SureStep™ Foley Tray System Bardex® IC Complete Care® A303316ARecalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00801741073793), received between May 10, 2017 and Oct 15, 2025 — classified as 62 malfunctions.

The most frequently reported specific device problem is “Component Missing” (12 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-3116-2026 · 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-2525-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THERE WAS NO LUBRICATION SYRINGE INSIDE THE FOLEY KIT FOR INSERTION AND HAD 2 STERILE WATER SYRINGES INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23289601 ↗
• MalfunctionSep 9, 2025Gel Leak; Gel Leak

  IT WAS REPORTED THAT THE SURESTEP FOLEY TRAY WAS DAMAGED, LEAKING OBSERVED WITHIN INNER PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006371 ↗
• MalfunctionAug 12, 2025Component Missing; Component Misassembled; Component Missing; Component Misassembled

  IT WAS REPORTED THAT THE FOLEY BALLOON INFLATION SOLUTION WAS LUBRICATING GEL NOT STERILE WATER. BOTH SYRINGES WERE LABELED AS GEL, BUT THE 2ND GEL WAS IN THE POSITION OF THE STERILE WATER, BASICALLY 2 LUBRICATING GEL SYRINGES CAME IN THE KIT AND NO STERILE WATER. NO IMPACT TO PATIENT LUCKILY IT WAS NOTICED BEFORE INFLATING BALLOON THAT THE SYRINGE IN THE SPOT STERILE WATER SPOT WAS ALSO LUBRICATING GEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784088 ↗
• MalfunctionJun 17, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT MATERIAL # A303316A LOT # NGJX6399 OUT DATE 31MAY2027. THERE WAS A PICTURE OF THE FRONT AND THE BACK. ONE TRAY SAID LATEX FREE THE OTHER SAID LATEX, THEY WERE THE SAME FOLEY TRAYS WITH THE SAME PRODUCT NUMBER, LOT NUMBER AND OUTDATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236634 ↗
• MalfunctionJun 3, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THEY WERE REACHING OUT ON BEHALF OF ASPIRUS WAUSAU HOSPITAL. THEY HAD THE END USER REACH OUT WITH THE CONCERN/ QUESTION. PRODUCT #A303316A, LOT #NGJX6399, OUT DATE (B)(6) 2027. THERE WAS A PICTURE OF THE FRONT AND THE BACK. ONE TRAY SAYS LATEX FREE THE OTHER SAYS LATEX, THEY WERE THE SAME TRAYS WITH THE SAME PRODUCT NUMBER, LOT NUMBER AND OUTDATE. THEY NEED TO KNOW HOW ONE CAN BE LATEX AND THE OTHER LATEX FREE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131365 ↗
• MalfunctionJun 3, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT CUSTOMER RECEIVED 1 CASE OF BRDA303316A FOLEY TRAY WITH BRDA303416A PRODUCT INSIDE UNDER LOT#NGJX6399.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131356 ↗
• MalfunctionMay 28, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT IN FOLEY TRAY, 10CC SYRINGE OF STERILE WATER WAS NOT CAPPED AND HAD 1ML OF FLUID IN IT. AS PER INFORMATION RECEIVED VIA MAIL ON 29MAY2025, IT WAS REPORTED THAT THERE WERE NO PHYSICAL SAMPLE AVAILABLE. ALL IDENTIFYING INFORMATION AVAILABLE IN THE REPORT, SERIAL NUMBER NOT AVAILABLE. THERE IS NO DETECTABLE HARM TO PATIENT, MEDICAL INTERVENTION WAS NOT REQUIRED, THE REPORT AS SUBMITTED WAS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22097298 ↗
• MalfunctionMay 14, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THERE WAS REFERENCE IN INSERT VERSUS REFERENCE IN LABEL DID NOT MATCH IN FOLEY TRAY. PER FOLLOW UP RESPONSE RECEIVED VIA EMAIL ON 09MAY2025, THE SITUATION WAS THAT IN THE LABEL CASE REFLECT REORDER A303316A, BUT IN THE COMPONENT REFLECT A303416A REFERENCE DID NOT MATCH. NO IMPACT TO THE PATIENT, THIS WAS CONFIRMED DURING INCOMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22017839 ↗
• MalfunctionApr 16, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT TODAY A LABELLING ISSUE WAS BROUGHT TO THEIR ATTENTION ON 16FR FOLEY CATH TRAYS. THEY ORDER ITEM#: A303316A A 16 FR BARDEX FOLEY CATH TRAY AND THAT WAS WHAT THE OUTSIDE OF THE BOX STATED BUT INSIDE THE LABEL/COVER SHEET OF THE SEALED PACKAGE STATES#: A303416A, INDICATING A LUBRI-SIL CATH. TO MAKE IT MORE CONFUSED, THE BANDED, STERILIZED WRAPPED TRAY ITSELF STATES ITEM#: A303316A. THEY ATTACHED A SCAN OF THE FRONT AND BACK OF THE PACKAGE. THEY CHECKED THE OTHER CASES IN LOT#: NGJX6399 ON THEIR SHELF AND THEY WERE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21849364 ↗
• MalfunctionDec 29, 2024Gel Leak; Gel Leak

