SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter A942618Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741100819), received between Dec 20, 2019 and Dec 20, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2019Deformation Due to Compressive Stress; Inflation Problem; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT THE BALLOON PORT KINKED, WHICH CAUSED THE PORT TUBING TO EXPAND TO A DANGEROUS LEVEL AND MADE BALLOON INFLATION IMPOSSIBLE. THE FOLEY CATHETER HAD TO BE REMOVED DUE TO THE INABILITY TO INFLATE THE BALLOON. PER FOLLOW UP, THE TUBING WAS KINKED, AND CAUSED THE TUBING DIRECTLY BENEATH THE PORT TO EXPAND OUTWARD AND DID NOT ALLOW FLUID TO FLOW TO THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9503145 ↗