SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter A947316Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00801741074141), received between Apr 18, 2017 and Aug 3, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Component Missing” (5 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-3115-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Material Puncture/Hole; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50124268 ↗
• MalfunctionOct 20, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A NURSE OPENED A FOLEY TRAY AND NOTICED THERE WAS A CHALKY RESIDUE ON THE TUBING. ANOTHER FOLEY TRAY WAS OPENED AND THERE WAS ALSO THE SAME CHALKY RESIDUE ON THAT ONE AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23343364 ↗
• MalfunctionSep 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A COMPLAINT FROM THE CLINICAL STAFF ABOUT A LATEX FREE FOLEY KIT HAVING A HAIR SHRINK WRAPPED TO THE FOLEY. A SECOND KIT WAS OPENED WITH A DIFFERENT LOT NUMBER AND THAT KIT WAS NOT AFFECTED. THEY WERE NOT SURE BUT HAD A COMPLAINT REGARDING CATALOG # A947316. THEY WERE STILL WAITING ON THEIR CRD TEAM TO DETERMINE IF THEY NEED TO REMOVE THE LOT. THEY JUST WANTED TO GET THAT AND THEN START THE INVESTIGATION PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073171 ↗
• MalfunctionSep 10, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT THE KIT MISSING COMPONENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23020067 ↗
• MalfunctionAug 12, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT UPON OPENING A BD SURESTEP FOLEY TRAY (CAT #A947316) IN AN OR SUITE, THE RN DISCOVERED A BD EMPLOYEE'S BADGE FROM NOGALES, MX PLANT INSIDE THE STERILE TRAY. THIS IS A SERIOUS BREACH OF STERILIZATION PROTOCOL AND RAISES CONCERNS ABOUT THE INTEGRITY OF YOUR MANUFACTURING PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22787726 ↗
• MalfunctionJun 24, 2025Deflation Problem; Defective Component; Infusion or Flow Problem

  RN COULDN'T PULL ANYTHING FROM THE BALLOON. RN HAD TO REPOSITION THE PATIENT, TILT THE BED AND SLIGHTLY TUG ON THE FOLEY TO BE ABLE TO GET ANYTHING OUT. EVENTUALLY RN WAS ABLE TO PULL THE WHOLE 10 ML

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318660 ↗
• MalfunctionMar 26, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT DURING FOLEY LIFECYCLE ASSESSMENT, THE FOLEY TRAY THAT THE NURSE PULLED FROM THEIR SUPPLY ROOM DID NOT HAVE IODINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21696649 ↗
• MalfunctionJul 16, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THEY INSERTED FOLEY CATHETER AND WENT TO DEFLATE BALLOON AND WOULD NOT DEFLATE, PULLED A SECOND ONE SAME ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19749851 ↗
• MalfunctionJun 19, 2024Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT WITHIN THE LAST COUPLE DAYS, THEY HAD FOUR INCIDENTS OF SURESTEP FOLEY TRAYS FAILING IN THE MIDDLE OF PROCEDURES, STATED THAT TWO CATHETERS WOULD NOT DEFLATE. ONE CATHETER WOULD NOT INFLATE. ONE CATHETER BURST INSIDE A PATIENT. PER FOLLOW UP VIA PHONE ON 07JUNE2024, IT WAS REPORTED THAT THIS INCIDENT HAD HAPPENED ABOUT 4-5 ADDITIONAL TIMES. THEY HAD ALREADY FILED A COMPLAINT REGARDING THEM. THERE WAS NO PATIENT INJURY, BUT PATIENT(S) WAS IMPACTED DUE TO THE BALLOON BURSTING INSIDE OF THEM. THEY DID NOT KNOW HOW IT WAS REMOVED BECAUSE THAT WAS CLINICAL AND WAS NOT CLINICAL. THEY COULD NOT PROVIDE ANY MORE INFORMATION REGARDING THE INCIDENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567078 ↗
• MalfunctionMay 24, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE FLUID TO FILL THE FOLEY BALLOON CAME WITH SEDIMENT IN THE FLUID. THEY HAD PRODUCT FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391910 ↗
• MalfunctionMay 22, 2024Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping; Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT WHILE TRYING TO PLACE A FOLEY CATHETER ON A PATIENT, THEY NOTICED A HAIR FOLLICLE WAS FOUND ON THE ADHESIVE PART OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370259 ↗
• MalfunctionMay 6, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT SYRINGE FROM FOLEY TRAY BROKE WHILE USING AQUAFLATE STERILE WATER SYRINGE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247625 ↗
• MalfunctionMar 15, 2024Gel Leak; Gel Leak

