SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter A899914Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741074004), received between Oct 10, 2018 and Aug 30, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Component Missing” (3 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-3114-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE FROM FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20107570 ↗
• MalfunctionJul 9, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT 14FR FOLEY CATHETER KIT WAS MISSING STERILE GLOVES AS WELL AS POVIDONE-IODINE PACKET. PATIENT WAS BROUGHT TO OPERATING ROOM FOR A RETAINED PLACENTA. FOLEY CATHETER WAS NECESSARY DUE TO GENERAL ANESTHESIA. NURSE WENT TO PUT FOLEY CATHETER IN AND WAS MISSING THESE ITEMS IN THE KIT. THE YELLOW STICKER WAS PART OF A RECENT RECALL NOTIFICATION BUT THE RECALL DID NOT INCLUDE THE POVIDONE AND THE PACKAGE WAS NOT LABELED ABOUT THE GLOVES. THERE WERE OTHERS WITH THE SAME LOT NUMBER THAT DO HAD THE STICKER NOTING NO STERILE GLOVES. THE OTHERS WITH THIS LOT NUMBER DO CONTAIN IODINE PACKETS, HOWEVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19702478 ↗
• InjuryDec 26, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FOLEY CATHETER PRIOR TO SECURING TO STAT LOCK PATIENT EXPRESSED URGE TO VOMIT. NURSE RAISED HEAD OF BED AND PROVIDED EMESIS BAG AND PATIENT REPORTED HER NAUSEA SUBSIDED WITHIN A FEW SECONDS. NURSE LOWERED HEAD OF BED TO SECURE STAT LOCK AND FOLEY CATHETER WAS NOTED TO BE OUT AND IN THE BED WITH THE TIP OF CATHETER MISSING. NURSE INSPECTED BED AND PATIENT FOR MISSING PART BUT WAS UNSUCCESSFUL, CYSTOSCOPY WAS PERFORMED, AND NO FOREIGN BODY FOUND. MISSING CATHETER TIP WAS FOUND ON PATIENT 00:08. PER ADDITIONAL INFORMATION RECEIVED ON 29JAN2024, STATED THAT THE CYSTOSCOPY PERFORMED TO FIND THE TIP. TIP WAS INTACT BEFORE INSERTION. PER CUSTOMER VIA PHONE ON 31JAN2024, STATED THAT ALL LOT NUMBER NGGV1575 HAD BEEN PULLED FROM THE FLOORS AND THIS WAS THE ONLY LOT# AFFECTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 18394866 ↗
• InjuryNov 7, 2019Labelling, Instructions for Use or Training Problem; Use of Device Problem; Labelling, Instructions for Use or Training Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INCIDENT LAST WEEK WHEN A LATEX KIT WAS INSERTED INTO THE PATIENT WHO HAD A LATEX ALLERGY. THE CENTRAL SUPPLY MANAGER AT THE HOSPITAL STATED THAT IT WAS DUE TO HUMAN ERROR ON A FEW DIFFERENT LEVELS. THE HOSPITAL STRUGGLED WITH BEING ABLE TO EASILY IDENTIFY THOSE KITS QUICKLY, BECAUSE BEFORE THE KITS THAT WERE LATEX FREE HAD "NRL" ON THE FRONT, BUT NOW THERE IS NOT AN EASY IDENTIFIER. PER ADDITIONAL INFORMATION RECEIVED FROM THE CENTRAL SUPPLY MANAGER ON 11OCT2019, THE HOSPITAL STATED THAT THE STAFF INCORRECTLY PLACED THE NON-LATEX STICKER ON THE KIT. THE SUPPLY MANAGER STATED THIS WAS ALLOWING TOO MUCH ROOM FOR HUMAN ERROR BY HAVING TO PLACE THE STICKERS ON THE KITS BECAUSE NURSING WAS HAVING A DIFFICULT TIME IDENTIFYING THE PRODUCTS. THE HOSPITAL ASKED IF BARD IS DOING ANYTHING TO ADDRESS IT. PER ADDITIONAL INFORMATION RECEIVED FROM THE CENTRAL SUPPLY MANAGER ON 16OCT2019, SHE CONFIRMED THAT THE CAUTION STATEMENT WAS ON THE SIDE OF THE KIT. THE PATIENT RECEIVED MEDICATION IN THE HOSPITAL FOR THE LATEX REACTION. THE NAME OF THE MEDICATION WAS CURRENTLY NOT KNOWN.

  Patient problems: Patient Problem/Medical Problem; Reaction

  MAUDE report 9290431 ↗
• MalfunctionOct 17, 2018Component Missing

  IT WAS REPORTED THAT THE STAFF WAS PLACING A FOLEY AND HAD A KIT THAT WAS MISSING THE STERILE WATER SYRINGE. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 7973595 ↗
• MalfunctionOct 10, 2018Component Missing

  IT WAS REPORTED THAT THE TRAY WAS MISSING THE PREFILLED SALINE SYRINGE.

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

  MAUDE report 7953698 ↗