Dover 1614 (UDI 10884521016224)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521016224), received between Jan 15, 2020 and Nov 3, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2023Failure to Deflate; Failure to Deflate

  THE CUSTOMER REPORTED WHEN THEY ATTEMPTED TO INFLATE THE BALLOON, ONLY 6CC'S WERE ABLE TO BE INJECTED, SO THE INFLATION WAS INCOMPLETE. THE USER ATTEMPTED TO REMOVE THE WATER, BUT WAS NOT ABLE TO. THE USER REMOVED THE PRODUCT BY CUTTING IT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18065914 ↗
• MalfunctionOct 9, 2023Difficult to Remove; Difficult to Remove

  CUSTOMER REPORTS: THE PRODUCT WAS USED FOR A GYNECOLOGIC OPERATION. WHEN ATTEMPTING TO REMOVE THE DEVICE FROM THE PATIENT¿S BODY AFTER THE OPERATION, A SYRINGE WAS USED, HOWEVER, IT FAILED TO DRAIN THE STERILIZED WATER FROM THE BALLOON LEFT IN THE BODY. THE INFLATION LUMEN WAS CUT OFF, HOWEVER, IT ALSO DID NOT RESOLVE THE ISSUE. THE PRODUCT WAS FINALLY REMOVED FROM THE PATIENT'S BODY WITH THE USE OF A WIRE. IT TOOK 45 MINUTES FOR THIS WHOLE REMOVAL PROCEDURE AFTER THE OPERATION ITSELF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17898552 ↗
• MalfunctionApr 12, 2023Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED BEFORE USE, WHEN THE BALLOON WAS INSPECTED, THE WATER LEAKED. NO PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16723845 ↗
• MalfunctionJul 25, 2022Failure to Deflate; Failure to Deflate

  THE CUSTOMER REPORTED THAT THE BALLOON WOULD NOT DEFLATE. IT WAS ONLY PLACED LESS THAN 2 HOURS BEFORE THE ATTEMPTED REMOVAL. ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER STATED THAT THE PA FINALLY PLACED A GUIDEWIRE INTO THE BALLOON CHANNEL AND DEFLATED IT THEREFORE NO INVASIVE PROCEDURE NEEDED TO DEFLATE THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15099073 ↗
• MalfunctionNov 24, 2020Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED THAT WHEN ATTEMPTED TO REMOVE THE CATHETER, THE BALLOON WAS UNABLE TO DEFLATE. THEREFORE, CUTTING THE CATHETER WAS REPEATED, AS THE RESULT THE BALLOON DEFLATED, AND THE CATHETER WAS ABLE TO BE REMOVED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10896167 ↗
• MalfunctionJan 15, 2020Difficult to Remove; Difficult to Remove

  THE CUSTOMER REPORTED THAT THE BALLOON WAS NOT ABLE TO DEFLATE AND THE CATHETER HAD TO BE CUT IN ORDER TO REMOVE IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9593312 ↗