SureStep™ Foley Tray System Lubri-Sil® IC Complete Care® A319516AMRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00801741073892), received between Nov 2, 2017 and Feb 19, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Component Missing” (4 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-2538-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Erratic or Intermittent Display

  IT WAS REPORTED BY CUSTOMER THAT THE TRAYS ARE NOT PROVIDING ACCURATE TEMPERATURE READINGS AND HAVE ARRIVED MISSING COMPONENTS, INCLUDING SYRINGES AND STERILE WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388326 ↗
• MalfunctionJan 23, 2026Component Misassembled

  IT WAS REPORTED THAT THE TRAY CONTAINING THE CATHETER FOLEY ¿ COMPLETE CARE WITH TEMPERATURE SENSOR, SILICONE 16FR, AND A 350 ML URINE METER WAS USED ON THE PATIENT. THE TRAY STATED THAT IT HAD STERILE WATER IN THE SYRINGE; HOWEVER, THE SYRINGE WAS PRESENT WITHOUT A CAP AND DID NOT CONTAIN ANY STERILE WATER AND IT WAS EMPTY. ANOTHER STAFF MEMBER HAD TO GO AND GET STERILE WATER, WHICH DELAYED THE PROCEDURE.

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

  MAUDE report 24171733 ↗
• MalfunctionJul 29, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT IN FOLEY TRAY, THE SYRINGE WITH LUBE AND SYRINGE WITH STERILE WATER WAS MISSING. CUSTOMER EMAIL RESPONSE RECEIVED ON 25SEP2025. IT WAS REPORTED THAT THE PRODUCT WAS NOT RETAINED AND THE LOT NGKR2059 WAS CONFIRMED AS THE AFFECTED LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22645413 ↗
• MalfunctionApr 2, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS FOREIGN OBJECT IN FOLEY TRAY. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 24MAR2025, IT WAS REPORTED THAT THE OPEN TRAY AND FOUND FOREIGN OBJECT IN TRAY DID NOT USE ON PATIENT DISCARDED AND NEW TRAY OBTAINED TO INSERT CATHETER. REPORTED BY CHARGE NURSE TO VALUE ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751848 ↗
• MalfunctionFeb 12, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A PIECE OF CARDBOARD IN THE STERILE WATER SYRINGE. NO IMPACT THEY WERE USING THE FOLEY TRAY-SYRINGE ON ANATOMICAL MODALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364633 ↗
• MalfunctionJan 31, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THE CUSTOMER STATED THEY OPENED UP PRODUCT A319516AM, WHICH LISTS IT HAD A MOLEX CONNECTOR TEMP FOLEY, BUT THE WRONG FOLEY TRAY-SYRINGE WAS INSIDE THE KIT WHICH HAD A MONOPLUG CONNECTOR INSTEAD. NORMALLY THAT MONOPLUG WAS USED INSIDE THE A319516A SERIES FOLEY KITS. THEY WERE NOT SURE HOW A MONO-PLUG FROM A319516A MADE IT WAS WAY INTO A MOLEX FOLEY KIT A319516AM. THEY ASKED THE CUSTOMER TO DOUBLE CHECK IF THEIR FOLEY KIT WAS A319516AM AND NOT A319516A, AND THEY CONFIRMED WITH A PICTURE THAT IT WAS A319516AM. LONG STORY SHORT THEY SAID WRONG FOLEY WAS PUT INSIDE THE FOLEY KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282283 ↗
• MalfunctionOct 4, 2024Short Fill; Short Fill

  IT WAS REPORTED THAT DOCTOR ORDERED TO USE A THERMISTOR FOLEY. WRITER TOOK A KIT AND INSERTED A NEW ONE. THE KIT HAD HALF-FILLED SYRINGE OF THE STERILE WATER SUPPOSEDLY TO KEEP THE FOLEY IN PLACE. THIS WAS UNUSUAL FOR THE KIT; THE BALLOON NEEDED TO HAVE 10ML SYRINGE. IT WAS EXPECTED TO THE KIT TO HAVE ONE. WRITER KEPT THE FOLEY IN PLACE AND USED A 10ML STERILE SALINE SOLUTION INSTEAD. PATIENT DID NOT HAD APPARENT HARM BUT FELT INCONVENIENT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 20371795 ↗
• MalfunctionAug 23, 2024Short Fill; Component Misassembled; Short Fill; Component Misassembled

  IT WAS REPORTED THAT OPERATING ROOM HAS FOUND 3 FOLEY TRAYS WERE THE 10CC SYRINGE OF STERILE WATER HAD NO STERILE WATER IN IT. THEY HAD ONE LABEL, BUT IT DOES NOT HAVE A LOT # ON IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20049619 ↗
• MalfunctionJun 4, 2024Short Fill; Short Fill

