SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter A899916Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741074011), received between Jun 1, 2017 and Jan 23, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (3 reports).

3 FDA recall records name this device's identifier, 3 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-3119-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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 ↗

3. Aug 5, 2021Class IIOpen, Classified

   There is potential for packaging defects that may impact the sterile barrier.

   Z-2534-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Material Fragmentation

  IT WAS REPORTED THAT WHEN NURSE WAS INSERTING A FOLEY CATHETER IN DOCTORS¿ PATIENT, THE SALINE SYRINGE TIP BROKE OFF INSIDE THE PORT WHEN HE HOOKED IT UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24173009 ↗
• MalfunctionAug 14, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT THEY RECEIVED A COMPLAINT FROM CAPITOL HILL OR REGARDING A BARD FOLEY CATH TRAY, #A899916. THE DESCRIPTION OF THE PROBLEM WAS MENTIONED BELOW. THERE WAS NOTHING SAVED FROM THE KIT SINCE THEY WERE ABLE TO ADD THE MISSING ITEM TO CONTINUE USING IT. WHILE PREPARING TO PLACE A FOLEY CATHETER IN A PATIENT FOR A SURGICAL PROCEDURE, THEY WERE OPENING AND PREPPING THE TRAY KIT. THERE WAS NO LUBRICATING JELLY IN THE KIT. THERE WERE 2 STERILE WATER SYRINGES. ANESTHESIA WAS ABLE TO PROVIDE STERILE JELLY TO THEIR FIELD, SO NO HARM OR DELAY WAS NOTED IN PATIENT CARE. THE KIT REF# A899916, LOT# NGKS0068 WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22804280 ↗
• MalfunctionAug 5, 2025Fracture; Fracture

  THE INCLUDED STERILE WATER SYRINGE USED TO INFLATE CATHETER BALLOON SPLIT ALONG THE BARREL WHILE ATTEMPTING TO INFLATE THE BALLOON AFTER COUDE CATHETER INSERTION. STERILE WATER THEN LEAKED OUT THE BARREL OF THE SYRINGE. NO RESISTANCE WAS ENCOUNTERED PRIOR TO SPLIT. USED A NEW STERILE SALINE SYRINGE TO FILL THE BALLOON AFTER WITHDRAWING PREVIOUSLY INSTILLED STERILE WATER WITH DIFFERENT EMPTY SYRINGE. PATIENT WAS NOT AFFECTED. CAN SUBMIT IMAGES OF LABELS IF NEEDED, CURRENTLY HOLDING ONTO SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22713673 ↗
• MalfunctionJul 7, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED WHILE DOING THEIR FOLEY LIFECYCLE ASSESSMENT, NOTICED THAT FOLEY TRAY CONFIGURATION SEEMS OFF. THE UNDERPAD WAS NOT FOLDED THE WAY IT USUALLY WAS. ALSO, THE STERILE WATER AND LUBRICANT JELLY SYRINGES ARE IN WRONG SPOT. THE WATER SYRINGE ON THE RIGHT AND LUBRICANT ON THE LEFT, AND THEREFORE WHEN THEY ATTACH THE WATER SYRINGE IT DID NOT EXPOSE #4 STEP THAT WAS ETCHED ON THE TRAY, WHICH WOULD INSTRUCT DISPENSE LUBE. ALSO, ONE TRAY HAD TWO GLOVES IN, ANOTHER TRAY HAD TWO FENESTRATED DRAPES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412700 ↗
• MalfunctionApr 22, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THIS WAS THE 2ND CATHETER TRAY THAT HAD A YELLOW STICKER THAT STATED THERE WERE NO STERILE GLOVED AND THE STERILE WATER SYRINGE WAS NOT CAPPED AND ONLY HAS 4ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883272 ↗
• MalfunctionJul 16, 2024

