MaxGuard ME2068Recalls & reported problems
BD Switzerland Sàrl · Extension Set 152 cm (60 in) · Class 2
All models of MaxGuard (49)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885403236297), received between Jul 22, 2019 and Apr 17, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Component Missing1
- Leak/Splash1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2025Material Deformation; Material Deformation
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 THE TUBING IS BENDING AND RESTRICTING FLUID FLOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21859656 ↗MalfunctionAug 20, 2024Break; Break
IT WAS REPORTED THAT BD MAXGUARD EXTENSION SET WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE CAP/CONNECTOR OF TUBING BROKE DURING A PERIPHERAL LINE CONNECTION REQUIRING REPLACEMENT WITH NEW TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20000491 ↗MalfunctionJul 15, 2021Component Missing; Component Missing
IT WAS REPORTED THAT THE 60-IN STANDARDBORE EXT SET EXPERIENCED A MISSING ROLLER CLAMP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SETS DID NOT COME WITH CLAMPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12173240 ↗MalfunctionJul 22, 2019Leak/Splash
NICU INFANT WAS RECEIVING TRANSFUSION OF PRBC. BLOOD TRANSFUSION WAS RUNNING WHEN THE TUBING WAS FOUND TO BE LEAKING. A CRACK WAS NOTED AT CONNECTION SITE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8811200 ↗
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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.
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