SureStep™ Foley Tray System with Bard® Lubri-Sil® Temp Sensing Foley Catheter A119216MRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741073687), received between Oct 26, 2017 and May 13, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Component Missing” (9 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-2521-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT (B)(6) HAD REPORTING ISSUES WITH LEAKING AROUND THE PENIS OF THE PATIENT WHILE USING TEMP SENSING FOLEYS. THIS WAS REPORTED BY A NURSE IN THEIR CRITICAL CARE MEDICAL UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22008588 ↗
• MalfunctionSep 16, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT DURING A FOLEY LIFECYCLE ASSESSMENT, A SURESTEP FOLEY TRAY WAS NOTED TO HAVE 2 SWAB STICKS INSTEAD OF 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20223982 ↗
• MalfunctionJan 24, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THEY HAD AN ISSUE WITH 10 CC SYRINGE OF STERILE WATER IN ONE OF THE FOLEY TRAYS. THERE WAS SOME KIND OF DEBRIS IN THE SYRINGE. PER ADDITIONAL FOLLOW UP RECEIVED VIA EMAIL ON 06FEB204, STATED THAT IT WAS NOTICED BEFORE USE, AND THEY PULLED A NEW PRODUCT FOR USE ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18569998 ↗
• MalfunctionAug 7, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE WATER SYRINGE IN FOLEY TRAY HAD MISSING CAP AND THERE WAS NO WATER IN THE SYRINGE. PER FOLLOW UP VIA EMAIL RECEIVED ON 27JUL2023, CUSTOMER STATED THERE WAS NO HARM OR INJURY. THE EMPTY SYRINGE WAS DOING UPON OPENING A PREPPING THE KIT. ONCE DISCOVERED, THE NURSE DISCARDED THE KIT AND OPENED A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469161 ↗
• MalfunctionJun 26, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THERE WERE NO IODINE SWAB STICKS IN A FOLEY TRAY THEY WERE USING DURING THE LIFECYCLE ASSESSMENT YESTERDAY AFTERNOON. THEY WERE NOT UNDER ANYTHING OR IN THE PACKAGE AT ALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17198867 ↗
• MalfunctionSep 19, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE FOLEY TRAY DID NOT CONTAIN BETADINE OR THE SYRINGE OF LUBRICANT. THE CUSTOMER ASKED IF BOTH OF THESE KITS INCLUDED THOSE ITEMS, AND THEY WERE JUST TRYING TO DETERMINE IF THERE WAS SOMETHING WRONG WITH THE KIT OR IF THEY NEEDED TO DID SOME EDUCATION ON THEIR SUBS. THE LABEL FOR EACH TRAY WAS ATTACHED, WHICH PROVIDED A DETAILED LIST OF ITEMS INCLUDED THAT A119216M CONTAINED LUBRISIL ALL SILICONE TEMP SENSING 16FR FOLEY STATLOCK CONTROL-FIT OUTLET DEVICE, DRAINAGE TUBE COLLECTION BAG (2500 ML), 3 FOAM SWABS, POVIDONE IODINE PACKET, PERI-CARE KIT (SOAP TOWELETTES & HAND SANITIZER) AND A319416AM CONTAINED BARDEX IC 16FR TEMP SENSING FOLEY STATLOCK ANTI-MICROBIAL CONTROL-FIT OUTLET DEVICE, 350ML URINE METER BACTERIOSTATIC COLLECTION BAG (2500ML), 3 FOAM SWABS, POVIDONE IODINE PACKET, PERI-CARE KIT (SOAP TOWELETTES & HAND SANITIZER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446362 ↗
• MalfunctionSep 19, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT REPRESENTATIVE GOT A REPORT THAT THE FOLEY TRAYS DID NOT CONTAIN BETADINE OR LUBRICANT SYRINGE. REPRESENTATIVE WAS TRYING TO DETERMINE IF THERE WAS SOMETHING WRONG WITH THE KIT, OR IF THEY NEED TO DO SOME EDUCATION ON THE SUBSTITUTES. REPRESENTATIVE WAS GIVEN RESPONSE THAT THE LABEL FOR EACH TRAY WAS ATTACHED WHICH PROVIDES A DETAILED LIST OF ITEMS INCLUDED AND WAS ALSO TOLD THAT A119216M CONTAINS LUBRISIL ALL SILICONE TEMPERATURE SENSING 16FR FOLEY, STATLOCK, CONTROL-FIT OUTLET DEVICE DRAINAGE TUBE COLLECTION BAG (2500 ML), 3 FOAM SWABS, POVIDONE IODINE PACKET, PERI-CARE KIT (SOAP TOWELETTES & HAND SANITIZER), A319416AM CONTAINS BARDEX INFECTION CONTROL 16FR TEMPERATURE SENSING FOLEY, STATLOCK, ANTI-MICROBIAL CONTROL-FIT OUTLET DEVICE 350ML URINE METER BACTERIOSTATIC COLLECTION BAG (2500ML), 3 FOAM SWABS, POVIDONE IODINE PACKET, PERI-CARE KIT (SOAP TOWELETTES & HAND SANITIZER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446356 ↗
• MalfunctionAug 21, 2020Short Fill; Component Missing; Short Fill

  IT WAS REPORTED THAT THE IRRIGATION SYRINGE HAD NO WATER IN IT.

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

  MAUDE report 10437976 ↗
• MalfunctionJul 15, 2020Deflation Problem; Decrease in Pressure; Device Dislodged or Dislocated; Decrease in Pressure

  IT WAS REPORTED THAT THE BALLOON FAILED TO STAY INFLATED AND FELL OUT OF THE PATIENT.

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

  MAUDE report 10275481 ↗
• MalfunctionJun 17, 2020Component Missing

  IT WAS REPORTED THAT THE FOLEY KIT DID NOT CONTAIN THE SYRINGE FILLED WITH FLUID TO INFLATE THE BALLOON.

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

  MAUDE report 10165701 ↗
• MalfunctionMar 26, 2019Misassembled; No Flow; Misassembled

  IT WAS REPORTED THAT THE DRAIN SPOUT ON THE BAG WAS NOT OPEN AS IF THE TUBE WAS NOT PATENT. THE ISSUE WAS NOTICED WHEN THE DEVICE WOULD NOT DRAIN.

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

  MAUDE report 8453840 ↗
• MalfunctionFeb 5, 2019Component Missing

  IT WAS REPORTED THAT THE SURESTEP CATHETER TRAY WAS MISSING THE IODINE SWABSTICKS, THE LUBE SYRINGE AND THE STERILE WATER SYRINGE. THE REMAINING ITEMS OF THE TRAY WERE USED WITH NO PATIENT IMPACT. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8307076 ↗
• MalfunctionJan 31, 2019Short Fill; Component Missing; Short Fill

  IT WAS REPORTED THAT THE WATER SYRINGE ONLY HAD A SMALL DROP OF LIQUID INSIDE.

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

  MAUDE report 8293945 ↗
• MalfunctionOct 26, 2017Component Missing

  IT WAS REPORTED THAT THE 10ML SYRINGE WITHIN THE FOLEY TRAY ONLY CONTAINED A FEW DROPS OF STERILE WATER. THE COMPLAINANT REPORTED THAT THE STERILE WATER HAD NOT LEAKED OUT AS NONE OF THE TRAY'S COMPONENTS WERE WET.

  Patient problems: No Information

  MAUDE report 6979867 ↗