Dover P4P16XTSDRecalls & reported problems
Cardinal Health 200, LLC · 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 16FR (5.3 MM), 5CC, CSD · Class 2
All models of Dover (45)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Dover temperature-sensor Foley catheter is a disposable urine-collection catheter. Most reports describe parts detaching or disconnecting and urine-flow problems. There are 77 adverse event reports that name this device, including 76 malfunctions, one injury, and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 77
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 10884521066984), received between May 15, 2020 and Jun 9, 2022 — classified as 1 injury, 76 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (72 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
- Detachment of Device or Device Component72
- Infusion or Flow Problem3
- Material Separation2
Patient problems
- No Consequences Or Impact To Patient45
- No Clinical Signs, Symptoms or Conditions22
- Insufficient Information11
- No Known Impact Or Consequence To Patient3
- Urinary Retention3
Recent adverse event reports
The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 9, 2022Infusion or Flow Problem; Infusion or Flow Problem
THE CUSTOMER REPORTED THAT THEY HAD FUNCTIONAL CHALLENGES OF URINE RETENTION WITH THIS PRODUCT. ONE EXAMPLE WAS WHERE THIS ITEM WAS REMOVED AND 1,400 CC DRAINED IMMEDIATELY UPON PLACING A DIFFERENT BRAND CATHETER. SEVERAL ATTEMPTS TO GATHER INFORMATION FROM THE CUSTOMER WERE MADE. TO DATE, NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED.
Patient problems: Urinary Retention
MAUDE report 14645069 ↗MalfunctionJun 9, 2022Infusion or Flow Problem; Infusion or Flow Problem
THE CUSTOMER REPORTED THAT THEY HAD FUNCTIONAL CHALLENGES OF URINE RETENTION WITH THIS PRODUCT. SEVERAL ATTEMPTS TO GATHER INFORMATION FROM THE CUSTOMER WERE MADE. TO DATE, NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED.
Patient problems: Urinary Retention
MAUDE report 14645046 ↗MalfunctionJun 9, 2022Infusion or Flow Problem; Infusion or Flow Problem
THE CUSTOMER REPORTED THAT THEY HAD FUNCTIONAL CHALLENGES OF URINE RETENTION WITH THIS PRODUCT. SEVERAL ATTEMPTS TO GATHER INFORMATION FROM THE CUSTOMER WERE MADE. TO DATE, NO RESPONSE HAS BEEN RECEIVED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED.
Patient problems: Urinary Retention
MAUDE report 14645036 ↗MalfunctionNov 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THE FOLEY CATHETER EASILY CAME APART FROM THE DRAINAGE TUBING. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12814159 ↗MalfunctionNov 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE PATIENT WAS ADMITTED TO THE UNIT WITH A TEMPERATURE SENSOR TYPE CATHETER AND IT BECAME DISCONNECTED WHEN LIGHTLY TOUCHED. THERE WAS NO PARTICULAR LOT NUMBER IDENTIFIED. PER ADDITIONAL INFORMATION RECEIVED, THE CUSTOMER STATED THE SAMPLE HAS BEEN DISCARDED BUT THEY CAN SEND A REPRESENTATIVE SAMPLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12751286 ↗MalfunctionNov 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE PATIENT WAS ADMITTED TO THE UNIT WITH A TEMPERATURE SENSOR TYPE CATHETER AND IT BECAME DISCONNECTED WHEN LIGHTLY TOUCHED. THERE WAS NO PARTICULAR LOT NUMBER IDENTIFIED. PER ADDITIONAL INFORMATION RECEIVED, THE CUSTOMER STATED THE SAMPLE HAS BEEN DISCARDED BUT THEY CAN SEND A REPRESENTATIVE SAMPLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12751285 ↗MalfunctionNov 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE PATIENT WAS ADMITTED TO THE UNIT WITH A TEMPERATURE SENSOR TYPE CATHETER AND IT BECAME DISCONNECTED WHEN LIGHTLY TOUCHED. THERE WAS NO PARTICULAR LOT NUMBER IDENTIFIED. PER ADDITIONAL INFORMATION RECEIVED, THE CUSTOMER STATED THE SAMPLE HAS BEEN DISCARDED BUT THEY CAN SEND A REPRESENTATIVE SAMPLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12751281 ↗MalfunctionNov 