Dover 1614 (UDI 10192253026139)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10192253026139), received between Apr 15, 2024 and Apr 23, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Deflate” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THE BALLOONS HAD A HOLE. THERE WAS NO PATIENT INJURY. NO FURTHER DETAILS ARE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891416 ↗
• MalfunctionOct 31, 2024Failure to Deflate; Failure to Deflate

  THE CUSTOMER REPORTED THAT UPON ATTEMPTING TO REMOVE THE CATHETER FROM THE PATIENT'S BODY, IT WAS NOT POSSIBLE TO REMOVE THE WATER FROM THE BALLOON WHICH WAS USED TO KEEP THE CATHETER IN THE BODY. PER CUSTOMER, THE CATHETER NEEDED TO BE CUT TO REMOVE FROM THE PATIENT; PERIOD OF USE: 2 WEEKS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20579611 ↗
• MalfunctionOct 17, 2024Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THE INDWELLED FOLEY CATHETER CAME OUT ON ITS OWN. THE INDWELLED LOCATION WAS URETHRA AND BLADDER. AFTER 2 DAYS OF THE OPERATION, THE CATHETER CAME OUT ON ITS OWN. UPON CONFIRMING IT, ALL THE WATER IN THE CUFF WAS ALL GONE. THERE WAS NO PATIENT HARM REPORTED, AND NO ADDITIONAL TREATMENT WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20475890 ↗
• MalfunctionJul 18, 2024Failure to Deflate; Failure to Deflate

  THE CUSTOMER REPORTED THAT WHEN ATTEMPTED TO REMOVE THE PRODUCT FROM THE PATIENT, THE STERILIZED WATER IN THE BALLOON WAS NOT RELEASED SO THAT THE BULB PART NEEDED TO BE CUT TO REMOVE FROM THE PATIENT; PERIOD OF USE: 7 DAYS. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19778473 ↗
• MalfunctionApr 15, 2024Unintended Deflation; Unintended Deflation

  CUSTOMER REPORTS: WHEN THE CUFF OF THE CATHETER WAS CHECKED TO BE USED INTRAOPERATIVELY IN ADVANCE. THE INJECTION TEST OF THE FIXATIVE WAS SUCCESSFUL, BUT THERE WAS STRONG RESISTANCE TO THE SYRINGE AT THE TIME OF THE RECOVERY TEST. WHEN INJECTED AGAIN AND RETRIEVED, THE CUFF WITHERED. A PREOPERATIVE TEST WAS PERFORMED WITH A SEPARATE CATHETER, AND THERE WAS NO PROBLEM, SO IT WAS USED FOR SURGERY. WE EXPERIENCED A SIMILAR CASE LAST WEEK, BUT WE HAVE NOT SECURED THE PRODUCT ITSELF. THE ACTUAL PRODUCT WILL BE 1EA, BUT WE WILL SEND IT. DURATION OF USE: FOUND IN PRE-USE TEST. PER ADDITIONAL INFORMATION RECEIVED ON 04/12/24, THE COMPLAINT INDICATED THAT THE CUFF WITHERED AND IT HAS BEEN CLARIFIED THAT THE BALLOON DEFLATED. A COMPLAINT WILL BE CREATED FOR THE SIMILAR CASE MENTIONED IN THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19111192 ↗
• MalfunctionApr 15, 2024Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  CUSTOMER REPORTS: THE BALLOON DID NOT DEFLATE PROPERLY TO REMOVE FROM THE PATIENT. THE CUSTOMER HAD TO CUT THE CATHETER AND INSERT A GUIDE WIRE TO DEAL WITH THE SITUATION. THE PERIOD OF USE IS UNKNOWN. THERE IS NO PATIENT INJURY. NO SAMPLE RETURN DUE TO BEING DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19108148 ↗