  IN ATTEMPT TO REMOVE FOLEY, THE BALLOON WOULD NOT DEFLATE. TRIED MULTIPLE TIMES TO DEFLATE FOLEY BALLOON UNSUCCESSFULLY. DOCUMENTATION STATED 10MLS WAS PUT INTO BALLOON. ONLY ABLE TO DRAW BACK 1/2 ML AND TUBING WOULD COLLAPSE. ASSESSED PENIS AND FOUND BALLOON IN THE SHAFT OF THE PENIS IN THE URETHRA. UROLOGY SAID TO CUT THE FOLEY LINE TO GET THE BALLOON TO DEFLATE SLOWLY WITH PRESSURE. BALLOON WOULD NOT DEFLATE. UROLOGY CONSULTED BEDSIDE. UROLOGY CUT DISTAL END OF FOLEY COMPLETELY OFF AND STILL BALLOON REMAINED INFLATED. UROLOGY PLACED GUIDE WIRE IN BALLOON PORT AND ADVANCED WIRE. REMOVAL OF GUIDEWIRE RESULTED WITH A GUSH OF WATER WITH DEFLATION OF BALLOON. FOLEY REMOVED WITHOUT ISSUE WITH BLOOD PRESENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19748965 ↗
• MalfunctionJan 18, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BLACK FOREIGN OBJECT THAT APPEARED TO BE A FLY BAKED INTO THE INSIDE OF 16FR FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18535366 ↗
• MalfunctionDec 18, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS SOMETHING FLOATING IN THE STERILE SYRINGE OF SALINE IN FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18347708 ↗
• MalfunctionOct 27, 2022Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE STAFF HAD FOLEY TRAY (A899916) FOR PATIENT BUT WAS UNABLE TO USE THIS TRAY BECAUSE IT HAS A METAL CLIP AND STAFF WERE NEW AND DID NOT KNOW WHY THEIR PREDECESSORS HAVE BEEN ABLE TO. STATED THAT STAFF WAS CURRENTLY GRABBING 154006 FROM OTHER UNITS AND SWAPPING THAT PORTION OUT. THEY HAVE BEEN PULLING A DRAINAGE BAG 154006 WITH A PLASTIC DRAINAGE CLIP SEPARATELY TO INSURE THERE WAS NO METAL PRESENT IN CASE THE PATIENT NEEDS TO GO TO MAGNETIC RESONANCE IMAGING (MRI). THEY WERE CURRENTLY BREAKING THE CLOSED SYSTEM TO ADD THIS BAG SINCE IT DID NOT HAVE ANY METAL. STATED THAT THE CUSTOMER COULD CALL FOR LETTER ON MRI SAFETY BAGS WITH METAL DRAINAGE CLIPS SINCE THE MRI INSTRUCTIONS WERE NOT IN THE INSTRUCTIONS FOR USE (IFU).CUSTOMER PREFERENCE: CUSTOMER SAID THEIR PREFERENCE WAS TO HAVE THE FULL KIT (THE A899916 BUT WITHOUT A METAL CLIP).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15680929 ↗
• MalfunctionSep 14, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE CUSTOMER HAD 2 LATEX FOLEY CATHETER TRAYS THAT HAD THE INNER PAPER WRAPPER RIPPED AND TORN, RESULTING IN AN UNSTERILE FIELD FOR TRAYS. THE EXTERNAL DUST COVERS WERE INTACT. THE CUSTOMER MIGHT HAVE A BAD LOT. IT WAS LOOKED LIKE WHATEVER MACHINE BARD HAD TO WRAP THE INSIDE TRAY HAD AN ISSUE AND GRABBED PART OF THE PAPER WRAP AND RIPPED A LARGE BITE OUT OF THE EDGE OF IT. IT MIGHT NOT BE SEEN UNTIL UNWRAP THE TRAY COMPLETELY AND GET READY TO INSERT IT. EMERGENCY DEPARTMENT REPORTED THAT THEY WERE HAVING AN INTERNAL WRAP THAT HAD THE SIDES COMPLETELY CUT OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15418921 ↗
• MalfunctionJul 18, 2022Missing Information; Missing Information

