SureStep Foley Tray System Bard Lubricath FoleyRecalls & reported problems across all models

We found 7 models of SureStep Foley Tray System Bard Lubricath Foley by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between May 19, 2017 and Dec 24, 2024 — classified as 3 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Component Missing” (9 reports).

4 FDA recall records name at least one of these models by its device identifier, 4 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

SureStep Foley Tray System Bard Lubricath Foley recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-3114-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

2. Aug 5, 2021Class IIOpen, Classified

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

   Z-2532-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

3. Aug 5, 2021Class IIOpen, Classified

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

   Z-2531-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

4. Aug 5, 2021Class IIOpen, Classified

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

   Z-2530-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported SureStep Foley Tray System Bard Lubricath Foley problems

SureStep Foley Tray System Bard Lubricath Foley models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SureStep™ Foley Tray System Bard® Lubricath Foley A800365

  CATHETER, COUDE
  2 recalls12 reports
• SureStep™ Foley Tray System Bard® Lubricath Foley A800361

  CATHETER, COUDE
  2 recalls9 reports
• SureStep™ Foley Tray System Bard® Lubricath Foley A800360

  CATHETER, COUDE
  1 recall3 reports
• SureStep™ Foley Tray System Bard® Lubricath Foley A800364

  CATHETER, COUDE
  3 reports
• SureStep™ Foley Tray System Bard® Lubricath Foley A800060

  CATHETER, COUDE
  2 reports
• SureStep™ Foley Tray System Bard® Lubricath Foley A800362

  CATHETER, COUDE
  1 report
• SureStep™ Foley Tray System Bard® Lubricath Foley A800366

  CATHETER, COUDE
  1 report

Recent SureStep Foley Tray System Bard Lubricath Foley adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A STERILE WATER PRODUCT ABOUT TO BE USED FOR A FOLEY CATHETER AND IT WAS FOUND TO BE CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21011078 ↗
• MalfunctionAug 23, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT PATIENT WAS UNABLE TO VOID POST-OP, PHYSICIAN ORDERED FOLEY CATHETER INSERTION. NURSE OPENED ONE FOLEY CATHETER KIT AND CATHETER WAS MISSING (MW5157012). NO EXTRA FOLEY CATHETER WAS AVAILABLE IN DEPARTMENT, SO ANOTHER KIT WAS OPENED. NURSES DISCOVERED THE COVERING OF THE CATHETER WAS TORN OPENED (MW5157013). NURSES DECIDED TO OPEN A THIRD KIT AND AGAIN THE COVERING OVER THE CATHETER WAS TORN (MW5157011). HOUSE SUPERVISOR WAS NOTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20047998 ↗
• MalfunctionMay 31, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON COULD NOT BE DEFLATED. THE PATIENT EXPERIENCED INCONVENIENCE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 19434079 ↗
• MalfunctionJan 19, 2024Short Fill; Short Fill

  IT WAS REPORTED THAT FOLEY CATHETER KIT DID NOT HAVE ADEQUATE SALINE IN PREFILLED SYRINGE FOR RETENTION BULB. CATHETER KIT ALSO DID NOT HAVE ORANGE STICKERS FOR CHART OR CATHETER TIME OR DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18542424 ↗
• MalfunctionJan 18, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT FOLEY CATHETER KIT DID NOT HAVE ADEQUATE SALINE IN PREFILLED SYRINGE FOR RETENTION BULB. CATHETER KIT ALSO DID NOT HAVE ORANGE STICKERS FOR CHART OR CATHETER TIME OR DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18533993 ↗
• MalfunctionAug 26, 2022Component Missing; Component Misassembled; Component Missing; Component Misassembled

  IT WAS REPORTED THAT WHEN THE SURESTEP FOLEY KIT WAS OPENED, THE 10 ML FLUSH SYRINGE INSIDE THE KIT HAD NO FLUID OR END CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15302682 ↗
• MalfunctionJul 12, 2022Short Fill; Short Fill

  IT WAS REPORTED THAT THERE WAS NO LUBE IN THE FOLEY SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14989301 ↗
• MalfunctionJul 11, 2022Short Fill; Short Fill