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE PATIENT WAS ADMITTED TO THE UNIT WITH A TEMPERATURE SENSOR TYPE CATHETER AND IT BECAME DISCONNECTED WHEN LIGHTLY TOUCHED. THERE WAS NO PARTICULAR LOT NUMBER IDENTIFIED. PER ADDITIONAL INFORMATION RECEIVED, THE CUSTOMER STATED THE SAMPLE HAS BEEN DISCARDED BUT THEY CAN SEND A REPRESENTATIVE SAMPLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12751280 ↗MalfunctionOct 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THE CATHETER DISCONNECTED WHEN LIGHTLY TOUCHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12698920 ↗MalfunctionOct 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THE CATHETER DISCONNECTED WHEN LIGHTLY TOUCHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12698917 ↗MalfunctionOct 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE FOLEY CATHETER DISLODGED FROM THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12583715 ↗MalfunctionAug 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THE PLASTIC SEAL THAT HOLDS THE FOLEY CATHETER TO THE SAMPLE PORT IS FALLING OFF AND THE CATHETER IS DISCONNECTING WHEN THE PATIENT IS MOVED OR REPOSITIONED. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12300576 ↗MalfunctionJul 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE TUBING DISCONNECTED FROM THE CATHETER ITSELF. THERE WERE NO BALLOON ISSUES. THE CATHETER REMAINED IN THE PATIENT, BUT THE TUBING DISCONNECTED FROM THE CATHETER, SLIDING OUT WITHOUT MANIPULATING OR TEARING OF THE GREEN TAPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12249471 ↗MalfunctionJul 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE TUBING DISCONNECTED FROM THE CATHETER ITSELF. THERE WERE NO BALLOON ISSUES. THE CATHETER REMAINED IN THE PATIENT, BUT THE TUBING DISCONNECTED FROM THE CATHETER, SLIDING OUT WITHOUT MANIPULATING OR TEARING OF THE GREEN TAPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12249420 ↗MalfunctionJul 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE TUBING DISCONNECTED FROM THE CATHETER ITSELF. THERE WERE NO BALLOON ISSUES. THE CATHETER REMAINED IN THE PATIENT, BUT THE TUBING DISCONNECTED FROM THE CATHETER, SLIDING OUT WITHOUT MANIPULATING OR TEARING OF THE GREEN TAPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12249309 ↗MalfunctionJul 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE TUBING DISCONNECTED FROM THE CATHETER ITSELF. THERE WERE NO BALLOON ISSUES. THE CATHETER REMAINED IN THE PATIENT, BUT THE TUBING DISCONNECTED FROM THE CATHETER, SLIDING OUT WITHOUT MANIPULATING OR TEARING OF THE GREEN TAPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12249290 ↗MalfunctionJul 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE TUBING DISCONNECTED FROM THE CATHETER ITSELF. THERE WERE NO BALLOON ISSUES. THE CATHETER REMAINED IN THE PATIENT, BUT THE TUBING DISCONNECTED FROM THE CATHETER, SLIDING OUT WITHOUT MANIPULATING OR TEARING OF THE GREEN TAPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12249160 ↗MalfunctionJul 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER REPORTS: THE CATHETER DISCONNECTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12183935 ↗MalfunctionApr 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER REPORTS: THERE WERE TEN KNOWN INCIDENTS OF CATHETERS DISCONNECTING DURING USE. THE CASES ARE RECENT AND STARTED HAPPENING IN THE LAST 4-5 WEEKS. ADDITIONAL INFORMATION MAY NOT BE AVAILABLE BECAUSE LOT INFORMATION IS USUALLY DISCARDED. THE DEVICES ARE MOSTLY USED IN THE OR SETTING. THE STAFF HAS BEEN INSTRUCTED TO CHECK THE DEVICES BEFORE USE AND TO CONTAIN ANY THAT ARE DISCONNECTED. THE GREEN TAPE ON THE CATHETER HAS BECOME VERY LOOSE WHEREAS IT USED TO BE SO TIGHT YOU COULDN'T TWIST IT AND WOULD NEED SCISSORS TO GET IT UN DONE. NOW THE GREEN TAPE IS VERY LOOSE WHEN THEY OPEN IT AND SHE CANS SPIN IT AROUND AND MOVE IT AROUND RIGHT AWAY WHICH DOESN'T SEEM RIGHT.
