Dover 8887603085Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521016606), received between Sep 30, 2019 and Sep 8, 2021 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (3 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

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2021Failure to Deflate; Failure to Deflate

  THE CUSTOMER REPORTED THAT THE FOLEY CATHETER BALLOON WOULD NOT DEFLATE WHILE INSIDE OF PATIENT. AN EMERGENCY CALL TO A PHYSICIAN WAS MADE FOR ASSISTANCE TO DEFLATE THE DEVICE. ADDITIONAL INFORMATION WAS PROVIDED ON (B)(6) 2021 STATING THAT THE FOLEY DID NOT DEFLATE WHEN THE RN CIRCULATOR ATTEMPTED TO DEFLATE IT. ANOTHER RN TRIED TO DEFLATE IT BUT WAS NOT SUCCESSFUL EITHER. THE SURGEON ATTEMPTED TO HELP DEFLATE IT AND WAS NOT ABLE TO DEFLATE IT AS WELL. THE SURGEON REACHED OUT TO A UROLOGIST FROM HUNTINGTON MEMORIAL HOSPITAL TO CONSULT ABOUT THE FOLEY BALLOON UNABLE TO BE DEFLATED. THE UROLOGIST STATED THAT THE BALLOON NEEDS TO BE POPPED WITH A NEEDLE. THE SURGEON CUT THE FOLEY AND THE BALLOON AND WAS ABLE TO REMOVE IT. THE SURGERY WAS CANCELLED AFTER THE INCIDENT AND WAS RESCHEDULED. THE ISSUE DID NOT PROLONG THE PATIENT'S HOSPITAL STAY. THE PATIENT WAS DISCHARGED HOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12441192 ↗
• MalfunctionAug 10, 2021Failure to Deflate; Failure to Deflate

  THE CUSTOMER REPORTED THAT THE REGISTERED NURSE WAS UNABLE TO DEFLATE THE BALLOON TO REMOVE THE INDWELLING URINARY CATHETER. THE ATTENDING RADIOLOGIST WAS CALLED IN AND WAS ALSO UNSUCCESSFUL. UROLOGY WAS CONTACTED AND THEY WERE ALSO UNABLE TO DEFLATE THE BALLOON. UROLOGY USED AN ALTERNATE METHOD TO PUNCTURE THE BALLOON AND DEFLATE IT IN ORDER TO SAFELY REMOVE THE PATIENT'S INDWELLING URINARY CATHETER. ADDITIONAL INFORMATION PROVIDED BY THE REPORTER ON AUGUST 06, 2021 STATED THAT THE BALLOON WAS PUNCTURED USING A GUIDEWIRE AND IT RUPTURED WITH A CLEAN TEAR. THERE WAS NO PATIENT HARM. THE PATIENT WAS DISCHARGED THE SAME DAY IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304410 ↗
• InjuryAug 31, 2020Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED THAT THE CATHETER'S BALLOON WOULD NOT DEFLATE WHEN IT WAS READY TO BE REMOVED. THE PATIENT HAD TO BE TAKEN TO SURGERY TO HAVE IT REMOVED. ADDITIONAL INFORMATION PROVIDED ON 17-AUG-2020 STATED THAT THE CATHETER WAS NOT TESTED PRIOR TO INSERTION. THE INFORMATION FURTHER STATED THAT THE (B)(6) MONTH OLD PATIENT HAD A FOLEY CATHETER PASSED DURING A COMPLEX LEFT TAPERED URETERAL REIMPLANTATION ON (B)(6) 2020. THE PATIENT ARRIVED TO THE SURGEON'S OFFICE ON (B)(6) 2020 AFTER THE FAMILY WAS ATTEMPTING TO REMOVE THE FOLEY AT THE PRIMARY CARE PHYSICIAN AND THE FOLEY WOULD NOT EASILY BE REMOVED. AT THE SURGEON'S OFFICE ATTEMPTS AT TRYING TO ASPIRATE THE BALLOON WERE UNSUCCESSFUL, THEY EVEN CUT THE PORT TO SEE IF THIS WOULD RELIEVE SOME FLUID FROM THE BALLOON AND THIS WAS UNSUCCESSFUL. RISKS, BENEFITS AND OPTIONS FOR CYSTOSCOPY, POSSIBLE PERCUTANEOUS ATTEMPTS AT REMOVING THE RETAINED FOLEY WERE DISCUSSED WITH THE FAMILY AT LENGTH AND THEY AGREED TO PROCEED. THE PATIENT WAS TAKEN TO THE OPERATING ROOM, AFTER ADEQUATE GENERAL ANESTHESIA PLACED IN THE SUPINE LITHOTOMY POSITION. THE AREA WAS PREPPED AND DRAPED IN NORMAL STERILE FASHION. A VERY SMALL DENTAL WIRE WAS PASSED DOW

