SureStep Foley Tray System BardLubricath Foley CatheterRecalls & reported problems across all models

We found 2 models of SureStep Foley Tray System BardLubricath Foley Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Oct 1, 2018 and Oct 1, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Misassembled” (1 report).

2 FDA recall records name at least one of these models by its device 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. 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 BardLubricath Foley Catheter 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-2535-2021 · Root cause: Packaging change control · Recall details · FDA record ↗

Most reported SureStep Foley Tray System BardLubricath Foley Catheter problems

SureStep Foley Tray System BardLubricath Foley Catheter models

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

• SureStep™ Foley Tray System Bard®Lubricath® Foley Catheter A902616

  CATHETER, COUDE
  2 recalls1 report
• SureStep™ Foley Tray System Bard®Lubricath® Foley Catheter A902618

  CATHETER, COUDE
  1 recall0 reports

Recent SureStep Foley Tray System BardLubricath Foley Catheter adverse event reports

The 1 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2018Misassembled; Appropriate Device Problem Term/Code Not Available; Misassembled

  IT WAS REPORTED THAT THE LATEX WARNING WAS COVERED BY THE FLAP ON THE END OF THE PACKAGING ON THE FOLEY TRAY. COMPLAINANT REPORTED THIS RESULTED IN THE CATHETER BEING USED ON A PATIENT WITH LATEX SENSITIVITY AND ALLEGEDLY CAUSED THE PATIENT TO HAVE AN ALLERGIC REACTION. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hypersensitivity/Allergic reaction; Reaction

  MAUDE report 7923897 ↗

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