Bard® Foley Tray With Lubri-Sil® All-Silicone Foley Catheter 908316Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741033087), received between Nov 19, 2020 and Nov 19, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER WHICH WAS INFLATED IN THE MALE PATIENT WAS LEAKED DUE TO A HOLE IN THE BALLOON AND THE CATHETER FELL OUT . A SECOND CATHETER WAS INSERTED AND INFLATED PRIOR TO INSERTION. AFTER INSERTION A POPPING SOUND WAS NOTED AND THE CATHETER WAS FELL OUT. ALSO, REPORTED THAT THE THIRD ATTEMPT OF THE FOLEY CATHETER WAS UNSUCCESSFUL DUE TO THE CATHETER WAS UNABLE TO PASS THROUGH THE PROSTATE. PER FOLLOW-UP VIA EMAIL ON 29OCT2020, THERE WAS NO IMPACT TO THE PATIENT. IT WAS NOTED THAT THERE WAS NO FURTHER FOLEY CATHETER WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10868903 ↗
• MalfunctionNov 19, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER WHICH WAS INFLATED IN THE MALE PATIENT WAS LEAKED DUE TO A HOLE IN THE BALLOON AND THE CATHETER FELL OUT. A SECOND CATHETER WAS INSERTED AND INFLATED PRIOR TO INSERTION. AFTER INSERTION A POPPING SOUND WAS NOTED AND THE CATHETER WAS FELL OUT. ALSO, REPORTED THAT THE THIRD ATTEMPT OF THE FOLEY CATHETER WAS UNSUCCESSFUL DUE TO THE CATHETER WAS UNABLE TO PASS THROUGH THE PROSTATE. PER FOLLOW-UP VIA EMAIL ON 29OCT2020, THERE WAS NO IMPACT TO THE PATIENT. IT WAS NOTED THAT THERE WAS NO FURTHER FOLEY CATHETER WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10868817 ↗