MaxGuard ME1055Recalls & reported problems
BD Switzerland Sàrl · Extension Set, 76 cm (30 in) · Class 2
All models of MaxGuard (49)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885403236020), received between Sep 1, 2022 and Jan 30, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Defective Component” (3 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
- Defective Component3
- Component Missing2
- Leak/Splash1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 30, 2024Defective Component; Defective Component
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: 2636-PC - LIPID TUBING BROKE AND BLOOD BACK UP INTO THE TUBING
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18609277 ↗MalfunctionJul 11, 2023Component Missing; Component Missing
IT WAS REPORTED THAT THE BD MAXGUARD¿ EXTENSION SET EXPERIENCED A MISSING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TOP EXTENSION SET DOES NOT HAVE THIS LIGHT BLUE TIP, AND THEY ARE UNABLE TO PUSH THE THREADED PART DOWN. THEY ARE THEN UNABLE TO CONNECT TO THE BRONCHOSCOPE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17302410 ↗MalfunctionJun 29, 2023Component Missing; Component Missing
IT WAS REPORTED THAT DURING USE WITH BD MAXGUARD¿ EXTENSION SET THE BLUE END CAP WAS MISSING. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT THE TOP EXTENSION SET DOES NOT HAVE THIS LIGHT BLUE TIP, AND THEY ARE UNABLE TO PUSH THE THREADED PART DOWN. THEY ARE THEN UNABLE TO CONNECT TO THE BRONCHOSCOPE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17224304 ↗MalfunctionJun 12, 2023Defective Component; Defective Component
IT WAS REPORTED WHILE USING BD ALARIS¿ LVP 20D LOW SORB 2SS 0.2M CV THE TUBING WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE BEEN USING BD MAXGUARD EXTENSION SET REF #ME1055 FOR A LONG TIME. WE NOTICED THAT THE NEW BATCHES ARE DIFFERENT WITH THE LEUR LOCK NOT SLIDING BACK AS IT USED TO BE. PREVIOUS MODEL LOT #20045474, CURRENT LOT #23029011.
Patient problems: Insufficient Information
MAUDE report 17114391 ↗MalfunctionOct 13, 2022Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection
IT WAS REPORTED THAT THE BD ALARIS¿ LVP 20D LOW SORB 2SS 0.2M CV EXPERIENCED A LOOSE IV SET CONNECTION, AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN YOU REMOVE THE CAP THE TUBING STICKS A LITTLE AND YOU HAVE TO MOVE IT AROUND THE PART THAT CONNECTS TO THE IV BEFORE CONNECTING IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15602028 ↗MalfunctionSep 1, 2022Defective Component; Defective Component
IT WAS REPORTED WHILE USING BD ALARIS¿ LVP 20D LOW SORB 2SS 0.2M CV THE TUBING CLAMP WAS DIDN'T MOVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: ME1055, BATCH #: 22059338. IT WAS REPORTED BY THE CUSTOMER THAT THE NEW LUER LOCK CONNECTION NO LONGER SLIDES OR MOVES. VERBATIM: ME1055 THE LUER LOCK CONNECTION NO LONGER SLIDES OR MOVES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15341552 ↗
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