SureStep Intermittent Catheter TrayRecalls & reported problems across all models

We found 14 models of SureStep Intermittent Catheter Tray by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 104 adverse event reports in the FDA's MAUDE database, received between Jul 7, 2021 and Aug 4, 2026 — classified as 11 injuries, 93 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (18 reports).

5 FDA recall records name at least one of these models by its device 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. 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 Intermittent Catheter Tray 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, 2026Open, Classified

   Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

   Z-3118-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jun 25, 2026Open, Classified

   Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

   Z-3117-2026 · Root cause: Under Investigation by firm · names 12 of these models · Recall details · FDA record ↗

3. Jun 25, 2026Open, 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 · Recall details · FDA record ↗

4. Jan 27, 2022Terminated

   There is a potential to leak from the catheter where it connects to the drain bag

   Z-0667-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. Jan 27, 2022Terminated

   There is a potential to leak from the catheter where it connects to the drain bag

   Z-0666-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported SureStep Intermittent Catheter Tray problems

SureStep Intermittent Catheter Tray models

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

• SureStep Intermittent Catheter Tray INTS14C

  CATHETER, UROLOGICAL
  2 recalls4 reports
• SureStep Intermittent Catheter Tray INTS16C

  CATHETER, UROLOGICAL
  2 recalls2 reports
• SureStep Intermittent Catheter Tray INTP14

  CATHETER, UROLOGICAL
  1 recall44 reports
• SureStep Intermittent Catheter Tray INTS14

  CATHETER, UROLOGICAL
  1 recall31 reports
• SureStep Intermittent Catheter Tray INTL15

  CATHETER, UROLOGICAL
  1 recall9 reports
• SureStep Intermittent Catheter Tray INTS16

  CATHETER, UROLOGICAL
  1 recall5 reports
• SureStep Intermittent Catheter Tray INTP16

  CATHETER, UROLOGICAL
  1 recall5 reports
• SureStep Intermittent Catheter Tray INTL14

  CATHETER, UROLOGICAL
  1 recall2 reports
• SureStep Intermittent Catheter Tray PEDINTS06

  CATHETER, UROLOGICAL
  1 recall1 report
• SureStep Intermittent Catheter Tray INTAAI

  Catheter care tray
  1 recall1 report
• SureStep Intermittent Catheter Tray INTL16

  CATHETER, UROLOGICAL
  1 recall0 reports
• SureStep Intermittent Catheter Tray INTL16C

  CATHETER, COUDE
  1 recall0 reports
• SureStep Intermittent Catheter Tray PEDINTS08

  CATHETER, UROLOGICAL
  1 recall0 reports
• SureStep Intermittent Catheter Tray PEDINTS10

  CATHETER, UROLOGICAL
  1 recall0 reports

Recent SureStep Intermittent Catheter Tray adverse event reports

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

• InjuryAug 4, 2026Disconnection

  It was reported that during a straight in and out catheterization procedure, the coude catheter tubing became disconnected from the collection bag. The device was reported to be intact prior to insertion. Urine initially drained into the collection bag, however, while the user was holding the coude tubing, the tubing separated from the bag and urine drainage stopped. Approximately 300 mL of urine had collected in the bag at the time of disconnection. A subsequent bladder scan indicated greater than 600 mL of urine remained in the patient's bladder. Photographs of the damaged tubing were reportedly taken. No patient injury was reported.

  Patient problems: Urinary Retention

  MAUDE report 50131780 ↗
• MalfunctionJan 30, 2026Component Misassembled

  IT WAS REPORTED THAT THE SURESTEP INTERMITTENT CATHETER HAD NO OPEN HOLE AT THE END OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24228793 ↗
• MalfunctionJan 30, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE SURESTEP INTERMITTENT CATHETER HAD KINKED AT THE END AND THE SURESTEP INTERMITTENT CATHETER HAD NO OPEN HOLE AT THE END OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24228792 ↗
• MalfunctionJan 9, 2026Nonstandard Device; Material Twisted/Bent

