SureStep™ Foley Tray System Bard® Lubricath Foley A800361Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741073939), received between Oct 10, 2018 and Dec 24, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Component Missing” (4 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Jun 25, 2026Class IIOpen, Classified

   Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

   Z-3114-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Aug 5, 2021Class IIOpen, Classified

   There is potential for packaging defects that may impact the sterile barrier.

   Z-2531-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A STERILE WATER PRODUCT ABOUT TO BE USED FOR A FOLEY CATHETER AND IT WAS FOUND TO BE CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21011078 ↗
• MalfunctionMar 1, 2021Inadequate Instructions for Healthcare Professional; Illegible Information; Inadequate Instructions for Healthcare Professional; Illegible Information

  IT WAS REPORTED THAT THE PRODUCT DID NOT VISIBLY STATE THAT IT WAS MADE OF LATEX. THIS HAD LED TO CONFUSION AND INCORRECT CATHETER PLACEMENT. HENCE THE LATEX WARNING WAS INSIDE OF THE PACKAGING AND THE CUSTOMER PREFERRED TO BE ON THE EXTERIOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396364 ↗
• MalfunctionJan 14, 2020Gel Leak; Output below Specifications; Gel Leak

  IT WAS REPORTED THAT THERE WAS NO END ON THE CAP OF THE SALINE AND THE PLUNGER WAS BACK AT THE ORIGINAL POSITION (10 CC MARK) BUT ONLY 3 CC OF LIQUID WAS IN THE SYRINGE.

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

  MAUDE report 9585934 ↗
• MalfunctionMar 4, 2019Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT WHEN REMOVING THE FOLEY CATHETER, A HEALTH PROFESSIONAL ATTEMPTED TO WITHDRAW WATER FROM THE BALLOON WITH SYRINGE AND ONLY 5CC WITHDREW DESPITE MULTIPLE ATTEMPTS. THE CATHETER WAS CUT WITHOUT RELEASE OF REMAINDER FLUID. HEALTH CARE PROFESSIONAL THEN ATTEMPTED TO "MILK" THE BULB WITHOUT SUCCESS. THE FOLEY WAS REMOVED WITH PARTIALLY INFLATED BALLOON.

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

  MAUDE report 8388652 ↗
• MalfunctionJan 23, 2019Component Missing

  IT WAS REPORTED THAT THE 10CC STERILE WATER SYRINGE WAS MISSING FROM THE TRAY. ADDITIONAL INFORMATION FROM A MEDWATCH WAS RECEIVED ON 07-FEB-2019. THE TRAY WAS BEING USED FOR A DEMO DURING AN EDUCATIONAL VIDEO.

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

  MAUDE report 8270768 ↗
• MalfunctionJan 8, 2019Burst Container or Vessel; Material Split, Cut or Torn; Burst Container or Vessel

  IT WAS REPORTED THAT WHEN THE FOLEY CATHETER WAS REMOVED FROM THE PATIENT, THERE WAS A TEAR ON THE BALLOON AREA. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8228947 ↗
• MalfunctionOct 10, 2018Component Missing

  IT WAS REPORTED THAT THE FOLEY TRAY WAS MISSING THE CATHETER AND THE STERILE WATER SYRINGE.

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

  MAUDE report 7953739 ↗
• MalfunctionOct 10, 2018Component Missing

  IT WAS REPORTED THAT THE FOLEY TRAY WAS MISSING THE CATHETER AND THE STERILE WATER SYRINGE.

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

  MAUDE report 7953735 ↗
• MalfunctionOct 10, 2018Component Missing

  IT WAS REPORTED THAT THE FOLEY TRAY WAS MISSING THE LUBRICATING JELLY SYRINGE AND THE PERI-CARE KIT (SOAP TOWELETTES AND HAND SANITIZER).

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

  MAUDE report 7953730 ↗