SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter A948316Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741100925), received between Jul 17, 2023 and Apr 22, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (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. 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.

• MalfunctionApr 22, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT 10CC STERILE WATER SYRINGE FOR BALLOON INFLATION WAS ONLY 3CC VOLUME AND HAD NOT CAP ON IT. THIS KIT HAD THE YELLOW STICKER STATING NO STERILE GLOVES WHICH WAS RECENTLY REQUESTED TO BE REM FROM THEIR SHELVES AND REPLACED WITH KIT THAT HAD NEC PARTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881383 ↗
• MalfunctionApr 21, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT 10CC STERILE WATER SYRINGE FOR BALLOON INFLATION WAS ONLY 3CC VOLUME AND HAD NOT CAP ON IT. PLEASE NOTE THAT KIT HAD THE YELLOW STICKER STATED NO STERILE GLOVES WHICH WAS RECENTLY REQUESTED TO BE REMEMBER FROM THEIR SHELVES AND REPLACED WITH KIT THAT HAD NEC PARTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873061 ↗
• MalfunctionMar 21, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT BROKEN OR COMPROMISED TUBING AND LEAKING. TUBING ON FOLEY CATHETER CRACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662947 ↗
• MalfunctionJul 17, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT FOLEY TRAY 10CC SYRINGE OF STERILE WATER TIP BROKE OFF IN THE INFLATION PORT. PER FOLLOW UP VIA EMAIL ON (B)(6)2023, IT WAS STATED THAT THE ONLY SAMPLE AVAILABLE WAS THE FOLEY THAT HAD A HOLE IN THE TUBING, NOT THE FOLEY WHERE THE BALLOON WAS LOPSIDED BECAUSE IT WAS USED, THEY COULD NOT SAVE IT. PATIENT WITH LOPSIDED FOLEY WAS OKAY, BUT WAS VERY UNCOMFORTABLE THEREFORE THEY REMOVED THE FOLEY AND THAT WAS WHEN THEY REALIZED THAT THE PRODUCT WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17336715 ↗