Patient problems: Insufficient Information
MAUDE report 11673493 ↗MalfunctionApr 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER REPORTS: THERE WERE TEN KNOWN INCIDENTS OF CATHETERS DISCONNECTING DURING USE. THE CASES ARE RECENT AND STARTED HAPPENING IN THE LAST 4-5 WEEKS. ADDITIONAL INFORMATION MAY NOT BE AVAILABLE BECAUSE LOT INFORMATION IS USUALLY DISCARDED. THE DEVICES ARE MOSTLY USED IN THE OR SETTING. THE STAFF HAS BEEN INSTRUCTED TO CHECK THE DEVICES BEFORE USE AND TO CONTAIN ANY THAT ARE DISCONNECTED. THE GREEN TAPE ON THE CATHETER HAS BECOME VERY LOOSE WHEREAS IT USED TO BE SO TIGHT YOU COULDN'T TWIST IT AND WOULD NEED SCISSORS TO GET IT UN DONE. NOW THE GREEN TAPE IS VERY LOOSE WHEN THEY OPEN IT AND SHE CANS SPIN IT AROUND AND MOVE IT AROUND RIGHT AWAY WHICH DOESN'T SEEM RIGHT.
Patient problems: Insufficient Information
MAUDE report 11673489 ↗MalfunctionApr 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER REPORTS: THERE WERE TEN KNOWN INCIDENTS OF CATHETERS DISCONNECTING DURING USE. THE CASES ARE RECENT AND STARTED HAPPENING IN THE LAST 4-5 WEEKS. ADDITIONAL INFORMATION MAY NOT BE AVAILABLE BECAUSE LOT INFORMATION IS USUALLY DISCARDED. THE DEVICES ARE MOSTLY USED IN THE OR SETTING. THE STAFF HAS BEEN INSTRUCTED TO CHECK THE DEVICES BEFORE USE AND TO CONTAIN ANY THAT ARE DISCONNECTED. THE GREEN TAPE ON THE CATHETER HAS BECOME VERY LOOSE WHEREAS IT USED TO BE SO TIGHT YOU COULDN'T TWIST IT AND WOULD NEED SCISSORS TO GET IT UNDONE. NOW THE GREEN TAPE IS VERY LOOSE WHEN THEY OPEN IT AND SHE CANS SPIN IT AROUND AND MOVE IT AROUND RIGHT AWAY WHICH DOESN'T SEEM RIGHT.
