SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter A902916Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00801741074073), received between May 18, 2017 and Sep 30, 2026 — classified as 2 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (7 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-2536-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Deformation Due to Compressive Stress

  It was reported that we had challenges with or Foley catheters folding over / kinking when the urine enters the bag. Please see the attached photo.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950938 ↗
• MalfunctionSep 28, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916267 ↗
• MalfunctionSep 21, 2026Failure to Deflate

  Attempted to deflate 16Fr foley catheter for removal but unable to. Added 2cc sterile saline and attempted to deflate again. Only able to remove 4cc. Added 2cc more, then able to deflate fully.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838816 ↗
• MalfunctionMar 4, 2026

  RN WAS ATTEMPTING TO CARE FOR INTUBATED PATIENT, AND WHEN SHE PULLED THE PATIENTS BLANKET BACK, SHE NOTICED A LARGE PUDDLE OF URINE UNDER THE PATIENT. THERE WAS NO OBVIOUS HOLE OR VISUAL FAILURE WITH THE FOLEY, AND IT SEEMED TO JUST NOT BE CONNECTING PROPERLY, LEADING TO THE PUDDLE. THIS RN WAS NOT SURE HOW LONG THE FOLEY HAD BEEN A PROBLEM WITH THIS SPECIFIC PATIENT, BUT THIS AT LEAST THE FIFTH TIME IN THE LAST TWO WEEKS OUR ICU HAS HAD A PROBLEM WITH THIS SPECIFIC TYPE OF FOLEY CATHETER. THIS FAILURE COULD LEAD TO POTENTIAL SKIN BREAKDOWN FOR AN INTUBATED PATIENT, WHICH COULD LEAD TO INFECTION CONTROL ISSUES. ALL FIVE OF THE FAILURES WERE WITH FIVE DIFFERENT PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505543 ↗
• MalfunctionNov 7, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT THE CATHETER KIT WAS SUPPOSED TO HAVE 3 SWAB STICKS BUT ONLY CONTAINED 2 IN THE FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23497574 ↗
• MalfunctionOct 17, 2025Melted; Melted

  IT WAS REPORTED TO SUPPLY DISTRIBUTION THAT PRODUCT A902916, LOT NGKS0308 WAS OPENED AND FOUND TO HAVE A FOLEY CATHETER BAG THAT WAS MELTED TO THE OPENING WHERE THEY WOULD LET URINE OUT, IF THEY WERE EMPTYING A CATHETER. THE NURSE WAS UNABLE TO EMPTY THE FOLEY BECAUSE OF THE OPENING SEALED SHUT AND THEY INDICATED THEY HAD TO GET A NEW BAG. THE NURSE MENTIONED THAT WAS THE SECOND TIME THEY NOTICED THAT EXACT SAME DEFECT, BUT THEY DID NOT COLLECT THE LOT NUMBER THE FIRST TIME AROUND, NOR DID THEY SAVE THE DEFECTIVE PRODUCT. THEY HAD RECEIVED OTHER ISSUES WITH THAT PRODUCT AND LOT YET AND DID NOT HAVE THE DEVICE TO SEND BACK FOR QA BUT DID WANT TO FOLLOW UP TO SEE IF THERE WAS A NEED TO PULL THAT LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23323739 ↗
• MalfunctionMay 5, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE OUTSIDE OF CASE LISTS A902916 AS PART#, PRODUCT INSIDE CASE IS LABELLED A303316A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960952 ↗
• MalfunctionNov 26, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT ONE OF THE FOLEY TRAYS CONTAINED A PREFILLED SYRINGE THAT WAS EMPTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20787464 ↗
• MalfunctionNov 20, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT WHEN OPENED THE FOLEY KIT, IT WAS DISCOVERED THAT THE STERILE WATER SYRINGE USED TO INFLATE THE BALLOON WAS UNCAPPED AND ONLY HAD 1ML OF FLUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20734630 ↗
• MalfunctionNov 18, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT CUSTOMER HAD A DEFECTIVE FOLEY KIT. THE SYRINGE WITH THE STERILE WATER FOR THE BALLOON WAS EMPTY AND HAD NO CAP ON IT. NOT ABLE TO USE PRODUCT. STERILITY CONCERNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20705331 ↗
• MalfunctionNov 15, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE IODINE SWABS HAD BEEN REMOVED FROM THE PACKING OF FOLEY TRAY AND WERE JUST LYING IN THE TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694469 ↗
• MalfunctionNov 15, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT IODINE SWABS HAD BEEN REMOVED FROM THE PACKING AND WERE JUST LYING IN THE FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20693884 ↗
• MalfunctionAug 7, 2024Short Fill; Short Fill