  IT WAS REPORTED THAT INTERMITTENT CATHETERS HAD BEEN AFFECTED 6 SEPARATE TIMES AT (B)(6) HOSPITAL. ALL AT THE SAME UNIT. LOT#NGKU3578 . LOT#NGKS3046 . LOT#NGKS2199 . PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 26DEC2025, IT WAS REPORTED THAT THE CATHETERS WERE OUTSIDE THE STERILE PACKAGING AND SOME OF THEM WERE KINKED. THE ISSUE WAS DETECTED: MULTIPLE OCCASIONS WHERE THE NURSES WERE OPENING KITS TO STRAIGHT CATHETER. WHETHER THE ISSUE AFFECTED PRODUCT FUNCTIONALITY OR USABILITY VERY INCONVENIENT AS FOR ONE PATIENT THEY HAD TO OPEN 5 KITS TILL THEY GOT ONE THAT WAS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24029086 ↗
• MalfunctionJan 9, 2026Nonstandard Device; Material Twisted/Bent

  IT WAS REPORTED THAT INTERMITTENT CATHETERS HAD BEEN AFFECTED 6 SEPARATE TIMES AT (B)(6). ALL AT THE SAME UNIT. LOT#NGKU3578 LOT#NGKS3046 LOT#NGKS2199 PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 26DEC2025, IT WAS REPORTED THAT THE CATHETERS WERE OUTSIDE THE STERILE PACKAGING AND SOME OF THEM WERE KINKED. THE ISSUE WAS DETECTED: MULTIPLE OCCASIONS WHERE THE NURSES WERE OPENING KITS TO STRAIGHT CATHETER. WHETHER THE ISSUE AFFECTED PRODUCT FUNCTIONALITY OR USABILITY VERY INCONVENIENT AS FOR ONE PATIENT THEY HAD TO OPEN 5 KITS TILL THEY GOT ONE THAT WAS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24029081 ↗
• MalfunctionJan 9, 2026Nonstandard Device; Material Twisted/Bent

  IT WAS REPORTED THAT INTERMITTENT CATHETERS HAD BEEN AFFECTED 6 SEPARATE TIMES AT (B)(6) HOSPITAL. ALL AT THE SAME UNIT. LOT#NGKU3578. LOT#NGKS3046. LOT#NGKS2199. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 26DEC2025, IT WAS REPORTED THAT THE CATHETERS WERE OUTSIDE THE STERILE PACKAGING AND SOME OF THEM WERE KINKED. THE ISSUE WAS DETECTED: MULTIPLE OCCASIONS WHERE THE NURSES WERE OPENING KITS TO STRAIGHT CATHETER. WHETHER THE ISSUE AFFECTED PRODUCT FUNCTIONALITY OR USABILITY VERY INCONVENIENT AS FOR ONE PATIENT THEY HAD TO OPEN 5 KITS TILL THEY GOT ONE THAT WAS OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24029068 ↗
• MalfunctionDec 29, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT OVERNIGHT NURSE FOUND WHAT LOOKED LIKE MOLD ON ONE OF THE CASTEL WIPES IN AN INTERMITTENT CATHETER KIT. THE KIT WAS NOT EXPIRED. WAS CAUGHT BEFORE BEING USED ON PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23915500 ↗
• MalfunctionDec 19, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER WAS ATTEMPTING TO STRAIGHT CATHETER A PATIENT WITH A NURSING STUDENT. THEY HAD GRABBED A 14F STRAIGHT CATH KIT AND USED IT UP TO THE POINT OF INSERTION AND GETTING URINE FLOW, BUT THE URINE FLOW STOPPED IN THE TUBE. IT WAS THEN REALIZED THAT THERE WAS A LITERAL KINK IN THE TUBING NOT ALLOWING THE URINE TO FLOW AND IT WAS UNABLE TO BE STRAIGHTENED OUT. ANOTHER 14F STRAIGHT CATH KIT WAS OBTAINED BY WRITER AND IMMEDIATELY UPON OPENING IT WAS NOTICED THAT THE WHOLE END OF THAT TUBING WAS BENT AT THE END AND WOULD ALSO NOT ALLOW URINE FLOW VERY WELL, SO IT WAS NOT USED. NEXT, WRITER OBTAINED A 16F COUDE STRAIGHT CATH KIT AND NO ISSUES WITH THAT ONE AND WAS ABLE TO THEN STUDENT WAS ABLE TO PERFORM PROCEDURE. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 10DEC2025, IT WAS REPORTED BY THE NURSING INSTRUCTOR ON THE FLOOR THAT DAY AND LEFT THE TWO 14F CATHETERS THAT WERE NOT USEABLE OUT OF THE KIT WITH THE 5 MAIN MANAGER. THEY DO NOT KNOW IF THEY STILL HAVE THEM TWO MONTHS LATER. NURSING INSTRUCTOR ALSO DO NOT HAVE THE PATIENT IDENTIFIER WITH THEM ANYMORE; IT WAS THE SAME FEMALE PATIENT. THE ONLY MEDICAL INTERVENTION REQUIRED WAS THAT IT TOOK THRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850857 ↗
• MalfunctionDec 11, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT CATHETER WAS OUTSIDE OF STERILE FIELD WHEN OPENING TRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778301 ↗
• MalfunctionDec 10, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER HAS SEVERAL STRAIGHT CATHETER KITS PRODUCT # INTP14 THAT THE CATHETER WAS LAYING BETWEEN THE FOLDS OF THE OUTER WRAP THUS COMPROMISING THE POSSIBILITY OF CROSS CONTAMINATION WHEN OPENING THE TRAY UP. CUSTOMER HAVE ATTACHED PICTURES. THEY HAVE 2 DIFFERENT LOT NUMBERS NGKU1438 AND NGKV2964.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771177 ↗
• MalfunctionDec 10, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER HAS SEVERAL STRAIGHT CATHETER KITS PRODUCT # INTP14 THAT THE CATHETER WAS LAYING BETWEEN THE FOLDS OF THE OUTER WRAP THUS COMPROMISING THE POSSIBILITY OF CROSS CONTAMINATION WHEN OPENING THE TRAY UP. CUSTOMER HAVE ATTACHED PICTURES. THEY HAVE 2 DIFFERENT LOT NUMBERS NGKU1438 AND NGKV2964.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771033 ↗
• MalfunctionNov 7, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT INTERMITTENT CATHETER TRAY KIT CONTAINED NO CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23494843 ↗
• MalfunctionNov 5, 2025Incomplete or Missing Packaging; Component Misassembled; Incomplete or Missing Packaging; Component Misassembled

