SureStep™ Foley Tray System Lubri-Sil® IC Complete Care® A303416ARecalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00801741073823), received between Jun 29, 2017 and Jun 25, 2026 — classified as 1 injury, 44 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (6 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-3115-2026 · 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-2540-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD BALLOON THAT COULD NOT BE DEFLATED, AND PHYSICIANS HAD TO REMOVE CATHETER WHILE BALLOON WAS STILL INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25622649 ↗
• MalfunctionSep 17, 2025Gel Leak; Gel Leak

  IT WAS REPORTED THAT FOLEY TRAY WAS DAMAGED, INTERNAL LEAK. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 16SEP2025, IT WAS REPORTED THAT CATH TRAY - (B)(6) - TRAY CATH 16 FR KIT INDWELL LAT FREE 5 CC BALL ¿ WAS DELIVERED BY OUR VENDOR. INVENTORY CONTROL STAFF DISCOVERED THE TRAY WAS DAMAGED (SEE ATTACHED PHOTO). THERE WERE NO OBVIOUS SIGNS OF DAMAGE TO THE EXTERIOR OF THE PACKAGING, AND THE OUTER POLY WRAP WAS STILL INTACT. THE TRAY WAS REMOVED FROM THE VENDOR¿S DELIVERY TOTE AND ISOLATED AGAINST ACCIDENTAL USE. LEADERSHIP WAS NOTIFIED TO INVESTIGATE, AND A REPORT WAS SUBMITTED TO THE VENDOR. NO OTHER ACTIONS WERE TAKEN TO DETERMINE THE CAUSE OF THE LEAKAGE TO THE TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23073008 ↗
• MalfunctionJul 15, 2025Material Puncture/Hole; Device Dislodged or Dislocated; Unintended Deflation

  THE FOLEY CATHETER WAS REPLACED VIA RN AT 1100. UPON TURNING PATIENT, AT APPROXIMATELY 1150 AM, THE CATHETER TUBE WAS PULLING OUT OF PATIENT AND THE BALLOON WAS DEFLATED. TWO NURSES EXAMINED THE CATHETER BALLOON FURTHER AND FOUND A HOLE IN THE DEVICE BALLOON. PATIENT WAS ASSESSED AND IT WAS UNKNOWN IF ANY INJURY WAS CAUSED TO THE PATIENT, IF SO, WAS MINOR.

  Patient problems: Insufficient Information

  MAUDE report 22506301 ↗
• MalfunctionJun 4, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THERE WAS A KINK IN THE TUBING OF THE FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140762 ↗
• MalfunctionApr 23, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT THEY HAD A FOLEY INSERTION KIT AT (B)(6) MISSING THE SALINE SYRINGE TO INFLATE THE BALLOON. THEY WERE NOT SURE IF ALL OF THIS LOT WAS IMPACTED BUT WANTED YOU TO BE AWARE. BARD 16 FR FOLEY CATHETER KIT LOT # NGJW3312 CAME WITHOUT A SALINE FLUSH FOR INFLATION OF BALLOON. KIT HAD LUBE SYRINGE X2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21890308 ↗
• MalfunctionMar 20, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE STERILE WATER SYRINGE 10 CC, WITHIN A FOLEY TRAY WAS FOUND TO BE UNCAPPED AND DRAINED OF LIQUID UPON OPENING OF THE KIT. THE KIT WAS NOT USED ON A PATIENT. NO PATIENT INJURY WAS REPORTED. NO MEDICAL TREATMENT WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652702 ↗
• InjuryJan 9, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CLINICIAN WAS CHANGING OUT THE GLOVES FROM THE KIT AND THE PATIENT WAS EXCRETING BLOOD IN URINE. WHEN THE FOLEY WAS CHANGED OUT AND THE REGISTERED NURSE REMOVED THE GLOVES THERE WAS THE PRESENCE OF THE BLOOD AND URINE ON THEIR HANDS. THEY CHECKED TO SEE IF THERE WERE ANY TEARS OR HOLES BUT COULD NOT FIND ANYTHING. REGISTERED NURSE DID NOT REQUIRE ANY DIAGNOSTIC TESTING. THEY JUST WASHED THEIR HANDS, AND THE MATERIAL MANAGEMENT ALSO STATED THAT THERE HAVE BEEN OTHER EVENTS WHICH HAD OCCURRED SIMILAR TO THIS EVENT WITHIN THE FACILITY AND THE GLOVES HAVE BEEN PULLED UNTIL FURTHER REVIEW. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Exposure to Body Fluids; Hematuria