  IT WAS REPORTED THAT THE TWO FOLEY KITS WERE EXACTLY THE SAME. STATED THAT ONE FOLEY KIT HAD A STICKER THAT CONTAINS LATEX, AND ONE DID NOT. CUSTOMER HAD DIFFERENT ITEM NUMBERS BUT WERE STOCKED IN THE SAME BIN AND USED THE SAME FROM A NURSING PERSPECTIVE. ITEM#A300316A HAD A WHITE STICKER THAT STATED IT CONTAINS LATEX AND ITEM#A899916 HAD NO STICKER, AND IT DID NOT INDICATE THAT IT WAS LATEX FREE AND CUSTOMER DID NOT KNOW IF IT CONTAINED LATEX OR NOT. CUSTOMER PREFERENCE: ITEM#A300316A HAD A WHITE STICKER THAT STATED IT CONTAINS LATEX AND LATEX STICKER WAS IN LOWER RIGHTHAND CORNER. THE USER WOULD RECOMMEND A BRIGHT PINK STICKER OR SOMETHING A LITTLE MORE FLASHY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15047684 ↗
• MalfunctionJul 12, 2022Missing Information; Missing Information

  IT WAS REPORTED THAT THE BOTH OF THE FOLEY KITS CONTAINED LATEX BUT ONLY ONE WAS LABELED AS CONTAINING LATEX WHILE THE OTHER DID NOT WHICH LED TO A PATIENT SAFETY EVENT. SOME LATEX CONTAINING PRODUCTS HAVE LARGER PICTURES ON THE PACKAGE WHILE OTHERS HAVE SMALL PRINT OR NO INDICATION THAT LATEX WAS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14986902 ↗
• 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 12344780 ↗
• MalfunctionJun 28, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE SWABS WERE MISSING FROM THE FOLEY KIT TO CLEAN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12081467 ↗
• MalfunctionSep 17, 2020Contamination; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A LIQUID SUBSTANCES IN THE BOTTOM OF THE BIN THAT PENETRATED THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10548295 ↗
• MalfunctionNov 11, 2019Misassembled; Misassembled; Obstruction of Flow

  IT WAS REPORTED THAT THE TECH INSERTED THE FOLEY CATHETER AND NOTED NO URINE RETURN. TO TROUBLE SHOOT, THE TECH REPORTEDLY DISCONNECTED THE DRAINAGE TUBING FROM THE CATHETER AND FOUND ONE OF THE LITTLE BLUE RUBBER SAFE SAMPLING PORTS LODGED IN THE HUB OF THE CATHETER, WHICH PREVENTED THE CATHETER FROM DRAINING. THE COMPLAINANT NOTED THAT THE TUBING DID HAVE THE SAMPLING PORT INTACT, "SO IT MUST HAVE BEEN AN EXTRA FROM THE MANUFACTURING PROCESS." THE COMPLAINANT REPORTED THAT THE CATHETER DRAINED APPROPRIATELY AFTER REMOVAL OF THE BLUE PORT.

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

  MAUDE report 9305409 ↗
• MalfunctionJul 19, 2019Misassembled; Misassembled

  IT WAS REPORTED THAT THE CAP WAS MISSING FROM THE STERILE WATER SYRINGE.

  Patient problems: No Patient Involvement

  MAUDE report 8806977 ↗
• MalfunctionJul 3, 2019Gel Leak; Gel Leak

  IT WAS REPORTED THAT THE BROWN FOREIGN MATERIAL WAS INSIDE OF THE SURESTEP FOLEY TRAY AND ON THE TIP OF THE LUBRICANT SYRINGE.

  Patient problems: No Patient Involvement

  MAUDE report 8761205 ↗
• MalfunctionJun 1, 2017Component Missing

  IT WAS REPORTED THAT THE STERILE WATER SYRINGE WAS MISSING FROM THE TRAY.

  Patient problems: No Patient Involvement

  MAUDE report 6604331 ↗