  IT WAS REPORTED THAT THE STRAIGHT CATHETERIZATION KIT WAS FOUND TO BE UNSTERILE UPON REMOVAL FROM PACKAGE. CATHETER TIP WAS PROTRUDING FROM STERILE WRAP, DEEMING IT UNFITS FOR USE. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 16DEC2025, IT WAS REPORTED THAT NO PATIENT IMPACT WAS REPORTED. AFTER IT WAS NOTICED IT WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479828 ↗
• InjuryNov 3, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE STRAIGHT CATHETER KIT WAS FALL APART OF THE CONNECTION POINT BETWEEN THE CATHETER AND THE BAG DURING INSERTION AND POST INSERTION. THIS WAS INTEGRAL TO THEIR URINARY DRAINAGE POLICY AND WAS LIMITED NURSES FROM USING THIS PROTOCOL. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 23452721 ↗
• MalfunctionOct 15, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE CUSTOMER WAS ATTEMPTING TO STRAIGHT CATHETER A PATIENT WITH A NURSING STUDENT. THEY HAD GRABBED A 14F STRAIGHT CATH KIT AND USED IT UP TO THE POINT OF INSERTION AND GETTING URINE FLOW, BUT THE URINE FLOW STOPPED IN THE TUBE. IT WAS THEN REALIZED THAT THERE WAS A LITERAL KINK IN THE TUBING NOT ALLOWING THE URINE TO FLOW AND IT WAS UNABLE TO BE STRAIGHTENED OUT. ANOTHER 14F STRAIGHT CATH KIT WAS OBTAINED BY WRITER AND IMMEDIATELY UPON OPENING IT WAS NOTICED THAT THE WHOLE END OF THAT TUBING WAS BENT AT THE END AND WOULD ALSO NOT ALLOW URINE FLOW VERY WELL, SO IT WAS NOT USED. NEXT, WRITER OBTAINED A 16F COUDE STRAIGHT CATH KIT AND NO ISSUES WITH THAT ONE AND WAS ABLE TO THEN STUDENT WAS ABLE TO PERFORM PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290605 ↗

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