SureStep Intermittent Catheter Tray INTS14Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00801741183218), received between Dec 20, 2021 and Oct 1, 2025 — classified as 5 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (10 reports).

1 FDA recall record name this device's identifier, 1 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 16, 2026.

Recalls naming this device

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-3117-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER HAD VERY POOR DRAINAGE. REGISTERED NURSE HAD TO MANIPULATE THE CATHETER TO ENCOURAGE URINE TO DRAIN. THIS HAD BEEN A REPEATED EVENT ACCORDING TO THE RN MNGR OF THIS L&D UNIT. URINE REMAINS STAGNANT IN CATHETER AND DOES NOT FLOW SMOOTHLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23191351 ↗
• InjuryFeb 27, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT 14 FRENCH STRAIGHT INTERMITTENT CATHETER KIT NOT FULLY DRAINING BLADDER (BATCH #NGJW3745), (BATCH #NGJY1800). 900 WAS OBSERVED IN THE BLADDER SCAN AND ONLY 300 WAS DRAINED. THIS WAS TRAILED MULTIPLE TIMES WITH THE SAME RESULT. STRAIGHT CATHETER WITH DIFFERENT TYPE WAS SUCCESSFUL TO EMPTY BLADDER FULLY. THEY USED DEFECTIVE SUPPLIES SAVED AT THE HUC DESK TO BE PICKED UP SUPPLIES. IT SOUNDED LIKE IT WAS LIKELY A VAPOR LOCK SITUATION WHERE THEY COULD SHARE A COUPLE OF EDUCATION TIPS TO HELP ADDRESS THE ISSUE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21481124 ↗
• InjuryFeb 27, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT 14 FRENCH STRAIGHT INTERMITTENT CATHETER KIT NOT FULLY DRAINING BLADDER (BATCH#: NGJW3745, BATCH#: NGJY1800). 900 WAS OBSERVED IN THE BLADDER SCAN AND ONLY 300 WAS DRAINED. THIS WAS TRAILED MULTIPLE TIMES WITH THE SAME RESULT. STRAIGHT CATHETER WITH DIFFERENT TYPE WAS SUCCESSFUL TO EMPTY BLADDER FULLY. THEY USED DEFECTIVE SUPPLIES SAVED AT THE HUC DESK TO BE PICKED UP SUPPLIES. IT SOUNDED LIKE IT WAS LIKELY A VAPOR LOCK SITUATION WHERE THEY COULD SHARE A COUPLE OF EDUCATION TIPS TO HELP ADDRESS THE ISSUE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21480777 ↗
• MalfunctionFeb 27, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT 14 FRENCH STRAIGHT INTERMITTENT CATHETERS NOT FULLY DRAINING BLADDER. 900 WAS OBSERVED IN THE BLADDER SCAN AND ONLY 300 WAS DRAINED. THIS WAS TRAILED MULTIPLE TIMES WITH THE SAME RESULT. STRAIGHT CATHETER WITH DIFFERENT TYPE OF CATHETER WAS SUCCESSFUL TO EMPTY BLADDER FULLY. USED DEFECTIVE SUPPLIES SAVED AT THE HEALTH UNIT COORDINATOR DESK TO BE PICKED UP SUPPLIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21479647 ↗
• MalfunctionOct 1, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT ONE OF THE UROLOGY TECHNICIANS CAME ACROSS ANOTHER KIT ISSUE. WHEN THEY OPENED THE INTERMITTENT KIT, THE CATHETER WAS ACTUALLY STICKING OUT OF THE STERILE PACKAGING (LOT#NGJU0912 AND LOT#UNK ). PER FOLLOW UP VIA EMAIL ON 26NOV2024, IT WAS REPORTED THAT CATHETER WAS NOT USED ON A PATIENT AS THE CATHETER BROKE STERILE FIELD AS SOON AS THE PACKAGING WAS OPEN. ANOTHER KIT WAS OBTAINED BY THE UROLOGY TECH. WHEN UROLOGY TECH OPENED THE KIT, THE CATHETER WAS ACTUALLY STICKING OUT OF THE STERILE PACKAGING. KIT WAS NOT UTILIZED AND A NEW STERILE KIT WAS OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20345813 ↗
• MalfunctionAug 23, 2024Component Missing; Improper Chemical Reaction; Component Missing; Improper Chemical Reaction

