SureStep™ Foley Tray System Bardex® IC Complete Care® A304416ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741104206), received between Oct 24, 2019 and Aug 14, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (2 reports).

1 FDA recall record name this device's identifier, 1 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-3116-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT CUSTOMER ORDERED 2 CASES OF SAMPLES OF COUDE BARDEX IC FOLEYS. CUSTOMER HAD NOT OPENED EACH TRAY BUT SO FAR 2 OUT OF EACH BOX WERE STANDARD LATEX AND NOT BARDEX IC FOLEY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22805351 ↗
• MalfunctionAug 12, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THEY ORDERED 2 CASES OF SAMPLES - A304416A AND A304716A BOTH SHOULD BE COUDE BARDEX IC FOLEYS. THEY HAD NOT OPENED EACH FOLEY TRAY BUT SO FAR 2 OUT OF EACH BOX WERE THEIR STANDARD LATEX AND NOT BARDEX IC. PER FOLLOW UP RECEIVED VIA EMAIL ON 16SEP2025 STATED THAT THEY WERE NEVER IN CONTACT WITH A PATIENT. THEY STILL HAD THE UNOPENED FOLEYS. THEY RECEIVED A RETURN BOX BUT AM NOT SURE IF THEY WILL ALL FIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22782985 ↗
• MalfunctionJan 31, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT CATHETER STUCK TO ALL THE PACKAGING AND THE BLUE SLEEVE THAT IT COMES IN WAS ALREADY OPENED AND THERE WAS MARK ON THE CATHETER WHERE IT WAS STICKING. IN THIS KIT THERE WAS NO CAP ON THE LUBRICATING JELLY SYRINGE AND IT WAS FOUND LYING IN THE TRAY WITH THE LUBRICATING JELLY OUT OF THE SYRINGE AND DRIED UP IN THE KIT AND INSIDE THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18613690 ↗
• MalfunctionMar 28, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE FOLEY CATHETER TRAY SYSTEM DID NOT INCLUDE THE SYRINGE OF LUBRICATING JELLY. CUSTOMER STATED THAT TWO SYRINGES OF STERILE WATER INSTEAD OF LUBRICATING JELLY SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16627686 ↗
• MalfunctionOct 12, 2021Partial Blockage; Insufficient Device Problem Information; Partial Blockage; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE SUBSTITUTE FOLEY CATHETERS WERE CLOGGING AND WERE HAVING TO BE REPLACED. IT WAS STATED THAT THE STAFFS WERE THINKING THEY WERE ISOLATED INCIDENTS UNTIL THEY STARTED COMPARING NOTES AND REALIZED THERE SO MANY ISSUES. THE NURSES HAD BEEN ASKED TO FILL OUT SAFETY REPORTS ON THE PATIENTS THAT HAD NEEDED THEIR FOLEY REPLACED. ALSO STATED THAT ONE NURSE ALONE HAD ABOUT 3 TO REPLACE OVER THE LAST WEEK. IT WAS ALSO STATED THAT THE CUSTOMER WAS HAVING TROUBLE IN IDENTIFYING THE MODEL NUMBER AND THE ONLY IDENTIFYING INFORMATION THAT THE CUSTOMER GOT FROM THE STAFFS WAS THAT THE IMAGE OF THE BAG THAT HAD A DIFFERENT CLAMP THAN NORMAL SURESTEP TRAYS. PER ADDITIONAL INFORMATION RECEIVED ON 05OCT2021, IT WAS REPORTED THAT THE FOLEY HAD CLOGGING AND THE PATIENT SAFETY REPORTS WERE FILED BUT NO PATIENT HARM WAS REPORTED. CUSTOMER CONFIRMED ONLY 3 INCIDENTS THAT WERE REPORTED TO THEM. THEY WERE USING BARD FOLEY CARE KITS, SUBSTITUTE FOR THE SURESTEP TRAYS AND COULD NOT IDENTIFY WHICH TRAYS WERE IN EACH DEPARTMENT AT THE TIME OF THE INCIDENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12616846 ↗
• MalfunctionOct 6, 2021Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE SUBSTITUTE FOLEY CATHETERS WERE CLOGGING AND WERE HAVING TO BE REPLACED. IT WAS STATED THAT THE STAFFS WERE THINKING THEY WERE ISOLATED INCIDENTS UNTIL THEY STARTED COMPARING NOTES AND REALIZED THERE SO MANY ISSUES. THE NURSES HAD BEEN ASKED TO FILL OUT SAFETY REPORTS ON THE PATIENTS THAT HAD NEEDED THEIR FOLEY REPLACED. ALSO STATED THAT ONE NURSE ALONE HAD ABOUT 3 TO REPLACE OVER THE LAST WEEK. IT WAS ALSO STATED THAT THE CUSTOMER WAS HAVING TROUBLE IN IDENTIFYING THE MODEL NUMBER AND THE ONLY IDENTIFYING INFORMATION THAT THE CUSTOMER GOT FROM THE STAFFS WAS THAT THE IMAGE OF THE BAG THAT HAD A DIFFERENT CLAMP THAN NORMAL SURESTEP TRAYS. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2021, IT WAS REPORTED THAT THE FOLEY HAD CLOGGING AND THE PATIENT SAFETY REPORTS WERE FILED BUT NO PATIENT HARM WAS REPORTED. CUSTOMER CONFIRMED ONLY 3 INCIDENTS THAT WERE REPORTED TO THEM. THEY WERE USING BARD FOLEY CARE KITS, SUBSTITUTE FOR THE SURESTEP TRAYS AND COULD NOT IDENTIFY WHICH TRAYS WERE IN EACH DEPARTMENT AT THE TIME OF THE INCIDENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12584837 ↗
• MalfunctionOct 24, 2019Material Fragmentation; Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE SYRINGE HAD A LARGE PIECE OF HARD PLASTIC DEBRIS WITHIN THE SOLUTION. THE DEFECT WAS NOTICED BEFORE BEING USED ON THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9233543 ↗