Dover 605189ICRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521026469), received between Dec 16, 2020 and Jan 14, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2021Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THAT THE CATHETER FAILED APPROXIMATELY 2 WEEKS AFTER INSERTION. THEY SPECULATE THERE WAS AN ACCUMULATION OF RESIDUE RESULTING IN BLOCKAGE AND POSSIBLE INFECTION. THE RESIDENT HAD A FULL BLADDER AND PAIN AND WHEN A NEW FOLEY CATHETER WAS INSERTED, THE PATIENT HAD UPWARDS OF 900CC OF URINE IN HER BLADDER. ADDITIONALLY, THE SILVER LINED CATHETERS ARE DIFFICULT TO FLUSH WHEN THEY BLOCK.

  Patient problems: Pain; Urinary Retention

  MAUDE report 11171472 ↗
• MalfunctionJan 14, 2021Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THAT THE CATHETER FAILED APPROXIMATELY 2 WEEKS AFTER INSERTION. THEY SPECULATE THERE WAS AN ACCUMULATION OF RESIDUE RESULTING IN BLOCKAGE AND POSSIBLE INFECTION. THE RESIDENT HAD A FULL BLADDER AND PAIN AND WHEN A NEW FOLEY CATHETER WAS INSERTED SHE HAD UPWARDS OF 900CC OF URINE IN HER BLADDER. ADDITIONALLY, THE SILVER LINED CATHETERS ARE DIFFICULT TO FLUSH WHEN THEY BLOCK.

  Patient problems: Pain; Urinary Retention

  MAUDE report 11171296 ↗
• MalfunctionJan 12, 2021Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THE CATHETERS FAIL TO LAST ONE MONTH AND ACCUMULATION OF RESIDUE RESULTS IN BLOCKAGE AND POSSIBLE INFECTION. ADDITIONAL INFORMATION FROM THE CUSTOMER STATED THE CATHETERS ARE PLUGGING APPROXIMATELY 2 WEEKS AFTER INSERTION. WHEN THE CATHETERS ARE REMOVED THEY CANNOT SEE INSIDE THE CATHETER THEREFORE IT IS UNKNOWN IF SEDIMENT IS BUILDING UP; THIS IS SPECULATION ONLY. ALSO, WHEN THE CATHETER BLOCKS IT IS IMPOSSIBLE TO FLUSH THEM REQUIRING MORE FREQUENT CHANGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11155964 ↗
• MalfunctionDec 16, 2020Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED THAT THE CATHETER FAILED TO LAST ONE MONTH. THERE WAS AN ACCUMULATION OF RESIDUE RESULTING IN BLOCKAGE AND POSSIBLE INFECTION. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON DECEMBER 30, 2020, STATED THAT THE CATHETER PLUGGED APPROXIMATELY TWO WEEKS AFTER INSERTION. WHEN THE CATHETER WAS REMOVED, THEY COULD NOT SEE INSIDE OF THE CATHETER THEREFOR IS IT UNKNOWN IF SEDIMENT WAS BUILDING UP, THIS IS SPECULATION ONLY. ADDITIONALLY, WHEN THE SILVER LINED CATHETERS BLOCK, IT IS IMPOSSIBLE TO FLUSH THEM, THEY SIMPLY BLOCK WHICH REQUIRES MORE FREQUENT CHANGES. NO FURTHER SPECIFIC INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 11018850 ↗