  IT WAS REPORTED THAT THEY WERE HAVING MANUFACTURING OR SUPPLY ISSUES WITH URINARY CATHETER KITS. THE UTS HAVE STATED THEY HAVE FOUND MULTIPLE KITS NOT CONTAINING ANY LUBRICATION. THEY QUESTIONED WHETHER THERE WAS SUPPLY ISSUE WITH LUBRICATION. THESE KITS WERE NOT MARKED WITH A STICKER LIKE OTHER KITS THAT NOTIFY THE USER THERE WERE NO STERILE GLOVES OR PERI WIPES IN THE KIT FOR EXAMPLE. IT JUST MAKES IT HARD TO CATHETERIZE WHEN THERE WERE MULTIPLE PRODUCTS MISSING FROM KIT. THE LOT NUMBER FOR THE 14 FRENCH INTERMITTENT STRAIGHT CATHETER KIT NOT CONTAINING LUBRICATION WAS NGJQ0350.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20056873 ↗
• InjuryApr 24, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT ADULT FEMALE WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) DUE TO SEPTIC SHOCK. PATIENT PLAN OF CARE INCLUDED INTERMITTENT CATHETERIZATION DUE TO THEIR NEUROGENIC BLADDER. AT 05:00, THE NURSE PERFORMED AN INTERMITTENT URINARY CATHETERIZATION AND LEFT THE ROOM WITH THE CATHETER STILL IN PLACE. WHEN THE NURSE RETURNED TO THE ROOM, IT APPEARED THE CATHETER HAD ADVANCED AND UPON REMOVAL, THE CATHETER BECAME SEPARATED FROM THE DRAINAGE BAG AND WAS RETAINED IN THE PATIENT. THE PROVIDERS WERE NOTIFIED, AND A COMPUTED TOMOGRAPHY (CT) OF THE ABDOMEN AND PELVIS REVEALED THE CATHETER COILED IN THE BLADDER. UROLOGIST WAS NOTIFIED AND THE PATIENT UNDERWENT A CYSTOSCOPY TO REMOVE THE RETAINED CATHETER THE NEXT DAY AND WAS DISCHARGED LATER THE SAME DAY. PER THE NURSE, THE PATIENT HAD A LARGER THAN NORMAL URETHRA AND THE REGISTERED NURSE HAD A HARD TIME KNOWING IF THEY WERE IN THE CORRECT PLACE SO THEY ADVANCED THE CATHETER FURTHER THAN NORMAL. THE NURSE LEFT THE PATIENT FOR ABOUT 10 MINUTES WHILE THE CATHETER WAS IN PLACE IN ORDER TO CHECK ON ANOTHER PATIENT. WHEN THE NURSE RETURNED TO THE ROOM, THE CATHETER HAD ADVANCED FURTHER LIKELY DUE TO THE PATIENT MOVING THEIR HIPS. WH

