Dover 1621Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10192253026160), received between Mar 21, 2024 and Aug 26, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Unintended Deflation” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT AFTER 1 DAY SINCE DWELLING THE BALLOON, IT WAS COMING OFF. UPON CHECKING, THE BALLOON WAS BROKEN. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893947 ↗
• MalfunctionSep 10, 2024Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT A LEAK WAS OBSERVED UPON INFLATING THE BALLOON PRIOR TO INDWELLING TO THE PATIENT. THERE WAS NO PATIENT USE. THE ISSUE WAS DISCOVERED DURING PREPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185239 ↗
• MalfunctionMar 21, 2024Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THE BALLOON CAME OUT ON THE DAY OF THE CATHETER PLACEMENT. THE SAME EVENT OCCURRED TWO TIMES ON THE SAME PATIENT. PRIOR TO INDWELLING, IT WAS CONFIRMED THAT THE BALLOON HAD NO LEAKAGE WHEN WATER WAS POURED, SO IT HAS BEEN POINTED OUT THAT THE ISSUE CAN BE DERIVED BY THE PATIENT; PERIOD OF USE: LESS THAN A DAY. THERE WAS NO HARM TO THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18951586 ↗