Dover 6148ICLLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521009165), received between May 8, 2023 and May 8, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Unintended Deflation” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 8, 2023Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THE FOLEY BALLOON BROKE IN THE MORNING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16891296 ↗
• MalfunctionMay 8, 2023Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THEY HAD A PATIENT COME INTO THE EMERGENCY ROOM WITH URINARY RETENTION THAT REQUIRED FOLEY CATHETER PLACEMENT. THE CATHETER WAS INSERTED WITHOUT DIFFICULTY. SHORTLY AFTER DISCHARGE THE PATIENT RETURNED AS HIS FOLEY FELL OUT WHEN HE SAT DOWN. HE BROUGHT THE FOLEY IN AND THEY TESTED IT WITH 10ML OF SALINE PER MANUFACTURE RECOMMENDATION AND THE SALINE LEAKED OUT WHERE BALLOON IS LOCATED, IT NEVER INFLATED. THE PATIENT WAS DISCHARGED AGAIN, WENT HOME, SAT DOWN AND THE CATHETER FELL OUT AGAIN. HE CALLED AT THIS TIME AND LET THEM KNOW THE BALLOON WAS DEFLATED. THE PATIENT WENT IN FOR A THIRD TIME BUT DID NOT BRING THE CATHETER IN WITH HIM SO THEY WERE UNABLE TO TEST IT. THEY CHOSE TO PUT A DIFFERENT STYLE OF FOLEY IN AT THAT TIME (NONE SILVER COATED SILICONE, THE BLUE ONES).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16890751 ↗