  Patient problems: Foreign Body In Patient

  MAUDE report 19169904 ↗
• MalfunctionApr 10, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THESE STRAIGHT CATHETER KITS WERE TROUBLESOME IN THAT WHEN THE CATHETER WAS HOOKED UP TO THE DRAIN BAG THAT WAS INCLUDED, IT SEVERELY REDUCES THE URINE FLOW AND DID NOT ALLOW THE BLADDER TO PASSIVELY EMPTY. IT SEEMS THE DRAIN BAG SUCTIONED DOWN THAT THAT VACUUM WAS HARD TO OVERCOME. THEY LET THE CATHETER EMPTY INTO A GRADUATED CYLINDER AND THEY USE THESE CATHETERS A LOT FOR THEIR POST OP PATIENTS, AND IT WAS IMPERATIVE THAT THEY BE ABLE TO EMPTY POST OP PATIENT BLADDERS. STAFF IMPLIED THAT THESE WERE A DIFFERENT KIND OR AT LEAST A DIFFERENT BATCH THAN WHAT THEY DID HAVE STOCKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19078550 ↗
• InjuryDec 18, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER BECAME DISCONNECTED FROM THE PRE-ATTACHED DRAINAGE BAG WHICH RESULTED IN MIGRATION OF THE CATHETER AND INTERVENTIONS TO REMOVE THE CATHETER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18345799 ↗
• InjuryNov 17, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER WAS USED ON A PATIENT ON (B)(6) 2023. WHEN THE NURSE PULLED OUT THE CATHETER FROM THE PATIENT, THEY NOTICED THE CATHETER PORT DID NOT RETRACTED WITH REST OF THE CATHETER. ON FURTHER EXAMINATION THE NURSE NOTICED THE CATHETER HAD DISCONNECTED FROM THE END PORT RESULTING WITH THE CATHETER BEING LODGED IN THE PATIENTS BLADDER AND UNABLE TO VISUALIZE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18161954 ↗
• MalfunctionAug 3, 2023Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE BAG COULD NOT DROP DOWN FAR ENOUGH FOR THE URINE TO DRAIN. ALSO STATED THAT IT STARTED, THEN STOPPED AND DID NOT DRAIN FURTHER. SO IN THE MEANTIME, THE NURSES ON THAT FLOOR WERE OPENING A BRAND NEW FULL FOLEY KIT AND TAKING THE CATHETER OUT, THEN DISCARDING THE REST. (PCN INTS14, PCN INTS16). PER FOLLOW UP VIA EMAIL ON 21JUL2023, IT WAS STATED THAT THEY HAD WORKED WITH THE REPRESENTATIVE ON EDUCATION FOR THE UNIT. CURRENTLY THAT HAD A POSITIVE EFFECT ON STAFF¿S USAGE OF THE PRODUCT. PER FOLLOW UP VIA EMAIL ON 21JUL2023, STATED THAT THE CUSTOMER MADE IT CLEAR THAT THE ISSUE HAS BEEN RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17449993 ↗
• MalfunctionJul 10, 2023Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT NURSES WERE COMPLAINED ABOUT SURESTEP SILICONE INTERMITTENT TRAY'S. STAFF WERE STATED THAT THERE WERE TIMES WHEN THEY HAVE TROUBLE DETERMINED IF PATIENT STILL HAD URINE IN BLADDER. AS AN ALTERNATIVE THEY WERE USED FOLEY KITS TO STRAIGHT CATCH BECAUSE OF ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17288631 ↗
• MalfunctionMay 9, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THERE WAS NO URINE OUTPUT FOLLOWING INTERMITTENT CATHETER INSERTION AND THE CATHETER WAS REMOVED AND REVEALED NO PERFORATIONS IN THE END OF THE TUBE AND IT WAS DEFECTIVE PRODUCT NOTED BY THE NURSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16895893 ↗
• MalfunctionApr 19, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT CUSTOMER ATTEMPTED TO STRAIGHT CATHETER A PATIENT ON (B)(6), THE INTERMITTENT CATHETER DID NOT HAVE ANY OPENINGS AT THE END OF THE TUBE FOR FLUID TO FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16768585 ↗
• MalfunctionApr 18, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT NURSE ATTEMPTED TO STRAIGHT CATHETER A PATIENT ON (B)(6) 2023, THE CATHETER DID NOT HAVE ANY OPENINGS AT THE END OF THE TUBE FOR FLUID TO FLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16761547 ↗
• MalfunctionMar 16, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THERE WERE NO HOLES AT THE TIP TO DRAIN THE BLADDER AND THE PACKAGING WITH LOT NUMBER WAS NOT SAVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16551986 ↗
• MalfunctionOct 21, 2022Device Dislodged or Dislocated

