MaxGuard ME2010Recalls & reported problems
BD Switzerland Sàrl · Extension Set (minibore) 152.4 cm (60 in) · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10885403236235), received between Jun 4, 2019 and Feb 12, 2026 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Defective Component” (7 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Jun 16, 2026Open, Classified
Due to mechanical issue with internal sterilization equipment resulting in potential underdosing of product during processing, which may have resulted in products not being sterilized correctly.
Z-2941-2026 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Defective Component7
- Leak/Splash5
- Break2
- Crack2
- Complete Blockage1
- Connection Problem1
- Difficult or Delayed Separation1
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- Insufficient Information4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2026Disconnection
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24322458 ↗MalfunctionFeb 11, 2026Break
IT WAS REPORTED THAT THE PROBLEM I KEEP HEARING ABOUT IS THE CLAVE BECOMING STUCK ON THE TUBING AND HAVING DIFFICULTY GETTING IT OFF. THEY ARE HAVING DIFFICULTY DISCONNECTING OR ARE UNABLE TO DISCONNECT THE SYRINGE IV TUBING FROM THE CLAVE AND EVENTUALLY THE MALE LUER OF THE IV TUBING IS BREAKING OFF AND REMAINING IN THE CLAVE'S ACCESS PORT.
Patient problems: Insufficient Information
MAUDE report 24317464 ↗MalfunctionOct 27, 2025Complete Blockage; Complete Blockage
MalfunctionOct 27, 2025Break; Break
MalfunctionAug 19, 2025Defective Component; Connection Problem; Defective Component; Connection Problem
NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22844047 ↗MalfunctionAug 19, 2025Defective Component; Defective Component
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT SOME CONTRAST REMAINS IN THE LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22844038 ↗MalfunctionJul 28, 2025Defective Component; Defective Component
IT WAS REPORTED THAT THE BD MAXGUARD EXTENSION SET HAD A LOOSE TUBING CLAMP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ME2010 TUBING CLAMP NOT CLAMPING AS IT SHOULD AND ALLOWING MEDICATION, DIPRIVAN, TO LEAK OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22639870 ↗MalfunctionJul 28, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT TUBING CLAMP NOT CLAMPING AS IT SHOULD AND ALLOWING MEDICATION, DIPRIVAN, TO LEAK OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22634275 ↗MalfunctionMay 12, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY THE CUSTOMER THAT THE TUBING BROKE OFF AT IV ACCESS OF PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22001774 ↗MalfunctionMar 21, 2025Defective Component; Defective Component
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21665726 ↗MalfunctionMar 3, 2025Defective Component; Defective Component
MalfunctionSep 9, 2024Leak/Splash; Defective Component; Leak/Splash; Defective Component
IT WAS REPORTED BD MAXGUARD EXTENSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: THE STAFF DID HAVE A ME2010, AND THE TUBING DIAMETER IS TOO SMALL, IS THERE SOMETHING THAT BD CAN OFFER THAT IS 2.2ML THE MEDICATION IS COMING OUT WHEN THEY ARE USING ME2010. THE STAFF DID HAVE A ME2010, AND THE TUBING DIAMETER IS TOO SMALL, IS THERE SOMETHING THAT BD CAN OFFER THAT IS 2.2ML?
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20169750 ↗MalfunctionJul 8, 2024Obstruction of Flow; Infusion or Flow Problem; Obstruction of Flow; Infusion or Flow Problem
NO ADDITIONAL INFO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19696379 ↗MalfunctionApr 18, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ACCOUNT USING BD #ME2010 IN PEDES HAD LEAKING 3 TIMES. PRODUCT#: ME2010 LOT#: 24029290.
Patient problems: Insufficient Information
MAUDE report 19132141 ↗MalfunctionApr 3, 2024Defective Component; Defective Component
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19038450 ↗MalfunctionJan 18, 2023Crack; Leak/Splash; Crack; Leak/Splash
IT WAS REPORTED THAT THE BD MAXGUARD¿ EXTENSION SET TUBING CRACKED AND LEAKED WHILE HANGING NEW FLUIDS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD AN ISSUE TODAY WHERE A BD MAXGUARD EXTENSION SET CRACKED IN USE... WHEN HANGING NEW FLUIDS ON AN ADMISSION THE 0.3 ML TUBING CRACKED WHERE THE NAD MET THE TUBING. NEW TUBING WAS OBTAINED SEMS 965896."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16200417 ↗MalfunctionAug 18, 2021Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT 60 IN NON-DEHP MINIBORE EXTENSION SET TUBING WAS KINKED AND THE HUB WAS LOOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE TUBING OFTEN KNOTS AND THE HUB ON THE MALE LUER END SPINS RATHER THAN BEING FIXED. VERBATIM: WE HAVE NOW TRIED FOR OVER 18 MONTHS TO WORK WITH THE BD PRODUCT, WITHOUT SUCCESS. WE CONTINUE TO CONFRONT TWO PROBLEMS: THE TUBING OFTEN KNOTS. THIS IS PARTICULARLY AN ISSUE WHEN THE TUBING IS CONNECTED WHILE STILL IN A COIL, BUT THEN IT TURNS OUT THAT INSTEAD OF OPENING UP INTO A NICE LONG LENGTH OF TUBING, ONE END GOT THREADED THROUGH THE COIL AND THERE'S A GIGANTIC KNOT. THE ICU MEDICAL TUBING HAD A PAPER WRAPPER THAT KEPT THIS FROM HAPPENING. THE HUB ON THE MALE LUER END SPINS RATHER THAN BEING FIXED. THIS IS ESPECIALLY PROBLEMATIC WHEN TRYING TO DISENGAGE THE MICROBORE TUBING FROM THE PORT THAT IT'S ATTACHED TO. AFTER THE HUB IS UNLOCKED, THERE IS NOTHING TO ALLOW ONE TO PULL. YOU INSTEAD HAVE TO ENGAGE THE HUB ON THE FLANGES ON THE INNER PLASTIC PIECE TO ALLOW YOU TO TWIST. BUT ANY PULLING MOTION DISENGAGES YOU FROM THE FLANGES, AND YOU HAVE TO START AGAIN. WE ARE FINDING THAT WE NE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12336514 ↗MalfunctionApr 20, 2021Leak/Splash; Difficult to Remove; Difficult or Delayed Separation; Leak/Splash; Difficult to Remove; Difficult or Delayed Separation
IT WAS REPORTED THAT 60 IN NON-DEHP MINIBORE EXTENSION SET WAS DIFFICULT TO DISCONNECT AND THE TUBING RUPTURED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: ME2010 BATCH/LOT #: UNKNOWN. IT WAS REPORTED THAT THEY ARE EXPERIENCING ISSUES WITH THE TUBING WHEN TRYING TO DISCONNECT. VERBATIM: WE ARE EXPERIENCING ISSUES WITH DISCONNECTION BECAUSE THE TUBING FUNCTIONS DIFFERENTLY FROM OUR NORMAL TUBING. WE HAVE HAD MULTIPLE ISSUES WITH THE TUBING CRACKING/BREAKING WHEN TRYING TO DISCONNECT. I BELIEVE THE BREAKS ARE DUE TO FORCE AND LACK OF KNOWLEDGE ABOUT APPROPRIATE DISCONNECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11697843 ↗MalfunctionJun 4, 2019Crack; Crack
IT WAS REPORTED THAT THE TUBING BROKE AT THE LUER LOCK CONNECTION TO THE SYRINGE AND DRIPPED ON THE PUMP AND LEAKED DURING ADMINISTRATION OF TRANEXAMIC ACID. NO PATIENT HARM WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8667272 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.