Dover 1619 (UDI 10192253026153)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10192253026153), received between Dec 6, 2024 and Aug 28, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Unintended Deflation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50503253 ↗
• MalfunctionDec 6, 2024Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED THAT THEY TOOK OUT THE PRODUCT FROM THE FRESHLY OPENED PACKAGE, AND CHECKED THE PRODUCT IF THE BALLOON WOULD INFLATE BY INJECTING THE 10 ML OF STERILIZED WATER USING A SYRINGE. THE CUSTOMER WAS ABLE TO INJECT THE WATER, AND THE BALLOON INFLATED WITHOUT PROBLEMS. HOWEVER, WHEN PULLING THE SYRINGE TO REMOVE THE WATER, IT HAS ONLY REMOVED ABOUT 5 ML, AND THE BALLOON DID NOT DEFLATE. BY REPEATING THE SYRINGE PULLING PROCESS A FEW TIMES, THE WATER WAS REMOVED EVENTUALLY. THERE WAS NO PATIENT USE; PERIOD OF USE: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860349 ↗