  IT WAS REPORTED THAT FOLEY CATHETER HAD ONLY 1 CC SALINE IN SYRINGE INSTEAD OF 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459770 ↗
• MalfunctionJul 10, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE THEY FOUND A HAIR IN THE PLUNGER OF GEL IN FOLEY TRAY. PER FOLLOW UP VIA EMAIL ON 26JUN2023, IT WAS STATED THAT THE CUSTOMER HAD THE PRODUCT, TAPED THE HAIR TO THE LABEL BUT IT WAS ORIGINALLY IN THE SYRINGE OF GEL. ALSO STATED THAT IT DID NOT AFFECT THE PATIENT, IT WAS FOUND PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17288718 ↗
• MalfunctionJan 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAK FROM THE FOLEY TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16174606 ↗
• MalfunctionSep 12, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THERE WAS NO CATHETER IN FOLEY TRAY THAT CONNECTED TO DRAINAGE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15401366 ↗
• MalfunctionJul 27, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT WHEN OPENED THE TEMPERATURE SENSING FOLEY CATHETER KIT THERE WAS NO STERILE WATER SYRINGE IN KIT FOR INFLATING BALLOON, INSTEAD 2 SYRINGES OF LUBRICATION PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15111670 ↗
• MalfunctionJun 9, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT NURSE NOTICED THE SYRINGE IN FOLEY KIT HAD A SMALL AMOUNT OF SOME ORANGE TYPE OF GEL IN THE END OF THE SYRINGE WHEN THEY WERE GETTING THE KIT SET UP TO PUT THE FOLEY IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11966381 ↗
• MalfunctionMay 26, 2021Leak/Splash; Material Puncture/Hole

  A #16 FRENCH BARD TEMP SENSOR FOLEY WAS PLACED IN THE OPERATING ROOM. THE NEXT DAY, A BAG WAS FOUND TO HAVE A HOLE IN THE DRAINAGE BAG LEAKING ONTO THE FLOOR. BAG WAS CHANGED USING ASEPTIC TECHNIQUE WITHOUT FURTHER INCIDENT.

  Patient problems: Insufficient Information

  MAUDE report 11884938 ↗
• MalfunctionSep 25, 2020Difficult to Open or Close

  IT WAS REPORTED THAT CATHETER DID NOT ALLOW STATLOCK TO CLOSE BASED ON THE WEBBING/BIFURCATION ON THE ITEM AS PER THE FOLLOW-UP RECEIVED ON 11SEP2020 ,THE COMPLAINANT WAS USING A 2 WAY STATLOCKS BUT LEAVING THE TEMP PROBE OUT OF THE STATLOCKS. THEY CHOSE TO STOCK EXTRA 2 WAY STATLOCKS HERE BUT NOT EXTRA 3 WAY. THEY DID NOT HAVE THE PACKAGING BUT WILL TRY TO GET AHOLD OF ONE IF POSSIBLE. AS PER THE FOLLOW-UP RECEIVED ON 14SEP2020, THE NURSES REPORTED THAT THEY HAD ISSUES WITH STATLOCKS THAT WERE IN THE KIT AND ALSO WITH THE ONE THAT WERE NOT INCLUDED IN THE KIT WITH THE CATHETER.

  Patient problems: Insufficient Information; No Consequences Or Impact To Patient

  MAUDE report 10587463 ↗
• MalfunctionMar 20, 2020Inflation Problem

  FOLEY CATHETER INSERTED, BALLOON INFLATED, EVENTUALLY SLID OUT DUE TO BALLOON NOT REMAINING INFLATED. INSERTED SECOND FOLEY CATHETER, BALLOON INFLATED, THIS CATHETER EVENTUALLY BACKED OUT AS WELL, BALLOON NOT INFLATED. THIRD CATHETER PLACED BALLOON INFLATED, SUCCESSFUL, NOT BACKING OUT. THE FAILED CATHETERS WERE TESTED AND SHOWED DEFECTIVE BALLOONS WITH OBVIOUS LEAKS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9859691 ↗
• MalfunctionJan 27, 2020Component Missing

  IT WAS REPORTED THAT THE IODINE WAS MISSING FROM 2 TRAYS.

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

  MAUDE report 9633186 ↗
• MalfunctionDec 10, 2018Fluid/Blood Leak

  DURING SURGERY, THE RELIEF VALVE ON THE FOLEY TUBING LEAKED URINE. THIS HAS HAPPENED SEVERAL TIMES. THIS TIME WE TRACKED A LOT#NGCVO245, REFERENCE# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8145998 ↗
• MalfunctionNov 30, 2018Misassembled; Misassembled; Fitting Problem

  IT WAS REPORTED THAT THE SURESTEP FOLEY TRAY INCLUDED STATLOCK REF # FOL0102 INSTEAD OF REF # FOL0105. AS A RESULT, THE CATHETER FROM THE TRAY WAS UNABLE TO FIT INSIDE OF THE STATLOCK PROVIDED. THE CATHETER HAD TO BE TAPED TO THE STATLOCK IN ORDER FOR IT TO ADHERE.

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

  MAUDE report 8120692 ↗
• MalfunctionOct 3, 2018Leak/Splash

  IT WAS REPORTED THAT THE PORT LEAKED UNDER THE PLASTIC MEASURING DEVICE AT THE SEAM, WHERE IT CONNECTS TO THE BAG. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7931120 ↗
• MalfunctionApr 23, 2018Component Missing; Component Missing

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS MISSING FROM THE SURESTEP FOLEY TRAY SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7452881 ↗
• MalfunctionNov 2, 2017Leak/Splash

  IT WAS REPORTED THAT THE PVI LEAKED IN THE TRAY PRIOR TO USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6995563 ↗