SureStep™ Foley Tray System Bardex® I.C. Complete Care Foley Catheter A319416AMRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741073861), received between May 18, 2017 and Nov 4, 2025 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Component Missing” (7 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-3116-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 9, 2024Class IIOpen, Classified

   Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.

   Z-2154-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

3. Aug 5, 2021Class IIOpen, Classified

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

   Z-2527-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Component Missing; Component Misassembled; Component Missing; Component Misassembled

  IT WAS REPORTED THAT NEW FOLEY OPENED WITHOUT DRAIN TUBE AND CLAMP PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23471907 ↗
• MalfunctionOct 27, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT ONE OF THE GAUZE IN THE FOLEY TRAY LOOKS TO BE DIRTY OR LOOKED BURNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390516 ↗
• MalfunctionSep 17, 2024Component Missing; Component Misassembled; Component Missing; Component Misassembled

  IT WAS REPORTED THAT DURING INSERTION, WHEN THE NURSE TRIED TO INFLATE THE SURESTEP TEMPERATURE CATHETER, THE SYRINGE HAD NO LID AND HAD 0.5ML OF STERILE WATER IN IT. THE ISSUE WAS DETECTED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236118 ↗
• 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 15446047 ↗
• 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 15445934 ↗
• MalfunctionSep 16, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THERE WAS A SHORTAGE OF NOT HAVING ORANGE LABELS IN FOLEY KITS TO PLACE ON THE BAGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437804 ↗
• MalfunctionJun 27, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE CUSTOMER PULLED A FOLEY KIT FOR A SURGICAL CASE AND NOTICED THAT THE PORT WAS EXPOSED TO THE OUTSIDE OF THE STERILE WRAP AND DID NOT USE THE KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14830483 ↗
• MalfunctionMar 23, 2021Melted; Physical Resistance/Sticking; Melted; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE TWO FOLEY CATHETER TRAYS (A319416AM) ARE DEFECTIVE. THE CATHETERS HAVE EITHER GLUE OR ARE MELTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11556576 ↗
• MalfunctionAug 9, 2019Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE DRAIN BAG HAD TO BE MANIPULATED IN ORDER FOR URINE TO FLOW. THE PATIENTS WERE RETAINING URINE IN THEIR BLADDERS.

  Patient problems: Urinary Retention

  MAUDE report 8879979 ↗
• MalfunctionAug 5, 2019Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE TUBING ON THE DRAIN BAG KINKS AT THE TOP OF THE URIMETER IMMEDIATELY UPON PLACEMENT. THE COMPLAINANT NOTED THAT URINE DOES NOT DRAIN THROUGH THE DEVICE WHEN THE TUBING KINKS.

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

  MAUDE report 8861750 ↗
• MalfunctionMar 7, 2019Misassembled; Defective Component; Positioning Problem; Misassembled

  IT WAS REPORTED THAT THE CATHETER INSIDE OF THE SURESTEP FOLEY TRAY WAS FOUND OUTSIDE OF THE PLASTIC COVER, AND ON TOP OF THE STERILE FIELD WHEN THE TRAY WAS OPENED.

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

  MAUDE report 8401552 ↗
• MalfunctionJan 3, 2019Component Missing

  IT WAS REPORTED THAT THE LUBRICATING JELLY WAS MISSING FROM THE FOLEY TRAY. THE CUSTOMER WAS UNABLE TO USE THE TRAY AND REPLACED THE PRODUCT.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 8211914 ↗
• MalfunctionDec 11, 2018Component Missing

  IT WAS REPORTED THE SYRINGE WAS MISSING FROM THE INSIDE OF THE FOLEY TRAY. NO PATIENT INTERVENTION WAS REPORTED.

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

  MAUDE report 8150287 ↗
• MalfunctionOct 8, 2018Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A STICKY RESIDUE WITHIN THE TIP OF THE CATHETER.

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

  MAUDE report 7945346 ↗
• MalfunctionMay 31, 2017Kinked

  IT WAS REPORTED THAT THE TUBING THAT CONNECTS TO THE URIMETER KINKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6602890 ↗
• MalfunctionMay 21, 2017Kinked

  IT WAS REPORTED THAT A KINK WAS IDENTIFIED NEAR THE URINE METER. THE PATIENT ALLEGEDLY COMPLAINED OF HAVING AN URGE TO URINATE, ALTHOUGH THE CATHETER WAS IN SITU. THE DEVICE WAS MANIPULATED AND NOT REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6580793 ↗
• MalfunctionMay 18, 2017Kinked

  IT WAS REPORTED THAT THE TUBING ALLEGEDLY KINKED NEAR THE URINE METER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6577048 ↗
• InjuryMay 18, 2017Fluid/Blood Leak; Kinked

  IT WAS REPORTED THAT THE TUBING OF THE DRAINAGE BAG WAS KINKED AT THE URINE METER. AS A RESULT, URINE LEAKED AROUND THE MEATUS. AN ULTRA SOUND WAS PERFORMED TO DETERMINE THE CAUSE OF THE LEAK, AS THE PATIENT WAS SEDATED. THE ULTRASOUND CONCLUDED THAT THE PATIENT'S BLADDER WAS DISTENDED. THE CATHETER WAS REPLACED AND NO FURTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Abdominal Distention

  MAUDE report 6576981 ↗