  IT WAS REPORTED THAT THE WATER SYRINGE WAS EMPTY WHEN THE FOLEY TRAY KIT WAS OPENED AND THE LUBE SYRINGE WAS ONLY HALF FULL, ALSO STATED THAT THE SYRINGES WERE CRUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032820 ↗
• MalfunctionDec 29, 2024Gel Leak; Gel Leak

  IT WAS REPORTED THAT THE WATER SYRINGE WAS EMPTY WHEN THE FOLEY TRAY KIT WAS OPENED AND THE LUBE SYRINGE WAS ONLY HALF FULL, ALSO STATED THAT THE SYRINGES WERE CRUSTED. PER ADDITIONAL INFORMATION RECEIVED VIA FORM WITH SAMPLE RETURNED ON (B)(6) 2025, WATER SYRINGE CAME EMPTY, AND THE LUBE SYRINGE WAS ONLY HALF FULL, ALSO STATED THAT THE SYRINGES WERE CRUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21032818 ↗
• MalfunctionDec 2, 2024Short Fill; Short Fill

  IT WAS REPORTED THAT DURING FOLEY INSERTION ASSESSMENT, THE NURSE DISCOVERED THAT THE LUBRICANT DID NOT CONTAIN 10CCS OF LUBRICANT, IT CONTAINED LESS THAN 5CCS. PER ADDITIONAL INFORMATION RECEIVED ON 06DEC2024, IT WAS REPORTED THAT THE LACK OF LUBRICANT IN THE SYRINGE WAS DISCOVERED DURING A FOLEY LIFE CYCLE ASSESSMENT, SO NO PATIENT WAS INVOLVED. NO PATIENT IMPACT OR INVOLVEMENT OCCURRED. THE NURSE OPENED THE PROVIDED FOLEY TRAY TO INSERT THE CATHETER INTO A MANNEQUIN, THAT WAS WHEN IT WAS NOTICED THAT THERE WAS NOT 10CCS OF LUBRICANT IN THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20825095 ↗
• MalfunctionOct 4, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THE FOLEY CATHETER WORKED FINE, BUT THE KIT WAS MISSING THE SALINE FLUSH. THE KIT WAS ONE THAT HAD THE YELLOW STICKER THAT NOTED IT DID NOT INCLUDE LATEX GLOVES. THE LEARNING AND DEVELOPMENT (L&D) TEAM DID UTILIZE THE CATHETER WITHOUT ISSUE ONCE THEY ADDED A SALINE FLUSH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20371477 ↗
• MalfunctionSep 23, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THE NURSE OPENED FOLEY TRAY AND TRAY WAS MISSING THE LUBRICANT. THEY GOT ANOTHER TRAY BEFORE INSERTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20278525 ↗
• MalfunctionJul 16, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE INFLATION SYRINGE CAP WAS OFF, AND SYRINGE ONLY HAD 1 CC OF SALINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19752121 ↗
• MalfunctionMay 29, 2024Gel Leak; Gel Leak

