Dover 6162MFRecalls & reported problems
Cardinal Health, Inc. · Latex Foley Catheter Tray,Closed System · Class 2
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10884521050587), received between Jul 2, 2019 and Feb 3, 2022 — classified as 1 injury, 17 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (7 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
- Deflation Problem7
- Detachment of Device or Device Component4
- Difficult to Remove2
- Material Rupture2
- Failure to Deflate1
- Material Fragmentation1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Consequences Or Impact To Patient6
- No Patient Involvement2
- No Code Available1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2022Deflation Problem; Deflation Problem
THE CUSTOMER REPORTED THAT AFTER THE BALLOON WAS INFLATED FOR TESTING, IT DID NOT DEFLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13446500 ↗MalfunctionDec 21, 2021Failure to Deflate; Failure to Deflate
THE CUSTOMER REPORTED THE BALLOON WAS TESTED BY INJECTING WATER INTO THE BALLOON VIA SYRINGE BEFORE THE CATHETER WAS INSERTED INTO THE PATIENT. THE WATER WOULDN'T RETURN TO THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13052112 ↗MalfunctionDec 3, 2021Deflation Problem; Deflation Problem
THE CUSTOMER REPORTED THAT UNABLE TO RETRIEVE WATER FROM THE BALLOON EASILY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12923684 ↗MalfunctionNov 23, 2021Obstruction of Flow; Obstruction of Flow
THE CUSTOMER REPORTED THE TUBE OF THE URINARY DRAINAGE BAG WAS KINKING AND IT WOULDN'T LET URINE FLOW THROUGH. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12865390 ↗MalfunctionOct 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT DUE TO AN UNKNOWN FACTOR, THE CATHETER WAS EXPOSED TO FORCE WHICH CAUSED IT TO BE SEPARATED AT THE OUTSIDE OF THE PATIENT¿S BODY. THE DURATION OF USE WAS 10 DAYS. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12713082 ↗MalfunctionOct 12, 2021Material Rupture; Material Rupture
CUSTOMER REPORTS: INDWELLING BALLOON BURST. NO PATIENT HARM. THE DURATION OF USE IS UNKNOWN. ADDITIONAL INFORMATION WAS PROVIDED UPON THE VERIFICATION PERFORMED AT COVIDIEN (B)(4), THE BALLOON DID BURST WITH FRAGMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12618591 ↗MalfunctionOct 5, 2021Deflation Problem; Deflation Problem
THE CUSTOMER REPORTED THAT WHEN CHECKING THE BALLOON BEFORE USE BY INJECTING WATER, IT DIDN¿T DRAIN. THE ISSUE WAS DISCOVERED DURING PREPARATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12577705 ↗MalfunctionSep 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT DURING USE, THE CATHETER WAS DETACHED FROM THE URINARY DRAINAGE BAG. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12410709 ↗MalfunctionJul 6, 2021Material Rupture; Material Rupture
THE CUSTOMER REPORTED AN ACCIDENTAL BALLOON REMOVAL OCCURRED AND THEY NOTICED THE BALLOON HAD RUPTURED INTO FRAGMENTS. THE DRUGS USED WERE BENZALKONIUM CHLORIDE SOLUTION AND WHAT WAS PACKED IN THE PACKAGE ONLY. DURATION OF USE WAS ABOUT 2 DAYS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12123759 ↗MalfunctionNov 12, 2020Difficult to Remove; Difficult to Remove
CUSTOMER REPORTS: DURING TESTING OF THE BALLOON, AFTER INDWELLING THE CATHETER, THE STERILE WATER IN THE BALLOON WAS UNABLE TO BE PULLED OUT. SEVERAL ATTEMPTS WERE MADE HOWEVER, THE WATER WAS UNABLE TO BE REMOVED FROM THE BALLOON.
Patient problems: No Patient Involvement
MAUDE report 10831197 ↗MalfunctionOct 28, 2020Deflation Problem; Deflation Problem
THE CUSTOMER REPORTED THE BALLOON WAS UNABLE TO BE REMOVED. A NEEDLE WAS INSERTED INTO THE BALLOON LUMEN AND IT WAS ABLE TO BE REMOVED. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10747827 ↗MalfunctionOct 15, 2020Deflation Problem; Deflation Problem
THE CUSTOMER REPORTED WHEN PUTTING WATER INTO THE BALLOON, THE WATER WAS DIFFICULT TO GET IN AND OUT AND THE BALLOON WOULD NOT DEFLATE.
Patient problems: No Patient Involvement
MAUDE report 10684725 ↗MalfunctionMay 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE CATHETER DETACHED FROM THE BAG DURING USE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10099065 ↗MalfunctionApr 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE CATHETER DETACHED FROM THE TUBE AT THE CONNECTING PART.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10005910 ↗MalfunctionMar 24, 2020Deflation Problem; Deflation Problem
THE CUSTOMER REPORTED THAT DURING THE BALLOON INSPECTION, THE WATER COULD NOT BE REMOVED FROM THE BALLOON.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9874556 ↗InjuryFeb 27, 2020Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A HERNIA SURGERY ON (B)(6) 2020. AT 12 PM, THE CATHETER WAS INDWELLED AND THE BALLOON WAS CHECKED AND PERFORMED WITHOUT PROBLEMS. AT 9 PM, IT WAS FOUND THAT THE CATHETER HAD COME OUT ON ITS OWN. UPON VISUAL INSPECTION OF THE CATHETER TIP, THE BALLOON SEEMED TO BE PARTIALLY MISSING AND IT WAS ASSUMED THERE MIGHT BE FRAGMENTS OF THE BALLOON INSIDE THE PATIENT SO THE DOCTOR CONFIRMED IT WITH A CYSTOSCOPE. THE RESULT WAS NO PIECE OF BALLOON/CATHETER WAS LEFT INSIDE THE PATIENT. NO PATIENT HARM WAS REPORTED.
Patient problems: No Code Available
MAUDE report 9764805 ↗MalfunctionDec 3, 2019Deflation Problem; Deflation Problem
THE CUSTOMER REPORTED THAT THEY TRIED TO REMOVE THE CATHETER 10 HOURS AFTER INDWELLING IT, HOWEVER, THE WATER WAS UNABLE TO COME OUT OF THE BALLOON. NO PATIENT HARM WAS REPORTED. IT IS NOT KNOWN HOW THE CATHETER WAS REMOVED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9405724 ↗MalfunctionJul 2, 2019Difficult to Remove; Difficult to Remove
THE CUSTOMER REPORTED THAT ALL THE WATER WAS NOT ABLE TO BE PULLED FROM THE BALLOON WHEN REMOVING THE CATHETER. HOWEVER, THE CATHETER WAS ABLE TO BE REMOVED FROM THE PATIENT PULLING AS USUAL, THERE WAS NO INJURY AND OR HARM TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8755774 ↗
Other Urinary Drainage Collection Kit devices
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- Dover 6155MFCardinal Health, Inc. · Urinary Drainage Collection Kit4 reports
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- Dover 7016MFCardinal Health, Inc. · Urinary Drainage Collection Kit2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.