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 10474328 ↗
• InjuryAug 31, 2020Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED THAT THE CATHETER'S BALLOON WOULD NOT DEFLATE WHEN IT WAS READY TO BE REMOVED. THE PATIENT HAD TO BE TAKEN TO SURGERY TO HAVE IT REMOVED. ADDITIONAL INFORMATION PROVIDED ON 17-AUG-2020 STATED THAT THE FIVE YEAR OLD FEMALE WHO RECENTLY UNDERWENT RESECTION OF A LARGE LEFT MALIGNANT RENAL TUMOR WHERE AT THAT TIME SHE HAD AN EPIDURAL PLACED AS WELL AS A FOLEY CATHETER ON (B)(6) 2020. THE CATHETER WAS NOT TESTED PRIOR TO INSERTION. THE PATIENT MET CRITERIA FOR REMOVING THE FOLEY CATHETER THREE DAYS LATER. HOWEVER, BOTH THE NURSES AND THE SURGICAL RESIDENT WERE UNABLE TO DEFLATE THE BALLOON TO EXTRACT THE CATHETER. FOR THAT REASON, THE MD WAS CALLED TO THE BESIDE AND ATTEMPTED TO REMOVE THE CATHETER BY ASPIRATING AIR AND/OR FLUID FROM THE BALLOON BUT WAS UNSUCCESSFUL. NEXT, THEY CUT THE CATHETER IN HOPES THAT THIS WOULD ALLOW THE BALLOON TO DEFLATE. HOWEVER THIS TOO DID NOT WORK. ADDITIONAL ATTEMPTS AT PASSING A WIRE DOWN THE INSUFFLATION CHANNEL IN HOPES OF REMOVING ANY DEBRIS TO ALLOW THE BALLOON TO DEFLATE WERE UNSUCCESSFUL. ALSO, INJECTING THROUGH THE INFLATION PORT IN HOPES OF CLEARING OBSTRUCTION ALLOWING IT TO DRAIN WERE UNSUCCESSFUL. FOR THAT REASON, THE CHI

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 10474203 ↗
• MalfunctionMar 10, 2020Break; Break

  THE CUSTOMER REPORTED THAT THE TIP OF THE CATHETER BROKE OFF AND WAS NOT STRAIGHT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9814079 ↗
• MalfunctionMar 10, 2020Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THAT THE BALLOON POPPED, NOT SMOOTH, AND HAS A SLIT IN THE BALLOON AREA. THERE WAS NO INJURY REPORTED TO THE PATIENT INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9813959 ↗
• MalfunctionSep 30, 2019Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED THAT WHEN THE REGISTERED NURSE (RN ) WAS REMOVING THE FOLEY CATHETER IT BECAME STUCK. THE BALLOON CONTAINED 5MLS AND THE RN REMOVED 5MLS, BUT IT SEEMED LIKE THE BALLOON DID NOT DEFLATE ALL THE WAY AND WOULD NOT COME OUT. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9134401 ↗