  MAUDE report 21113683 ↗
• MalfunctionJan 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT UPON OPENING THE FOLEY TRAY TO THE STERILE FIELD, THEY NOTICED A HAIR WAS WRAPPED AROUND THE FOLEY CATHETER AND ON THE BAG OF THE FOLEY. THEY DID NOT GRAB THE FOLEY OUT OF THE TRAY AND IT WAS NOT TOUCHED. THEY SEQUESTERED THE ITEM AND TRAY AND WRAPPED IT BACK INTO ITS ORIGINAL PACKAGING AND IT WAS SHIPPED ON 11DEC2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103366 ↗
• MalfunctionJan 6, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE CUSTOMER HAD 3 DIFFERENT ISSUES WITH THE FOLEY TRAY ALL WITH SAME LOT #. THE FIRST ISSUE WAS THERE WAS A SMALL BUG (GNAT) INSIDE THE PACKAGING, SECOND ISSUE STATED THERE WAS AN ORANGE THREAD INSIDE THE PACKAGING AND THE LAST ISSUE STATED THERE WAS A HOLE ON INSIDE WRAPPER. PER FOLLOW UP VIA EMAIL ON 02JAN2025, IT WAS REPORTED THAT PK7645844 WAS THE ONLY NUMBER OUTSIDE THE PACKAGING TO IDENTIFY THE PRODUCT. THE EXACT DATE OF OCCURRENCE WAS NOT NOTED. THE DEFECT WAS NOTICED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079071 ↗
• MalfunctionJan 6, 2025Device 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 THE CUSTOMER HAD 3 DIFFERENT ISSUES WITH THE FOLEY TRAY ALL WITH SAME LOT#. THE FIRST ISSUE WAS THERE WAS A SMALL BUG (GNAT) INSIDE THE PACKAGING, SECOND ISSUE STATED THERE WAS AN ORANGE THREAD INSIDE THE PACKAGING AND THE LAST ISSUE STATED THERE WAS A HOLE ON INSIDE WRAPPER. PER FOLLOW UP VIA EMAIL ON 02JAN2025, IT WAS REPORTED THAT PK7645844 WAS THE ONLY NUMBER OUTSIDE THE PACKAGING TO IDENTIFY THE PRODUCT. THE EXACT DATE OF OCCURRENCE WAS NOT NOTED. THE DEFECT WAS NOTICED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078794 ↗
• MalfunctionJan 3, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT 3 FOAM SWABS WERE MISSING FROM FOLEY TRAYS WHEN OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067483 ↗
• MalfunctionOct 7, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE ON ANOTHER FOLEY CATHETER AND PROVIDED LOT#NGJP3214. PER ADDITIONAL INFORMATION RECEIVED ON 18SEP2024, IT WAS REPORTED THAT THEY NOTED THE KIT WAS MISSING A FLUSH. THEY CLARIFIED THAT THE FLUSH WAS THE 10-CC SYRINGE OF STERILE WATER THAT WAS MISSING. PER ADDITIONAL INFORMATION RECEIVED ON 31OCT2024, IT WAS REPORTED THAT THE NEEDED COMPONENT WAS OBTAINED, AND THE CATHETER WAS UTILIZED. A MISSING FLUSH WAS REPORTED BUT THIS PRODUCT HAD NO FLUSH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384917 ↗
• MalfunctionSep 12, 2024

  CIRCULATING RN INSERTED 16 FR FOLEY CATHETER USING STERILE TECHNIQUE, WITHOUT RESISTANCE. 10CC BALLOON INFLATED WITH 10 ML STERILE WATER. RN NOTED BALLOON PORT TO BE SLOWLY AND STEADILY LEAKING WATER AFTER REMOVAL OF SYRINGE. BALLOON DEFLATED (9 ML WATER REMOVED) AND FOLEY CATHETER REMOVED. NEW 16 FR FOLEY PACKAGE OPENED AND INSERTED. NO LEAKING NOTED UPON BALLOON INFLATION WITH STERILE WATER. LEAKING BALLOON PORT--SURESTEP FOLEY TRAY SYSTEM (REF. A303416A) (POSSIBLE LOT #PK7662511 OR #PK7645844) NO KNOWN INJURY TO PATIENT OCCURRED. MALFUNCTIONING FOLEY CATHETER WAS REPLACED IMMEDIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199322 ↗
• MalfunctionAug 28, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE NURSE WAS TRYING TO PLACE A FOLEY ON A PATIENT. THE SYRINGE WAS TYPICALLY FILLED TO 10ML WITH A CAP TO IT. THIS CONTAINER HAD A SYRINGE WITH NO CAP, AND IT ONLY HAD 1 ML IN IT. PER FOLLOW UP RESPONSE RECEIVED VIA EMAIL ON 22AUG2024, CUSTOMER STATED THAT THIS DEFECT WAS NOTICED PRIOR TO PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20085404 ↗
• MalfunctionJul 30, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE FOLEY INSERTION KIT WAS OPENED, INSERTION PROCESS WAS STARTED UNTIL THIS REGISTERED NURSE NOTICED THAT THE 10ML SYRINGE FILLED WITH STERILE WATER WAS 1/2 EMPTY AND THE CAP WAS MISSING. THIS REGISTERED NURSE STOPPED PROCEDURE AND KIT WAS DISCARDED AND A NEW FOLEY INSERTION KIT WAS USED FOR PATIENT CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19861274 ↗
• MalfunctionMay 15, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THEY HAD AN ISSUE WITH BARD ITEM THAT WE PURCHASED FROM OWENS AND MINORS. THIS FOLEY KIT HAS A KINK IN THE CORD WHICH COULD CAUSE PATIENT HARM. THEY HAVE CONFIRMED THAT 3 KITS WITH THIS LOT# NGJP0115 HAD A KINK IN THE HOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19320471 ↗
• MalfunctionMay 13, 2024Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE FOLEY KIT HAD A KINK IN THE CORD WHICH COULD CAUSE PATIENT HARM. THEY HAVE CONFIRMED THAT 3 KITS WITH THIS LOT# NGJP0115 HAD A KINK IN THE HOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296667 ↗
• MalfunctionMay 10, 2024Short Fill; Short Fill

