MANIFOLD, THE LUERLOCK DID NOT THREAD CORRECTLY AND LEAKED. DESPITE THE NUMEROUS TIME IT WAS REPOSITIONED AND THREADED, IT WOULD NOT QUIT LEAKING FLUID. TUBING REPLACED WITH A SECOND SET WITHOUT FURTHER ISSUES. NO KNOWN HARM TO PATIENT, DELAY IN PROCEDURE. PLEASE REFER TO REPORT 2022-8109. SAME PRODUCT REPORTED PRIOR- ONE OF THESE HAS THE SAME LOT NUMBER. MANUFACTURER RESPONSE FOR SET, ADMINISTRATION, INTRAVASCULAR, MAXGUARD (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15923849 ↗
• MalfunctionDec 6, 2022Fluid/Blood Leak; Incomplete or Inadequate Connection

  BDMAX USED FOR PROCEDURE IN INVASIVE HEART LAB. WHEN STERILE IV TUBING WAS CONNECTED TO 3 PORT MANIFOLD, THE LUERLOCK DID NOT THREAD CORRECTLY AND LEAKED. DESPITE THE NUMEROUS TIME IT WAS REPOSITIONED AND THREADED, IT WOULD NOT QUIT LEAKING FLUID. TUBING REPLACED WITH A SECOND SET WITHOUT FURTHER ISSUES. NO KNOWN HARM TO PATIENT, DELAY IN PROCEDURE. PLEASE SEE THAT THIS IS THE 4TH EVENT, 3RD REPORT ON THE SAME PRODUCT IN 2 DAYS. SEE 2022-8109 AND 2022-8110. MANUFACTURER RESPONSE FOR SET, ADMINISTRATION, INTRAVASCULAR, MAXGUARD (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15923685 ↗
• MalfunctionNov 22, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE BD MAXGUARD¿ ADMINISTRATION SETS PRIMARY PACKAGING WAS DISCOLORED AND YELLOWING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE IDENTIFIED A QUALITY ISSUE WITH STOCK OF MEDLINE ITEM NUMBER (98786) - SET ADMIN 84IN GRAVITY (REF. (B)(4)), WHICH PREVENTS THIS PRODUCT FROM BEING USED IN THE PRODUCTION OF OUR KITS. IT WAS FOUND THAT THERE IS YELLOWING ON COMPONENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12856093 ↗