MaxGuard ME1225Recalls & reported problems
BD Switzerland Sàrl · Extension Set, with 1.2 Micron Filter 38 cm (15 in) · Class 2
All models of MaxGuard (49)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885403236129), received between Mar 27, 2023 and Dec 2, 2024 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (6 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
- Leak/Splash6
- Complete Blockage4
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Insufficient Information6
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20825147 ↗MalfunctionNov 7, 2023Leak/Splash; Leak/Splash
NO ADDITIONAL INFO.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18089029 ↗MalfunctionOct 13, 2023Leak/Splash; Leak/Splash
MalfunctionOct 13, 2023Leak/Splash; Leak/Splash
NO ADDITIONAL INFO.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17935020 ↗MalfunctionOct 13, 2023Complete Blockage; Complete Blockage
NO ADDITIONAL INFO.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17935018 ↗MalfunctionOct 12, 2023Leak/Splash; Leak/Splash
NO ADDITIONAL INFO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17925576 ↗MalfunctionOct 12, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED WHILE USING BD EXTENSION SET 1.2 MICRON FILTER THE DEVICE WAS DAMAGED AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: JUST WANTED TO UPDATED EVERYONE ON THIS EVENT THAT JUST OCCURRED IN THE NICU WITH THE 1.2 MICRON LIPID FILTER ME1225. THE LIPIDS WERE LEAKING FROM THE CIRCULAR AREA ON THE BACK SIDE OF THE FILTER. ONCE WE REPLACED THE FILTER, I WAS ABLE TO FLUSH FREELY THROUGH THE FILTER. A NEW FILTER CONNECTOR WAS REPLACED. ONE OF THE NURSES IN MED-SURG HAD THIS SAME PROBLEM WITH THE ME1225 (EXTENSION SET WITH 1.2 MICRON FILTER) AS WELL. THEY PULLED ANOTHER AND HAD NO ISSUES. THEY ALSO SAVED IT, AND I AM HAVING THE SAME ISSUE.
Patient problems: Insufficient Information
MAUDE report 17925512 ↗MalfunctionOct 12, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED THAT 2 OF THE BD EXTENSION SET 1.2 MICRON FILTER WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: XXXX CI STATING WHEN THEY PAUSE THE PUMP THE FILTER GET CLOGGED.
Patient problems: Insufficient Information
MAUDE report 17924900 ↗MalfunctionOct 11, 2023Break; Break
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17917319 ↗MalfunctionOct 11, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: I JUST HAD AN ISSUE REPORTED FROM THIS WEEKEND TO ME ABOUT THE LIPID FILTER "OCCLUDING" AFTER BEING PAUSED FOR AN INFUSION AND THE NURSE TRIED TO FLUSH IT. WHEN HE TRIED TO FLUSH IT, THE FILTER BROKE OPEN AND LIPIDS LEAKED EVERYWHERE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17917286 ↗MalfunctionMar 27, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE BD MAXGUARD¿ EXTENSION SET WAS BLOCKED AT THE FILTER DURING THE INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE BEEN EXPERIENCING INFUSION RELATED ISSUES WITH THE FOLLOWING BD 1.2 MICRON TUBING SETS. NURSING IS EXPERIENCING ISSUES WITH THE MEDICATION NOT BEING ABLE TO PROCEED PAST THE FILTER IN THE LINE. WE ARE NOW ON OPTION 3 AS PRESENTED BY THE BD REP AND WE ARE STILL EXPERIENCING THE SAME ISSUE. WHAT WE HAVE TRIED SO FAR REF # (B)(4). REF # (B)(4). REF# (B)(4). WE HAVE NOT REACHED OUT TO BD WITH THE CURRENT ISSUE WE ARE EXPERIENCING BUT WE HAVE SENT OFF PRODUCTS WHEN USING THE FIRST PRODUCT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16625032 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page