  IT WAS REPORTED THAT THE URINARY CATHETERS WITH URINE METER THAT THEY STOCK IN L&D WAS OPENED FOR USE AND THE BETADINE WAS LEAKING AND SPILLED OUT INTO THE KIT. THEY PULLED TWO DIFFERENT KITS AND RAN INTO THE SAME PROBLEM AND CAN VISUALLY SEE BETADINE LEAKAGE ON THE OUTSIDE OF THE THIRD AND LAST CATHETER KIT IN THE PYXIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19413731 ↗
• MalfunctionFeb 20, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A BROWN MATERIAL IN THE STERILE FLUSH THAT WAS INCLUDED IN THE FOLEY KIT. PER CUSTOMER CONFIRMATION RECEIVED ON 06FEB2024, ONLY ONE ITEM WAS REPORTED FOR THE PRODUCT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18739977 ↗
• MalfunctionFeb 13, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A BROWN MATERIAL IN THE STERILE FLUSH THAT IS INCLUDED IN THE FOLEY TRAY. PER CUSTOMER FOLLOW UP RECEIVED ON 18JAN2024, SEH EXPERIENCED A QUALITY ISSUE WITH A BARD BD FOLEY KIT. THIS OCCURRED ON 7C AT SEH EDG. THE SYRINGE WAS NOT OPENED. THE BLACK RUBBER STOPPER WAS NEVER REMOVED. THERE WAS A BROWN FOREIGN OBJECT SEEN JUST ABOVE THE YELLOW ARROW IN THE PHOTO ATTACHED. LOT NUMBER NGHW1475.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695042 ↗
• MalfunctionFeb 5, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE FOLEY TRAY AND THE FLUSH WITHIN THE KIT HAD A FOREIGN PRODUCT IN IT. PER FOLLOW UP VIA EMAIL ON (B)(6) 2024, THE STERILE SALINE SYRINGE IN THE SURESTEP FOLEY TRAY SYSTEM WAS CONTAMINATED, LOOKED LIKE A PIECE OF CARDBOARD WAS IN THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640438 ↗
• MalfunctionDec 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE SYRINGES WERE CRACKED IN THE FOLEY KITS. IT HAPPENED WITH 3 DIFFERENT PATIENTS. FIRST 2 PATIENTS WERE UNKNOWN, THE 3RD HAPPENED ON (B)(6) 2023. PER FOLLOW UP VIA EMAIL ON 05DEC2023, IT WAS REPORTED THAT THE CRACK WERE ON THE BARREL AND THE PLUNGER OF THE SYRINGE. STERILE WATER WAS BEING USED IN THE SYRINGE, THE CRACKS CAUSED A LEAK. NURSING STAFF CAUGHT THE ISSUES BEFORE ISSUE AFFECTED PATIENT. ANOTHER SYRINGE WAS UTILIZED. PER FOLLOW UP VIA EMAIL ON 10JAN2024, IT WAS REPORTED THAT ALL SYRINGES WERE FROM THE SAME LOT NGHV0306.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18378507 ↗
• MalfunctionDec 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE SYRINGES WERE CRACKED IN THE FOLEY KITS. IT HAPPENED WITH 3 DIFFERENT PATIENTS. FIRST 2 PATIENTS WERE UNKNOWN, THE 3RD HAPPENED ON (B)(6) 2023. PER FOLLOW UP VIA EMAIL ON 05DEC2023, IT WAS REPORTED THAT THE CRACK WERE ON THE BARREL AND THE PLUNGER OF THE SYRINGE. STERILE WATER WAS BEING USED IN THE SYRINGE, THE CRACKS CAUSED A LEAK. NURSING STAFF CAUGHT THE ISSUES BEFORE ISSUE AFFECTED PATIENT. ANOTHER SYRINGE WAS UTILIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18377877 ↗
• MalfunctionNov 20, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD HOLES IN THE TUBING WHEN RN TESTED TUBING BEFORE INSERTION. WHEN THE RN TRIED TO PULL FLUID OUT OF THE BALLOON THE HOLES CAUSED PRESSURE IN THE TUBING AND THE WATER WOULD NOT DRAIN. IT COULD HAVE CAUSED HARM TO PATIENT IF IT WAS NOT CAUGHT BEFORE INSERTION. IT APPEARED THE PRODUCT WAS NOT SAVED AND NO PATIENT HARM OCCURRED AS IT WAS CAUGHT BEFORE INSERTION ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169121 ↗
• MalfunctionSep 22, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT FOLEY CATHETER SYRINGE USED TO INFLATE THE BALLOON BROKE WHILE ATTEMPTING TO REMOVE SYRINGE FROM THE PORT AND THE FOLEY CAME BACK OUT OF THE PATIENT'S BLADDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17798955 ↗
• MalfunctionSep 5, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT WHILE COMPLETING INSERTION PORTION OF LCA-BLUE PLASTIC SHEATH COVERING FOLEY WAS WRAPPED AROUND BIFURCATION IN THE SURE STEP TRAY. THERE WAS A HOLE IN THE SHEATH ALLOWING THE WATER INFLATION PORT TO SLIP THROUGH THE SHEATH MADE IT DIFFICULT TO REMOVE PRIOR TO A MOCK INSERTION. THIS MADE IT DIFFICULT TO REMOVE THE BLUE SHEATH IN PREPARATION FOR FOLEY INSERTION. PER FOLLOW UP VIA PHONE ON 30AUG2023, IT WAS REPORTED THAT THIS WAS ONLY A REPORTED EVENT AND NOT A PATIENT-RISK INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682925 ↗
• MalfunctionSep 5, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT WHEN OPENING THE FOLEY TRAY, THE LUBRICANT SYRINGE DID NOT HAVE A CAP ON, AND THERE WAS VERY LITTLE LUBRICANT LEFT. THE REMAINING LUBRICANT WAS DRIED OUT AND UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682266 ↗