SureStep™ Foley Tray System Bardex® All- Silicone Foley Catheter Tray A902416Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741074042), received between Feb 21, 2018 and Jan 3, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (2 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-3115-2026 · 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-2539-2021 · 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.

• MalfunctionJan 3, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PLACE ON THE FOLEY METER BAG WHERE THE DRAIN TUBING WAS ATTACHED HAD MANUFACTURING ISSUES. WHEN THE DRAIN TUBE WAS HEAT PRESSED ON THE PROCESS WAS ALSO MELTING THE BACK PORTION OF THE BAG TO THE FRONT AND TUBING AREA ESSENTIALLY SEALING THE BACK OF THE BAG TO THE TUBING HOLE ON THE FRONT AND MAKING IT UNABLE TO EMPTY THE BAGS OF URINE. IF THE CUSTOMER ATTEMPTED TO SEPARATE THE AREA, THE EDGE OF THE BAG OR THE AREA AROUND THE TUBING WOULD TEAR AND SPILL OR LEAK URINE OUT ONTO THE FLOOR OR ON THE HANDS OF THE CUSTOMER. CUSTOMER STATED THAT THIS HAD BEEN OCCURRING OFTEN SINCE THE BAGS WERE REDESIGNED AND THE DRAIN TUBE WITH PLASTIC CLAMP WAS ADDED TO REPLACE THE DRAIN TUBE WITH METAL CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066316 ↗
• MalfunctionSep 15, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT FOLEY TRAY DID NOT CONTAIN A LABEL AND ONLY HAD 1CC OF STERILE WATER VERSUS 10CC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17754829 ↗
• MalfunctionSep 7, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT FOLEY TRAY DID NOT CONTAIN A LABEL AND ONLY HAD 1CC OF STERILE WATER VERSUS 10CC .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17697792 ↗
• MalfunctionMar 31, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE DRAINAGE PORT CONNECTED TO THE GREEN PORT TO DRAIN URINE OUT OF THE FOLEY DRAIN BAG APPEARED TO BE FUSED TOGETHER WHERE THERE WAS JUST A TRICKLE OF URINE ALLOWED TO DRAIN. HOWEVER, THE BAG COULD BE DRAINED IF FLOWED BACK INTO THE HARD PLASTIC SQUARE PART IN THE FRONT OF THE BAG WHERE THE NOZZLE COULD BE SCREWED OFF TO EMPTY THE URINE. STATED THAT THE FOLEY CATHETER WAS REMOVED FROM PATIENT AND FURTHER INVESTIGATION SHOWED THE BAG WAS DEFINITELY FUSED TOGETHER AT THE SITE OF EMPTYING INTO THE GREEN PORT TO EMPTY. WHEN THE BAG WAS PULLED ON IN THAT AREA TO SEE IF IT WOULD RELEASE, IT TORE. CUSTOMER STATED THAT NEW FOLEY PLACED IN PATIENT WITH NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13965906 ↗
• MalfunctionApr 14, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE FOLEY TRAY WAS PUNCTURED AND GOT DAMAGED, AND SO THE MEDICAL SUPPLIES WERE REFUSED BY THE DISTRIBUTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11665942 ↗
• MalfunctionApr 9, 2019Component Missing

  IT WAS REPORTED THAT THE SURESTEP FOLEY TRAY ARRIVED WITHOUT THE FOLEY CATHETER INCLUDED.

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

  MAUDE report 8494966 ↗
• MalfunctionSep 26, 2018Inflation Problem; Difficult to Insert; Leak/Splash; Material Puncture/Hole; Leak/Splash

  IT WAS REPORTED THAT ONCE THE CATHETER WAS INSERTED INTO THE PATIENT; IT FELL OUT ONCE THE BALLOON WAS INFLATED. A SECOND CATHETER WAS THEN INFLATED OUTSIDE OF THE PATIENT AND IT WAS DETERMINED THAT THERE WAS A PIN HOLE LEAK ON THE BALLOON. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 7909426 ↗
• MalfunctionSep 25, 2018Deflation Problem; Device Fell; Deflation Problem

  IT WAS REPORTED THAT ONCE THE CATHETER WAS INSERTED INTO THE PATIENT; IT FELL OUT ONCE THE BALLOON WAS INFLATED. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 7907718 ↗
• MalfunctionFeb 21, 2018Burst Container or Vessel

  IT WAS REPORTED THAT THE IODINE PACKET HAD BURST IN THE FOLEY TRAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7287900 ↗