  IT WAS REPORTED THAT THE NURSE OPENED A 16F BARD FOLEY SURE-STEP TRAY SYSTEM AND FOUND THAT THE PREFILLED SYRINGE PARTIALLY EMPTY AND MISSING THE CAP .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14978557 ↗
• MalfunctionJul 8, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE NURSE OPENED A 16F BARD FOLEY SURE-STEP TRAY SYSTEM AND FOUND THAT THE PREFILLED SYRINGE PARTIALLY EMPTY AND MISSING THE CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14962245 ↗
• MalfunctionDec 14, 2021Illegible Information; Illegible Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ALLERGIC REACTIONS WITH THE USE OF LATEX URINARY CATHETERS. IT WAS STATED THAT THE PATIENT REQUIRED SURGICAL AIRWAY DUE TO ALLERGIC REACTIONS. THE CUSTOMER REPORTED THAT UPON REVIEWING THEIR CURRENT MATERIALS, IT WAS APPARENT THAT THE LABELLING OF FOLEY KITS AND THE INDIVIDUAL CATHETERS, WITH RESPECT TO LATEX-STATUS HAD NOT BEEN AS EFFECTIVE AS THEY WISHED. IT WAS STATED THAT THE LATEX CAUTION LABEL WAS NOT EASILY VISIBLE, AND IT COULD BE DIFFICULT TO TELL THE DIFFERENCE BETWEEN LATEX AND LATEX-FREE KITS. ALSO STATED THAT THE INDIVIDUAL URINARY CATHETERS MIGHT ALSO CONTAIN LATEX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13004283 ↗
• MalfunctionSep 30, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE SURESTEP FOLEY TRAY SYSTEM HAD ONLY 2 BETADINE SWABS WERE PRESENT INSTEAD OF 3 SWABS. THE CUSTOMER ALSO REPORTED THAT ONE SWAB WAS TURNED TO FACE THE WRONG WAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12555762 ↗
• MalfunctionMar 5, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE FOLEY TRAY DID NOT HAVE A STATLOCK SECUREMENT DEVICE AS IT WAS SUPPOSED TO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11423466 ↗
• MalfunctionMar 1, 2021Inadequate Instructions for Healthcare Professional; Illegible Information; Inadequate Instructions for Healthcare Professional; Illegible Information

  IT WAS REPORTED THAT THE PRODUCT DID NOT VISIBLY STATE THAT IT WAS MADE OF LATEX. THIS HAD LED TO CONFUSION AND INCORRECT CATHETER PLACEMENT. HENCE THE LATEX WARNING WAS INSIDE OF THE PACKAGING AND THE CUSTOMER PREFERRED TO BE ON THE EXTERIOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396364 ↗
• MalfunctionJan 28, 2021Deflation Problem; Difficult to Remove

  UPON COMPLETION OF MEDICATION REGIMEN, AN ATTEMPT WAS MADE TO REMOVE PATIENT'S FOLEY CATHETER. ONLY 6 CC'S WERE ABLE TO BE REMOVED FROM THE FOLEY BALLOON. FOLEY CONTINUES TO FUNCTION AND DRAIN URINE. BALLOON INFLATION LINE CUT, BUT NO AIR WOULD COME OUT OF BALLOON. BALLOON ULTIMATELY PUNCTURED BY PROVIDER AND DEFLATED.

  Patient problems: Insufficient Information

  MAUDE report 11243233 ↗
• MalfunctionFeb 5, 2020Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE GREEN TUBE WOULD NOT DRAIN PROPERLY. PER FOLLOW UP ON 20JAN2020, THE TUBING WAS BENT AND GLUED TO THE DRAIN BAG AND WAS NOT ABLE TO BE DRAIN.

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

  MAUDE report 9671916 ↗

Other C. R. Bard, Inc. products

• Bardex I.C. Foley Catheter26 models · 3,607 reports
• Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
• Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
• Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
• Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
• Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
• PureWick Female External Catheter5 models · 1,184 reports
• Bardex All-Silicone Foley Catheter12 models · 1,170 reports