Dover 8887605148 (UDI 10884521016668)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521016668), received between May 20, 2021 and May 21, 2025 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Unintended Deflation” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THE FOLEY CATHETER BALLOON HAS POPPED INSIDE THE PATIENT (WHILE FOLEY IN SITU) 3 TIMES IN A ROW. THE TWO OCCURRENCES HAPPENED WITHIN 36 HOURS. THE PATIENT COULD FEEL THE BALLOON POP AND THEN FOLEY FALLS OUT. PER CUSTOMER, ON THE PACKING FOR THIS PRODUCT IT STATES 5ML 2 WAY RETENTION; HOWEVER, ON THE FOLEY CATHETER ITSELF IT READS "INFLATE W/10MLS' ON THE BALLOON PORT. THE LAST 3 TIMES WHEN THE BALLOON POPPED, THE NURSES HAD INSTILLED 10 MLS INTO THE BALLOON AND THIS TIME AFTER REVIEWING THE PACKAGING FURTHER THEY INSTILLED 5 MLS INTO THE BALLOON. HOWEVER, THEY WERE UNABLE TO SEE IF THE LAST CATHETER BALLOON WOULD POP BECAUSE THE PHYSICIAN ORDERED THE FOLEY OUT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22065049 ↗
• InjurySep 12, 2024Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THE CATHETER BALLOON WAS BURST INSIDE THE PATIENT AND A CHUNK OF THE SILICONE REMAINED IN THE PATIENT¿S BLADDER. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE FOLEY WAS INSERTED ON (B)(6) 2024, AT 18:28 AND THE TEAM NOTICED FOLEY HAD COME OUT AT 19:15. THE BALLOON WAS NOT INTACT. PER CUSTOMER, CYSTOSCOPY PROCEDURE WAS PERFORMED TO REMOVE THE FRAGMENTS IN THE PATIENT¿S BLADDER. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2024.

  Patient problems: Foreign Body In Patient

  MAUDE report 20202573 ↗
• MalfunctionSep 5, 2024Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THEY HAD INSERTED 14 FR FOLEY INTO THE PATIENT AS PER FACILITY POLICY. THE BALLOON WAS INFLATED WITH 10 ML OF SALINE AS PER INSTRUCTION ON FOLEY CATHETER (CATHETER HUB STATES "INFLATE WITH 10ML"). PER CUSTOMER, SEVERAL MINUTES LATER WHEN PREPARING TO FLIP THE PATIENT PRONE, THE FOLEY SLIPPED OUT OF THE PATIENT, AND THE BALLOON WAS OBSERVED TO BE BROKE. A NEW 14 FR FOLEY WAS INSERTED AND NO ISSUES OBSERVED, AND CLEAR URINE WAS RETURNED. THE INCIDENT HAPPENED IN OR NEURO (OR D). THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20148595 ↗
• MalfunctionAug 28, 2024Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT AFTER THE PROCEDURE, THE CATHETER BALLOON POPPED WITHIN PATIENT BLADDER. THE PATIENT REQUIRED UROLOGY FOLLOW-UP AND A NEW CATHETER HAS BEEN PLACED (ADDITIONAL PROCEDURAL TIME AND COSTS). ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE BALLOON BROKE HOWEVER THERE WAS A QUERY IF ALL THE PIECES WERE DISPELLED. PER CUSTOMER, THE PATIENT FELT A POP. A UROLOGY CONSULTATION WITH AN ULTRASOUND AND CT CONFIRMED THAT NO RETAINED PIECES WAS LEFT INSIDE THE PATIENT. A NEW FOLEY WAS PLACED WITHOUT ANY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20091274 ↗
• MalfunctionMar 29, 2024Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THE FOLEY WAS PLACED FOR SPINAL HARDWARE REMOVAL, BACLOFEN CATHETER REMOVAL, AND PICC LINE PLACEMENT PROCEDURE WITH LONG ANTICIPATED DURATION. THE 14 FRENCH FOLEY WAS PLACED EASILY, URINE RETURNED, 10 ML OF STERILE WATER WAS INSTILLED INTO BALLOON (VERIFIED THAT THIS WAS APPROPRIATE AMOUNT), AND THE FOLEY WAS CONNECTED TO DRAINAGE BAG AND WORKING APPROPRIATELY. MID CASE, THE ANESTHESIOLOGIST NOTICED URINE HAD STOPPED FLOWING INTO THE COLLECTION BAG. THE FOLEY HAD NOT BEEN MOVED, TOUCHED, OR MANIPULATED. AFTER FLIPPING PATIENT SUPINE, IT WAS NOTICED THAT THE BALLOON ON THE FOLEY HAD A RUPTURED AND THE FOLEY HAD SLIPPED OUT WHILE THE PATIENT WAS SUPINE. A NEW FOLEY WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19002972 ↗
• MalfunctionMar 23, 2024Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT WHEN BLOCKING THE BLADDER CATHETER WITH 10ML NACL, THE CATHETER¿S BALLOON WAS BURST AND THE CATHETER COULD NOT BE BLOCKED, A NEW CATHETER HAD TO BE UNPACKED AND INSERTED. THIS INCIDENT HAPPENED FOR THE 2ND TIME IN THE SAME BATCH WITHIN A WEEK. THE FAILED BLOCKAGE OF THE CATHETER WAS NOTICED IMMEDIATELY, AS THE CATHETER FELL OUT AGAIN, THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18965578 ↗
• MalfunctionMar 20, 2024Material Rupture; Material Rupture

