Bard® Ellik Bladder Evacuator 0450MRecalls & reported problems
C. R. Bard, Inc. · Bard® Ellik Bladder Evacuator · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741080807), received between May 9, 2019 and Jan 19, 2024 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Fitting Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fitting Problem1
- Inadequacy of Device Shape and/or Size1
- Material Fragmentation1
- Patient Device Interaction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
- Tissue Breakdown1
- Unspecified Tissue Injury1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJan 19, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE PATIENT EXPERIENCED TISSUE INJURY, BLADDER TEAR FROM SUCTION FORCE ON BLADDER LINING PRIOR TO THE DEVICE PLACEMENT. TISSUE INJURY COMPLICATIONS WERE DIRECTLY ATTRIBUTABLE TO THE DEVICE IN RELATION TO 0450M ELLIK BLADDER EVACUATOR REUSABLE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Tissue Breakdown; Unspecified Tissue Injury
MAUDE report 18543704 ↗MalfunctionJan 18, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT NO, THE ELLIK EVACUATOR WAS NOT SUCCESSFUL IN TISSUE AND/OR DEBRIS EVACUATION BECAUSE CLOT TOO BIG IN RELATION TO 0450M ELLIK BLADDER EVACUATOR REUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18534752 ↗MalfunctionAug 24, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE CUSTOMER ORDERED 4 ELLIK BLADDER EVACUATOR, 1 ARRIVED DAMAGED, BOX WAS NOT DAMAGED. THE PRODUCT INSIDE OF BOX ITSELF WAS DAMAGED. ALSO STATED THAT THERE WERE 2 TUBES POKING OUT A BIG ONE AND LITTLE ONE. THEY NOTICED IT WAS BROKEN OUT AT THE END OF TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17620728 ↗MalfunctionMay 9, 2019Fitting Problem
IT WAS REPORTED THAT THE METAL PIECE DID NOT FIT INTO THE LATEX TUBE.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 8596787 ↗
Other EVACUATOR, GASTRO-UROLOGY devices
- AHTO 0250070600Stryker Corporation · EVACUATOR, GASTRO-UROLOGY2 recalls44 reports
- Gyrus ACMI 190AGyrus ACMI, LLC · EVACUATOR, GASTRO-UROLOGY2 recalls0 reports
- Gyrus ACMI 190-4Gyrus ACMI, LLC · EVACUATOR, GASTRO-UROLOGY1 recall0 reports
- USA Elite 191-NRSGyrus ACMI, LLC · EVACUATOR, GASTRO-UROLOGY1 recall0 reports
- Toomey 188AGyrus ACMI, LLC · EVACUATOR, GASTRO-UROLOGY1 recall0 reports
- Toomey 188Gyrus ACMI, LLC · EVACUATOR, GASTRO-UROLOGY1 recall0 reports
- Gyrus ACMI 194-2Gyrus ACMI, LLC · EVACUATOR, GASTRO-UROLOGY1 recall0 reports
- Bard® Ellik Evacuator 000451C. R. Bard, Inc. · EVACUATOR, GASTRO-UROLOGY42 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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