Dover 7000LLRecalls & reported problems
Cardinal Health 200, LLC · URINE DRAINAGE BAG WITH 400 ML URINE METER, TOP VENT, LUER-LOCK SAMPLING, DRAIN SPOUT · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521002715), received between Jul 16, 2020 and Nov 12, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER REPORTS: WHEN TAKING THE FOLEY OUT OF THE STERILE PACKAGING, THE TIP DISLODGED FROM THE TUBING.
Patient problems: No Patient Involvement
MAUDE report 10830510 ↗MalfunctionJul 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT RECENTLY ALL THE FOLEYS HAVE STARTED TO DISCONNECT WITH THE SEAL INTACT. THIS HAS HAPPENED IN THE CRITICAL CARE UNIT. SITUATIONS THAT HAVE CAUSED DISCONNECTION INCLUDE ANY PATIENT MOVEMENT IN BED OR AROUND THE UNIT. THE FOLEY WILL DISCONNECT WITHOUT EVEN REMOVING THE TAMPER EVIDENT SEAL AND LEAK ON THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10282953 ↗
Other COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER devices
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- Bard® Urine Meter with Bag 153214AC. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER107 reports
- Bard® Urine Meter with Bag 153204C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER106 reports
- SureStep™ Foley Tray System Complete Care® Add-A-Foley Catheter A399400AC. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER2 recalls0 reports
- Bard® Urinary Drainage Bag 153509C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER91 reports
- Bard® Urinary Drainage Bag 153504C. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER89 reports
- SureStep™ Foley Tray System Complete Care® Add-A-Foley Catheter A304400AC. R. Bard, Inc. · COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER1 recall12 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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