MaxGuard ME5301Recalls & reported problems
BD Switzerland Sàrl · Pressure rated extension Set, 19 cm (7.5 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 10885403230165), received between Apr 24, 2023 and May 15, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (4 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
Device problems
- Complete Blockage4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED THAT 3 BD MAXGUARD¿ PRESSURE-RATED EXTENSION SETS WOULD NOT FLUSH DUE TO BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE DEPARTMENT THAT RAISED THE CONCERN STATED THEY TRIED ABOUT 3 EACH WITH THE SAME LOT NUMBER. EACH ONE WOULD NOT FLUSH PROPERLY AND WAS GETTING CLOGGED. THEY SWITCHED TO A DIFFERENT LOT # AND HAS NOT EXPERIENCED ANY ISSUES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16931390 ↗MalfunctionMay 15, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED THAT 3 BD MAXGUARD¿ PRESSURE-RATED EXTENSION SETS WOULD NOT FLUSH DUE TO BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE DEPARTMENT THAT RAISED THE CONCERN STATED THEY TRIED ABOUT 3 EACH WITH THE SAME LOT NUMBER. EACH ONE WOULD NOT FLUSH PROPERLY AND WAS GETTING CLOGGED. THEY SWITCHED TO A DIFFERENT LOT # AND HAS NOT EXPERIENCED ANY ISSUES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16931353 ↗MalfunctionMay 15, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED THAT 3 BD MAXGUARD¿ PRESSURE-RATED EXTENSION SETS WOULD NOT FLUSH DUE TO BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE DEPARTMENT THAT RAISED THE CONCERN STATED THEY TRIED ABOUT 3 EACH WITH THE SAME LOT NUMBER. EACH ONE WOULD NOT FLUSH PROPERLY AND WAS GETTING CLOGGED. THEY SWITCHED TO A DIFFERENT LOT # AND HAS NOT EXPERIENCED ANY ISSUES."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16931352 ↗MalfunctionApr 24, 2023Complete Blockage; Complete Blockage
IT WAS REPORTED THAT 3 OF THE BD STANDARDBORE IV EXTENSION SET WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE DEPARTMENT THAT RAISED THE CONCERN STATED THEY TRIED ABOUT 3 EACH WITH THE SAME LOT NUMBER. EACH ONE WOULD NOT FLUSH PROPERLY AND WAS GETTING CLOGGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16804330 ↗
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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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