  CUSTOMER REPORTS: THERE IS AN ISSUE WITH PRODUCT #8887605148 PURCHASED ON PO# (B)(4) FOR OUR STE-FOY LOCATION ACCOUNT # (B)(6). OUR CLIENT HAS BEEN USING FOLEY¿S FOR A LONG TIME AND THEY ARE ALWAYS INSTALLED BY THE CLSC AND EVERY TIME THE CLSC INSTALLED THE FOLEY¿S FROM THAT BOX, THE FOLEY BALLOON WOULD BE POPPED BY THE NEXT DAY. THEY WENT THROUGH 4 FOLEYS BEFORE HAVING TO SWITCH TO A DIFFERENT BRAND. PER ADDITIONAL INFORMATION PROVIDED ON 2/12/2024, THE FOUR INSTANCES OR THE BALLOON BURST OCCURRED WITH THE SAME PATIENT IN LESS THAN 24 HOURS. THE BALLOON WAS INFLATED WITH 5ML OF LIQUID AND RUPTURED WITH NO FRAGMENTED PIECES. THE LUBRICANT THAT WAS USED WAS THE MRX85-3001.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18943833 ↗
• MalfunctionMar 15, 2024Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THE A FEMALE PATIENT RECEIVED A CATHETER, WHICH WAS ALSO BLOCKED WITH AQUA DEST. BUT AFTER A SHORT TIME, THE CATHETER FELL OUT. IT WAS THEN NOTICED THAT THE BALLOON HAD BURST. THIS HAPPENED 3 TIMES IN A ROW. THE CUSTOMER FURTHER STATED THAT THERE WAS ONLY ONE PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THEY HAD TO USE FOUR DIFFERENT CATHETERS UNTIL THEY HAD ONE WHERE THE BALLOON WASN'T BROKEN. PER CUSTOMER, THEY CAN¿T TELL IF THEY WERE ALL FROM THE SAME BATCH. THEY ONLY HAD THE PACKAGING FOR TWO OF THEM AND THEY WERE THE SAME BATCH NUMBER. THE CUSTOMER FURTHER STATED THAT AFTER CATHETERIZATION OF THE 4TH CATHETER, IT WAS HELD FOR 2 DAYS UNTIL THE PATIENT DIED. THE PATIENT'S DEATH HAD NOTHING TO DO WITH THE DEFECTIVE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18916872 ↗
• MalfunctionFeb 16, 2024Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THE FOLEY CATHETER WAS FOUND IN PATIENT PROTECTION WITHOUT BALLOON. THE REMAINING PROBE WAS FOUND IN THE REMOVING GUARD, WITHOUT A BALLOON AND PIERCED AT THE BALLOON. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE BALLOON WAS DEFLATED. THE CUSTOMER FURTHER STATED THAT REMOVING GUARD MEANS LAYER FOR AN ADULT. PER CUSTOMER, THE PATIENT HAD A FOLEY CATHETER, BUT HE WAS WEARING A DIAPER, WHEN THE NURSE REMOVED THE DIAPER THE FOLEY CATHETER HAD FALLEN INTO THE DIAPER, THE BALLOON WAS DISAPPEARED. THE CUSTOMER DOESN¿T KNOW THEY CAN SEE THE BALLOON. THERE WAS NO FRAGMENTED PIECE WAS LEFT INSIDE THE PATIENT AND THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18720612 ↗
• MalfunctionOct 6, 2021No Flow; No Flow

