Dover 8887605205Recalls & reported problems
Cardinal Health, Inc. · 100% Silicone Foley Catheter,5 mL, 2-Way · Class 2
All models of Dover (90)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521016798), received between Sep 4, 2024 and Sep 4, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Obstruction of Flow” (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
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2024Obstruction of Flow; Obstruction of Flow
PER CUSTOMER, HE WAS VERY UNSATISFIED WITH THE CATHETERS HE HAD PURCHASED, HE NORMALLY USES THOSE, AND EVERYTHING WAS FINE. THIS TIME HE SAID, HE WAS HAVING AN ISSUE WITH THE FLOW, AND HE ENDED UP IN THE HOSPITAL. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE URINE FLOW WOULD NOT FLOW INTO THE BAG, IT WOULD BYPASS THE CATHETER. THERE WAS NO MEDICAL INTERVENTION OR TREATMENT REQUIRED AS THE RESULT OF THE REPORTED INCIDENT. ON (B)(6) 2024, ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE PATIENT WENT TO EMERGENCY ONLY TO HAVE THE CATHETER CHANGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20135053 ↗
Other Catheter, Retention Type, Balloon devices
- Bardex® All-Silicone Foley Catheter 165816C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON512 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175816C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON476 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI16C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON1 death383 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175812C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON234 reports
- Bardex® Lubri-Sil® All-Silicone Temp Sensing Foley Catheter 119216MC. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON167 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175814C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON153 reports
- Bardex® All-Silicone Foley Catheter 165812C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON151 reports
- SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter Tray A942216C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON2 recalls46 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.
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