Dover P4P16CSDKRecalls & reported problems
Cardinal Health, Inc. · 100% Silicone Urine Meter Foley Tray with Coude Tip,16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 400 mL Urine Meter with 2000 mL Drainage Bag with Adhesive Catheter Securement · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521174061), received between May 28, 2020 and Jun 27, 2023 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Dec 4, 2023Open, Classified
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Z-1048-2024 · Root cause: Nonconforming Material/Component · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component4
- Material Rupture1
- Material Separation1
Patient problems
- No Patient Involvement4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2023Material Rupture; Material Rupture
CUSTOMER REPORTS: THE FOLEY BALLOON BURST. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6)2023, THE BALLOON BURSTS OCCURRED WITH THE SAME PATIENT. FIVE HOURS AFTER THE 4TH FOLEY WAS REPLACED, THE BALLOON POPPED AGAIN. PATIENT WENT TO AKRON BATH THEY PUT IN AN 18F FOLEY WHICH POPPED AN HOUR LATER. SHE THEN RETURNED TO MEDINA. UROLOGY THOUGHT IT COULD BE RELATED TO A BLADDER STONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17212678 ↗InjuryNov 16, 2021Material Separation; Material Separation
THE CUSTOMER REPORTED THE TIP OF THE CATHETER WAS TORN OFF WHEN THE CATHETER WAS REMOVED FROM THE PATIENT. THEY STATED THAT UPON INSERTION THERE WAS MORE RESISTANCE THAN NORMAL BUT DID NOT CHECK THE CATHETER TIP. THEY PERFORMED AN MRI AND CAT SCAN TO ENSURE THAT THE CATHETER WAS NO LONGER IN THE PATIENT. ADDITIONAL INFORMATION PROVIDED BY THE INITIAL REPORTER STATED THAT THE CATHETER WAS NOT TESTED PRIOR TO USE. THE CATHETER WAS INSERTED AND REMOVED ON THE SAME DAY. AT THE END OF THE CASE, ANESTHESIA REPORTED FAIRLY MINIMAL URINE OUTPUT SEEN IN THE FOLEY. DRAPES DOWN, RN REPORTED TH AT THE CATHETER WAS STILL SECURED TO THE RIGHT THIGH HOWEVER UPON PULLING THE CATHETER PORTION, IT APPEARED TO PULL AWAY EASILY AND REVEALED A FOLEY CATHETER TIP THAT APPEARED WITH A TEAR/MISSING PATTERN AT THE TIP. CT SCAN POST-OP WAS COMPLETED AND READ NEGATIVE. CYSTOSCOPE WAS PERFORMED AND THE MISSING TIP WAS NOT LOCATED. THE TIP WAS NOT FOUND AFTER A THOROUGH SEARCH. NO FURTHER INTERVENTION WAS SCHEDULED OR REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12821314 ↗MalfunctionMay 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE FOLEY CATHETER WAS DISCONNECTED EASILY. THE GREEN SEAL REMAINED INTACT BUT THE FOLEY WAS DISCONNECTING WHERE IT CONNECTS TO THE TUBING BY THE SAMPLE PORT. THE PRODUCT WAS NOT USED ON A PATIENT.
Patient problems: No Patient Involvement
MAUDE report 10098402 ↗MalfunctionMay 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE FOLEY CATHETER WAS DISCONNECTED EASILY. THE GREEN SEAL REMAINED INTACT BUT THE FOLEY WAS DISCONNECTING WHERE IT CONNECTS TO THE TUBING BY THE SAMPLE PORT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 10098375 ↗MalfunctionMay 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE FOLEY CATHETER WAS DISCONNECTED EASILY. THE GREEN SEAL REMAINED INTACT BUT THE FOLEY WAS DISCONNECTING WHERE IT CONNECTS TO THE TUBING BY THE SAMPLE PORT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 10098311 ↗MalfunctionMay 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE FOLEY CATHETER WAS DISCONNECTED EASILY. THE GREEN SEAL REMAINED INTACT BUT THE FOLEY WAS DISCONNECTING WHERE IT CONNECTS TO THE TUBING BY THE SAMPLE PORT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 10098290 ↗
Other Urinary Drainage Collection Kit devices
- Dover P4P14TSDCardinal Health, Inc. · Urinary Drainage Collection Kit1 recall12 reports
- Dover 6153Cardinal Health 200, LLC · Urinary Drainage Collection Kit1 recall0 reports
- Dover 6154Cardinal Health 200, LLC · Urinary Drainage Collection Kit1 recall0 reports
- Dover P4P18CSDKCardinal Health, Inc. · Urinary Drainage Collection Kit1 recall0 reports
- Dover 6162MFCardinal Health, Inc. · Urinary Drainage Collection Kit18 reports
- Dover 6155MFCardinal Health, Inc. · Urinary Drainage Collection Kit4 reports
- Dover 6156MFCardinal Health, Inc. · Urinary drainage collection kit3 reports
- Dover 7016MFCardinal Health, Inc. · Urinary Drainage Collection Kit2 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 · each recall links to the FDA recall notice
- 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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