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD BROWN TIP (NORMALLY TRANSLUCENT) AND A MISSING CAP ON THE SYRINGE TO INFLATE BALLOON. MULTIPLE ISSUES WITH THIS ACCOUNT AND THIS UNIT. PER CUSTOMER RESPONSE VIA EMAIL ON 23APR2024, IT WAS REPORTED THAT THE PRODUCT WAS USED ON A PATIENT, BUT THE PATIENT WAS NOT HARMED. CUSTOMER OPENED FOLEY CATHETER SET AND FOUND THAT THE TIP OF THE FOLEY CATHETER WAS DISCOLORED (BROWNISH) AND THE SYRINGE TO INFLATE THE BALLOON WAS EMPTY AND MISSING THE CAP. CATHETER SET DISPOSED OF PRIOR TO PLACEMENT, PACKAGING SEALED AND DELIVERED TO MANAGEMENT. PER CUSTOMER RESPONSE VIA EMAIL ON 22MAY2024, IT WAS CONFIRMED THAT THE MISSING CAP CAUSED THE CONTENTS TO LEAK OUT, RESULTING WITH AN EMPTY SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19287081 ↗
• MalfunctionMay 3, 2024Component Missing; Component Misassembled; Component Missing; Component Misassembled

  IT WAS REPORTED THAT THE FOLEY CATHETER HAD BROWN TIP (NORMALLY TRANSLUCENT) AND A MISSING CAP ON THE SYRINGE TO INFLATE BALLON. MULTIPLE ISSUES WITH THIS ACCOUNT AND THIS UNIT. PER CUSTOMER RESPONSE VIA EMAIL ON 23APR2024, IT WAS REPORTED THAT THE PRODUCT WAS USED ON A PATIENT, BUT THE PATIENT WAS NOT HARMED. CUSTOMER OPENED FOLEY CATHETER SET AND FOUND THAT THE TIP OF THE FOLEY CATHETER WAS DISCOLORED (BROWNISH) AND THE SYRINGE TO INFLATE THE BALLOON WAS EMPTY AND MISSING THE CAP. CATHETER SET DISPOSED OF PRIOR TO PLACEMENT, PACKAGING SEALED AND DELIVERED TO MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19237863 ↗
• MalfunctionMay 2, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THE FOLEY CATHETER KIT DID NOT CONTAIN CATHETER, ONLY DRAINAGE COLLECTION BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228548 ↗
• MalfunctionApr 12, 2024

  FOLEY CATHETER KIT DID NOT CONTAIN CATHETER, ONLY DRAINAGE COLLECTION BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095339 ↗
• MalfunctionMar 8, 2024

  16 FRENCH FOLEY CATHETER TO PLACE AND WHEN I OPENED IT UP, I NOTICED THE TIP OF THE CATHETER WAS SUPER KINKED, UNABLE TO BE USED. I WAS TOLD TO CALL REGARDING DEFECTIVE ITEM. ITEM NUMBER IS 1758SI16NGHV2549. 16 FRENCH 10 ML FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18865231 ↗
• MalfunctionSep 19, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE FOLEY CATHETER KIT DID NOT HAVE BETADINE IN THE KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17772426 ↗
• MalfunctionSep 7, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHILE SETTING UP FOLEY TRAY PRIOR TO INSERTION, IT WAS NOTED THAT THERE WAS NO TIP ON THE END OF THE CATHETER, JUST AN OPEN ROUGH END. A NEW CATHETER WAS OBTAINED AND USED WITH THE FOLEY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17699566 ↗
• MalfunctionSep 1, 2022Gel Leak; Gel Leak

  IT WAS REPORTED THAT SALINE SYRINGE WHICH SUPPOSED TO CONTAIN SALINE WAS EMPTY AND THE PLUNGER WAS MISSING. IT WAS ALSO STATED THAT THERE WAS NO LUBRICANT IN THE LUBRICANT SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15335672 ↗