  IT WAS REPORTED THAT LUBRICATING JELLY SYRINGE OF FOLEY TRAY WAS PRESENT BUT EMPTY. LUBE PROVIDED FROM ANOTHER SOURCE OUTSIDE OF PRODUCT. PRODUCT USED AND THEN DISPOSED OF IN THE PROPER FASHION. UNABLE TO PROVIDE DEFECTIVE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18913977 ↗
• MalfunctionFeb 23, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE CUSTOMER WERE HAVING MULTIPLE INCIDENTS OF FOLEY CATHETER (B)(6)BALLOONS NOT DEFLATING. THEY HAD (B)(4) INCIDENTS. ONE AFFECTED CATHETER WAS SAVED (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18766424 ↗
• MalfunctionAug 19, 2021Short Fill; Short Fill

  IT WAS REPORTED THAT THE FOLEY TRAY KITS HAD THE BETADINE SWABS IN THEM WHICH HAD A VERY SMALL AMOUNT OF BETADINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12344751 ↗
• MalfunctionJul 9, 2021Short Fill; Short Fill

  IT WAS REPORTED THAT THE FOLEY TRAY WAS OPENED AND EMPTY SYRINGE WAS FOUND. PER VIA EMAIL ON 25JUN21, THE BARD TRAY WAS OPENED AND THE CUSTOMER DISCOVERED THAT THE LUBE SYRINGE WAS EMPTY. PER FOLLOW UP INFORMATION VIA PHONE ON 02JUL21, IT WAS STATED THAT THE LUBRICATION TUBE WAS EMPTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12147807 ↗
• MalfunctionMay 26, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE SURE STEP FOLEY TRAY SYSTEM DID NOT COME WITH 10CC SYRINGE FILLED WITH STERILE WATER. THIS SHOULD BE IN THE KIT AS THIS WAS USED FOR BALLOON INFLATION OF THE URINARY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11890545 ↗
• MalfunctionMay 26, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE SURESTEP FOLEY TRAY SYSTEM DID NOT CONTAIN 10CC SYRINGE FILLED WITH STERILE WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11889447 ↗
• MalfunctionJan 7, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE CATHETER WAS PLACED AND 10CC STERILE WATER WAS INSTILLED IN BALLOON EASILY. LATER, IT WAS OBSERVED THAT CLEAR YELLOW URINE WAS DRAINING AND PATIENT COMPLAINTS OF BURNING. THE CATHETER WAS CHECKED AND REPORTING NURSE WAS UNABLE TO REMOVE ANY SALINE FROM BULB. CATHETER SLID OUT OF PATIENT WITH BULB COMPLETELY DEFLATED.

  Patient problems: Burning Sensation; No Code Available

  MAUDE report 11132153 ↗
• MalfunctionAug 7, 2020Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY INSERTED INTO THE PATIENT 4 HOURS AFTER THE PRE-SURGERY. THE CATHETER INFLATED WITH NO DIFFICULTIES. WHILE ATTEMPTING TO REMOVE FOLEY, IT WOULD NOT DEFLATE. THE CATHETER WAS PUSHED INTO THE BLADDER TO ENSURE THE BLADDER NECK WAS NOT TENSED UP KEEPING THE BALLOON INFLATED. THE SYRINGE WAS PULLED ON SLOWLY, PULLED QUICKLY, AND ABOUT 1/2CC OF AIR WAS PUSHED IN WITHOUT SUCCESS. THE INFLATION ARM WAS THEN CUT TO ALLOW THE FLUID TO DRAIN WHICH PROVED UNSUCCESSFUL. PER FOLLOW UP RECEIVED FROM THE IBC REPRESENTATIVE ON 27JUL2020, THE BALLOON APPEARED TO HAVE A TEAR AND WOULD NOT REQUIRE ANY SURGICAL INTERVENTION FOR REMOVAL. THE PATIENT REPOSITIONED AND FOLEY FELL OUT. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient; Patient Problem/Medical Problem

  MAUDE report 10378570 ↗
• MalfunctionAug 23, 2019Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE FOLEY TRAY WAS NOT SEALED PROPERLY.

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

  MAUDE report 8925093 ↗
• MalfunctionJun 11, 2019Break; Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FOLEY HAD A SLIT IN IT.

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

  MAUDE report 8688546 ↗
• MalfunctionDec 29, 2018Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON BURST WHILE IN THE PATIENT. IT WAS LATER REPORTED FROM THE COMPLAINANT ON (B)(6) 2018, THAT NO MEDICAL INTERVENTION WAS REQUIRED. FOLEY WAS DISCONTINUED AND REPLACED IN PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient; Patient Problem/Medical Problem

  MAUDE report 8205346 ↗
• MalfunctionJul 23, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE SYRINGE BROKE OFF IN THE PORT ACCESS PRIOR TO PATIENT PLACEMENT.

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

  MAUDE report 7711724 ↗
• MalfunctionApr 23, 2018Burst Container or Vessel; Burst Container or Vessel; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE CATHETER BALLOON LEAKED AND APPEARED TO HAVE A PUNCTURE SITE WHERE THE FLUID LEAKED. COMPLAINANT REPORTED THE BALLOON WAS INFLATED AFTER INSERTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7452374 ↗