  IT WAS REPORTED THAT EMPTY SYRINGE IN FOLEY TRAY TO FILL BULB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19931378 ↗
• MalfunctionMay 16, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT WHEN FOLEY TRAY WAS USED FOR A DEMONSTRATION OF THE PROCESS WITH A GROUP OF POTENTIAL CUSTOMERS AND SUPPLIERS, THE LUBE SYRINGE IN THE KIT DID NOT HAVE THE CAP, THE SYRINGE WAS ALMOST EMPTY, AND THE LUBE WAS SPILLED ON THE TRAY AND OTHER COMPONENTS. IT WAS CONFIRMED THAT THE SYRINGE CAP WAS NOT LOCATED IN THE TRAY OR THE PACKAGING BAG, THEREFORE IT WAS CONCLUDED THAT SYRINGE DID NOT HAVE THE CAP WHEN PLACED IN THE TRAY. PRODUCT WAS NOT USED IN ANY PATIENT IT WAS JUST FOR DEMONSTRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19330378 ↗
• MalfunctionOct 17, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT 2 FOLEY TRAYS THAT THE SALINE SYRINGE WAS EMPTY. (BATCH#NGHQ2360 AND BATCH#UNK)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17948701 ↗
• MalfunctionSep 12, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT HAIR WAS FOUND IN FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17731097 ↗
• MalfunctionSep 11, 2023

  WHEN THE BARD URINARY CATHETER PACK WAS OPENED, THE GREEN COLLECTION TUBE COMING FROM THE URINARY BAG HAD SOME WHITE STREAKS ON IT. ANOTHER PACK WAS OPENED AND THE SAME FINDINGS WERE NOTED. BOTH PACKS WERE BROUGHT TO THE QUALITY DEPARTMENT/ ADVERSE EVENT COORDINATOR-REPORTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719067 ↗
• MalfunctionMay 9, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT ONE OF THE FOLEY TRAY WAS MISSING THE SWAB STICK AND THEY WERE UNABLE TO PERFORM PROPER INSERTION TECHNIQUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16895217 ↗
• MalfunctionMay 5, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE SWAB STICK IN THE FOLEY TRAY WAS MISSING, SO THEY WERE NOT ABLE TO FOLLOW PROPER INSERTION TECHNIQUE FOR THE FEMALE CLIENT. PER FOLLOW UP VIA EMAIL ON 24APR2023, THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876058 ↗
• MalfunctionSep 2, 2022Gel Leak; Gel Leak

  IT WAS REPORTED THAT THE FOLEY KIT WAS OPEN AND WAS NOTED THAT THE KY JELLY SYRINGE WAS EMPTY. STATED THAT THE SYRINGE WAS REMOVED FROM THE FIELD, AND A NEW KY JELLY WAS OBTAINED TO INSERT THE FOLEY. THERE WAS SOME STICKINESS BELOW THE SYRINGE IN THE TRAY WHICH APPEARED TO BE DRIED OUT JELLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15347705 ↗
• MalfunctionMay 20, 2022Short Fill; Short Fill

  IT WAS REPORTED THAT UPON OPENING THE FOLEY KIT, THE SYRINGE FOR BALLOON INFLATION HAVE ONLY 4 ML OF WATER INSTEAD OF 10 ML OF WATER SO THAT THE SYRINGE WAS REMOVED FROM THE KIT AND A NEW STERILE SYRINGE AND WATER WERE PUT ONTO THE STERILE FIELD TO INFLATE THE BALLOON AFTER FOLEY CATHETER INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14459539 ↗
• MalfunctionMay 7, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE HEADER BAG FOR FOLEY TRAY WAS OPEN UPON OPENING IT FROM THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14316521 ↗
• MalfunctionApr 18, 2022Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE CUSTOMER HAD MULTIPLE COMPLAINTS ABOUT THE SURESTEP FOLEY TRAY SYSTEM THAT THEY HAD IN STOCK. STATED THAT THE MAIN CONCERN WAS FOLEY BAG NOT DRAINING EFFECTIVELY AND THE NURSES HAVE TO PUT THE BAG ON THE FLOOR IN ORDER TO GET IT TO DRAIN. IT WAS STATED THAT THIS WAS A CONCERN WHEN DOING SURGERY AS THE PROVIDER WERE FINDING FULL BLADDERS POSSIBLE LEADING TO ONE INJURY SO FAR. WHILE PUTTING THE BAG ON THE FLOOR WAS HELPING, IT WAS ABSOLUTELY AGAINST ALL INFECTION CONTROL STANDARDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14135657 ↗
• MalfunctionApr 18, 2022Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE CUSTOMER HAD MULTIPLE COMPLAINTS ABOUT THE SURESTEP FOLEY TRAY SYSTEM THAT THEY HAD IN STOCK. STATED THAT THE MAIN CONCERN WAS FOLEY BAG NOT DRAINING EFFECTIVELY AND THE NURSES HAVE TO PUT THE BAG ON THE FLOOR IN ORDER TO GET IT TO DRAIN. STATED THAT THIS WAS A CONCERN WHEN DOING SURGERY, AS THE PROVIDER WERE FINDING FULL BLADDERS POSSIBLE LEADING TO ONE INJURY SO FAR. WHILE PUTTING THE BAG ON THE FLOOR WAS HELPING, WHICH WAS ABSOLUTELY AGAINST ALL INFECTION CONTROL STANDARDS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14135654 ↗
• MalfunctionFeb 8, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE 2 FOLEY TRAY WERE RECEIVED RECENTLY WITHOUT THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13480508 ↗