  THE CUSTOMER REPORTED THAT DIFFICULTY WAS OBSERVED IN THE EXIT OF URINE FROM THE BLADDER. THE CUSTOMER FURTHER STATED THAT THE CIRCUIT WAS VERIFIED, THE APPARENT FAULT WAS NOT FOUND AND THE INSTALLATION PROCESS WAS CARRIED OUT ACCORDING TO PROTOCOL. THE MIDWIVES REPORT THAT THEY HAD TO MOBILIZE THE CIRCUIT SO THAT THE URINE DESCENDED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER STATED THAT THE CATHETER HAD TO BE MOVED/SHOOK/REPOSITIONED FOR URINE TO START FLOWING FROM THE BLADDER THROUGH THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12583042 ↗
• MalfunctionOct 6, 2021No Flow; No Flow

  THE CUSTOMER REPORTED THAT DIFFICULTY WAS OBSERVED IN THE EXIT OF URINE FROM THE BLADDER. THE CUSTOMER FURTHER STATED THAT THE CIRCUIT WAS VERIFIED, THE APPARENT FAULT WAS NOT FOUND AND THE INSTALLATION PROCESS WAS CARRIED OUT ACCORDING TO PROTOCOL. THE MIDWIVES REPORT THAT THEY HAD TO MOBILIZE THE CIRCUIT SO THAT THE URINE DESCENDED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER STATED THAT THE CATHETER HAD TO BE MOVED/SHOOK/REPOSITIONED FOR URINE TO START FLOWING FROM THE BLADDER THROUGH THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12583031 ↗
• MalfunctionOct 6, 2021No Flow; No Flow

  THE CUSTOMER REPORTED THAT DIFFICULTY WAS OBSERVED IN THE EXIT OF URINE FROM THE BLADDER. THE CUSTOMER FURTHER STATED THAT THE CIRCUIT WAS VERIFIED, THE APPARENT FAULT WAS NOT FOUND AND THE INSTALLATION PROCESS WAS CARRIED OUT ACCORDING TO PROTOCOL. THE MIDWIVES REPORT THAT THEY HAD TO MOBILIZE THE CIRCUIT SO THAT THE URINE DESCENDED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER STATED THAT THE CATHETER HAD TO BE MOVED/SHOOK/REPOSITIONED FOR URINE TO START FLOWING FROM THE BLADDER THROUGH THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12583019 ↗
• MalfunctionMay 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE END USER REPORTED THAT 4 UNITS WERE DAMAGED. THE BALLOONS WERE CRACKED AND THE CATHETER WAS DETACHED. THERE IS ALSO A CONCERN THAT THE CATHETER MAY HAVE BEEN USED BECAUSE THE BALLOON WAS FILLED WITH 10 ML DISTILLED WATER. THE CATHETER WAS NOT DAMAGED DURING THE INSERTION. THE DEVICES WERE INSTALLED PROPERLY AND ACCORDING TO THE SHELF LIFE DATE IT IS NOT EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 11860091 ↗