Dover 8887605163 (UDI 10884521016675)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521016675), received between Oct 23, 2020 and Jun 26, 2024 — classified as 10 malfunctions.

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

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2024Unintended Deflation; Unintended Deflation

  CUSTOMER REPORTS: THE BALLOON BROKE AT THE TIME OF INSTALLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19619273 ↗
• MalfunctionMar 22, 2024Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THE BALLOON RUPTURES 3-4 DAYS AFTER CATHETER INSERTION. PER ADDITIONAL INFORMATION RECEIVED, THERE WEREN'T ANY PIECES MISSING. THE VOLUME OF LIQUID USED TO INFLATE THE BALLOON WAS 5ML. THE LUBRICANT USED WAS THE ONE FROM THE CATHETERIZATION TRAY CODE 85-5037. THE CATHETER WAS REMOVED FROM THE PATIENT BY THE NURSE AT HOME. THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960431 ↗
• MalfunctionMar 22, 2024Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THE BALLOON RUPTURES 3-4 DAYS AFTER CATHETER INSERTION. PER ADDITIONAL INFORMATION RECEIVED, THERE WEREN'T ANY PIECES MISSING. THE VOLUME OF LIQUID USED TO INFLATE THE BALLOON WAS 5ML. THE LUBRICANT USED WAS THE ONE FROM THE CATHETERIZATION TRAY CODE 85-5037. THE CATHETER WAS REMOVED FROM THE PATIENT BY THE NURSE AT HOME. THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960377 ↗
• MalfunctionMar 20, 2024Unintended Deflation; Unintended Deflation

  CUSTOMER REPORTS: TWO OF THE CATHETERS ARE BUSTED. PER ADDITIONAL INFORMATION RECEIVED ON 03/15/24, THE CATHETER WAS INSIDE THE PATIENT FOR 6 DAYS BEFORE THE BALLOON BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18944391 ↗
• MalfunctionMar 20, 2024Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THE BALLOON OF THE FOLEY HAS RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18942363 ↗
• MalfunctionMar 20, 2024Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THE BALLOON OF THE FOLEY HAS RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18942125 ↗
• MalfunctionJul 25, 2023Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THE CATHETER'S BALLOON BROKE AND THE CATHETER FELL OUT. THE CATHETER HAD TO BE CHANGED 4 OR 5 TIMES OVER THE PERIOD OF ONE OR TWO MONTHS DUE TO THIS. THE EXACT QUANTITY AND EVENT DATES ARE NOT KNOWN. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393919 ↗
• MalfunctionFeb 10, 2022Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT AFTER INSERTING THE CATHETER INTO THE BLADDER AND INFLATING THE BALLOON ONLY TO 5ML, THE CATHETER WAS REMOVED, AND THE PATIENT WAS TAKEN TO THE OPERATION ROOM (OR) FOR A CYSTOSCOPY. A PIECE OF THE CATHETER WAS FOUND FLOATING IN THE BLADDER. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE CATHETER WAS PLACED TO INSERT A LOCAL ANESTHETIC INTO THE BLADDER AND 15 MINUTES AFTER THE INSERTION, THE CATHETER WAS REMOVED. ABOUT 20 MINUTES AFTER THE CATHETER REMOVAL, THE PATIENT WAS TAKEN TO THE OR FOR A CYSTOSCOPY. PER CUSTOMER, A CYSTOSCOPY PROCEDURE WAS AN ALREADY PLANNED PROCEDURE FOR THIS PATIENT. ONCE THE PATIENT WAS IN THE OR DURING THE PROCEDURE, WAS WHEN A PIECE OF RUPTURED CATHETER BALLOON WAS FOUND IN THE BLADDER, THEREFORE THE CUSTOMER WENT TO FIND THE CATHETER TO LOOK AT FURTHER. THE PATIENT DID NOT COMPLAIN OF ANY DISCOMFORT LIKELY DUE TO THE LOCAL ANESTHETIC THAT WAS PLACED INTO THE BLADDER. THE CUSTOMER FURTHER MENTIONED THAT THE PATIENT DID NOT REQUIRE ANY MEDICAL INTERVENTION OR FOLLOW-UP TREATMENT. THE PIECE WAS RETAINED FOR A SHORT PERIOD OF TIME. THE PATIENT IS DOING FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13506566 ↗
• MalfunctionOct 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE CONNECTOR SITE TO THE URINARY BAG IS LOOSE AND THE TUBE OF THE BAG COMES OUT OF ITS PLACE VERY OFTEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10729423 ↗
• MalfunctionOct 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE CONNECTOR SITE TO THE URINARY BAG IS LOOSE AND THE TUBE OF THE BAG COMES OUT OF ITS PLACE VERY OFTEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10729360 ↗