Dover 8887630203Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521011953), received between Aug 30, 2023 and Aug 30, 2023 — 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. How this data works · Data updated Oct 13, 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 30, 2023Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THEY THOUGHT THEIR RESIDENT WAS MAYBE PULLING THE CATHETER OUT BUT THEY WITNESSED THE BALLOON WAS DEFLATING ON ITS OWN AND THEY DID NOT SEE ANY PIN HOLES. THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17650586 ↗
• MalfunctionAug 30, 2023Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THE NURSE TESTED 2 BALLOONS, AND WITNESSED THAT THE BALLOON WAS DEFLATING ON ITS OWN AND THEY DID NOT SEE ANY PIN HOLES. THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17650565 ↗
• MalfunctionAug 30, 2023Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THEY WITNESSED THE BALLOON WAS DEFLATING ON ITS OWN AND THEY DID NOT SEE ANY PIN HOLES. THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17650564 ↗