Patient problems: Insufficient Information
MAUDE report 11673446 ↗MalfunctionApr 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER REPORTS: THERE WERE TEN KNOWN INCIDENTS OF CATHETERS DISCONNECTING DURING USE. THE CASES ARE RECENT AND STARTED HAPPENING IN THE LAST 4-5 WEEKS. ADDITIONAL INFORMATION MAY NOT BE AVAILABLE BECAUSE LOT INFORMATION IS USUALLY DISCARDED. THE DEVICES ARE MOSTLY USED IN THE OR SETTING. THE STAFF HAS BEEN INSTRUCTED TO CHECK THE DEVICES BEFORE USE AND TO CONTAIN ANY THAT ARE DISCONNECTED. THE GREEN TAPE ON THE CATHETER HAS BECOME VERY LOOSE WHEREAS IT USED TO BE SO TIGHT YOU COULDN'T TWIST IT AND WOULD NEED SCISSORS TO GET IT UN DONE. NOW THE GREEN TAPE IS VERY LOOSE WHEN THEY OPEN IT AND SHE CANS SPIN IT AROUND AND MOVE IT AROUND RIGHT AWAY WHICH DOESN'T SEEM RIGHT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11672421 ↗MalfunctionApr 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER REPORTS: THERE WERE TEN KNOWN INCIDENTS OF CATHETERS DISCONNECTING DURING USE. THE CASES ARE RECENT AND STARTED HAPPENING IN THE LAST 4-5 WEEKS. ADDITIONAL INFORMATION MAY NOT BE AVAILABLE BECAUSE LOT INFORMATION IS USUALLY DISCARDED. THE DEVICES ARE MOSTLY USED IN THE OR SETTING. THE STAFF HAS BEEN INSTRUCTED TO CHECK THE DEVICES BEFORE USE AND TO CONTAIN ANY THAT ARE DISCONNECTED. THE GREEN TAPE ON THE CATHETER HAS BECOME VERY LOOSE WHEREAS IT USED TO BE SO TIGHT YOU COULDN'T TWIST IT AND WOULD NEED SCISSORS TO GET IT UN DONE. NOW THE GREEN TAPE IS VERY LOOSE WHEN THEY OPEN IT AND SHE CANS SPIN IT AROUND AND MOVE IT AROUND RIGHT AWAY WHICH DOESN'T SEEM RIGHT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11672333 ↗MalfunctionApr 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER REPORTS: THERE WERE TEN KNOWN INCIDENTS OF CATHETERS DISCONNECTING DURING USE. THE CASES ARE RECENT AND STARTED HAPPENING IN THE LAST 4-5 WEEKS. ADDITIONAL INFORMATION MAY NOT BE AVAILABLE BECAUSE LOT INFORMATION IS USUALLY DISCARDED. THE DEVICES ARE MOSTLY USED IN THE OR SETTING. THE STAFF HAS BEEN INSTRUCTED TO CHECK THE DEVICES BEFORE USE AND TO CONTAIN ANY THAT ARE DISCONNECTED. THE GREEN TAPE ON THE CATHETER HAS BECOME VERY LOOSE WHEREAS IT USED TO BE SO TIGHT YOU COULDN'T TWIST IT AND WOULD NEED SCISSORS TO GET IT UN DONE. NOW THE GREEN TAPE IS VERY LOOSE WHEN THEY OPEN IT AND SHE CANS SPIN IT AROUND AND MOVE IT AROUND RIGHT AWAY WHICH DOESN'T SEEM RIGHT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11672294 ↗MalfunctionApr 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER REPORTS: THERE WERE TEN KNOWN INCIDENTS OF CATHETERS DISCONNECTING DURING USE. THE CASES ARE RECENT AND STARTED HAPPENING IN THE LAST 4-5 WEEKS. ADDITIONAL INFORMATION MAY NOT BE AVAILABLE BECAUSE LOT INFORMATION IS USUALLY DISCARDED. THE DEVICES ARE MOSTLY USED IN THE OR SETTING. THE STAFF HAS BEEN INSTRUCTED TO CHECK THE DEVICES BEFORE USE AND TO CONTAIN ANY THAT ARE DISCONNECTED. THE GREEN TAPE ON THE CATHETER HAS BECOME VERY LOOSE WHEREAS IT USED TO BE SO TIGHT YOU COULDN'T TWIST IT AND WOULD NEED SCISSORS TO GET IT UN DONE. NOW THE GREEN TAPE IS VERY LOOSE WHEN THEY OPEN IT AND SHE CANS SPIN IT AROUND AND MOVE IT AROUND RIGHT AWAY WHICH DOESN'T SEEM RIGHT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11672234 ↗
Other DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE devices
- Dover P4P16TSDCardinal Health 200, LLC · DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE61 reports
- Dover P4P16TSCardinal Health, Inc. · DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE10 reports
- Dover P4P16XTSCardinal Health, Inc. · DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE10 reports
- Dover P4P16SDCardinal Health 200, LLC · DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE9 reports
- Medline DYND17407LMedline Industries, Inc. · DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE2 reports
- Dover P4P18TSCardinal Health, Inc. · DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE2 reports
- Medline DYND27403SMedline Industries, Inc. · DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE1 report
- Medline DYND27403Medline Industries, Inc. · DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE1 report
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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