  AFTER COMPLETING URINARY CATHETERIZATION ON PATIENT, CLAMP ON CATHETER CLOSED. WHILE REMOVING THE BAG AND CATHETER FROM THE STERILE FIELD, THE CATHETER DISLODGED ITSELF FROM THE COLLECTION BAG(NO TENSION WAS APPLIED). THE REMAINING URINE THAT WAS IN THE CATHETER SPRAYED ON THE BED, AND BEDSIDE TABLE AND FLOOR. FDA SAFETY REPORT ID (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15659213 ↗
• MalfunctionAug 24, 2022Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE SURESTEP INTERMITTENT CATHETER TRAY WAS NOT DRAINING THE BLADDER OR ALLOWING GRAVITY BECAUSE THE BAG WAS ATTACHED WITH IT. IT WAS STATED THAT THE DEVICE WAS ON THE BED AND ONLY 200ML WAS CAPTURED. AFTER 6 PATIENTS COMPLAINED THAT THEIR BLADDERS WERE NOT BEING DRAINED, A NURSE REMOVED THE BAG AND REINSERTED THE CATHETER A PATIENT 30 MINUTES AFTER THE 200ML AND GOT 500ML OUT USING A GRADUATED CYLINDER. PER FOLLOW-UP VIA PHONE ON (B)(6) 2022 , CUSTOMER STATED THAT THE REPRESENTATIVE CAME AND DID AN IN SERVICE TO DEMONSTRATE HOW TO PROPERLY WORK THE CATHETER AND CUSTOMER FELT THAT IT WAS AN EDUCATIONAL ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15282186 ↗
• MalfunctionAug 18, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE FLOW WAS EXTREMELY SLOW IN THE INTERMITTENT CATHETER KIT. CUSTOMER EXPLAINED THE REASON FOR THAT THE DRAIN BAGS MIGHT NEED TO BE SEPARATED OR THE DRAINAGE VALVE COULD BE OPENED AND CLOSED TO FACILITATE FASTER DRAINAGE. STATED THAT IT WAS DIFFICULT TO DETERMINE WHEN THE URINE HAS STOPPED DRAINING FROM THE BLADDER. ALSO THEY HAVE TO MANIPULATE THE DRAIN BAG TO GET IT TO DRAIN AND THE CATHETER SEEMED TOO SHORT AND THE BAG VOLUME WAS INADEQUATE. THE VOLUME OF URINE IN THE DRAIN BAG WAS INACCURATE AND IT DIFFERED FROM THE MEASUREMENT THEY GOT WHEN THEY POUR IT INTO A GRADUATED CONTAINER .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15248405 ↗
• MalfunctionAug 18, 2022Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE FLOW WAS EXTREMELY SLOW IN THE INTERMITTENT CATHETER KIT. CUSTOMER EXPLAINED THE REASON FOR THAT THE DRAIN BAGS MIGHT NEED TO BE SEPARATED OR THE DRAINAGE VALVE COULD BE OPENED AND CLOSED TO FACILITATE FASTER DRAINAGE. STATED THAT IT WAS DIFFICULT TO DETERMINE WHEN THE URINE HAS STOPPED DRAINING FROM THE BLADDER. ALSO THEY HAVE TO MANIPULATE THE DRAIN BAG TO GET IT TO DRAIN AND THE CATHETER SEEMED TOO SHORT AND THE BAG VOLUME WAS INADEQUATE. THE VOLUME OF URINE IN THE DRAIN BAG WAS INACCURATE AND IT DIFFERED FROM THE MEASUREMENT THEY GOT WHEN THEY POUR IT INTO A GRADUATED CONTAINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15248402 ↗
• MalfunctionAug 18, 2022Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE FLOW WAS EXTREMELY SLOW IN THE INTERMITTENT CATHETER KIT. CUSTOMER EXPLAINED THE REASON FOR THAT THE DRAIN BAGS MIGHT NEED TO BE SEPARATED OR THE DRAINAGE VALVE COULD BE OPENED AND CLOSED TO FACILITATE FASTER DRAINAGE. STATED THAT IT WAS DIFFICULT TO DETERMINE WHEN THE URINE HAS STOPPED DRAINING FROM THE BLADDER. ALSO THEY HAVE TO MANIPULATE THE DRAIN BAG TO GET IT TO DRAIN AND THE CATHETER SEEMED TOO SHORT AND THE BAG VOLUME WAS INADEQUATE. THE VOLUME OF URINE IN THE DRAIN BAG WAS INACCURATE AND IT DIFFERED FROM THE MEASUREMENT THEY GOT WHEN THEY POUR IT INTO A GRADUATED CONTAINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15248299 ↗
• MalfunctionJul 21, 2022Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE SURESTEP INTERMITTENT CATHETER DID NOT FULLY EMPTY BLADDER AND FLOW OF URINE WAS RESTRICTED. PER FOLLOW-UP VIA PHONE ON 11JULY2022, IT WAS REPORTED THAT THE SURESTEP INTERMITTENT CATHETER WAS CONSISTENTLY LEAVING 250-300CC OF URINE IN THE BLADDER AFTER CATHETERIZATION. BD PERSON WAS PROVIDING ADDITIONAL EDUCATION TO STAFF ON 12JULY2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15074248 ↗
• MalfunctionJun 28, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE SILICONE INTERMITTENT CATHETER WERE BECOMING DISCONNECTED DURING DRAINING AND NURSE STATED THAT THE CATHETER WAS NOT BEING ATTACHED AT ALL WHEN THEY OPENED THE PACKAGE. IT WAS ALSO STATED THAT THE CUSTOMER HAS OBSERVED THE SAME WITH THE PVC INTERMITTENT CATHETERS. ALSO, NURSE COULD NOT FIGURE OUT HOW TO EMPTY THE LEG BAG AS THEY DID NOT WANT TO THROW FULL BAG OF URINE IN THE GARBAGE, AND IT HAD OCCURRED WITH TWO DIFFERENT NURSES. THE BAG AND THE CATHETER WERE NOT TOGETHER, SO THE NURSE EMPTIED THE BLADDER WITH THE CATHETER AND COLLECTED IT IN THE PROCEDURE TRAY. WHILE THE NURSE HAD THE CATHETER IN THE BLADDER DRAINING URINE, THE LEG BAG CAME OFF THE CATHETER IN THE MIDDLE OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14843380 ↗
• MalfunctionJun 27, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER BECOME DISCONNECTED DURING DRAINING AND STATED THAT THE CATHETER WAS NOT BEING ATTACHED AT ALL WHEN THEY OPENED THE PACKAGE. STATED THAT THE NURSE COULD NOT FIGURE OUT HOW TO EMPTY THE LEG BAG AS THEY DID NOT WANT TO THROW FULL BAG OF URINE IN THE GARBAGE, AND IT WAS OCCURRED WITH TWO DIFFERENT NURSES . THE BAG AND THE CATHETER WERE NOT TOGETHER, SO THE NURSE EMPTIED THE BLADDER WITH THE CATHETER AND COLLECTED IT IN THE PROCEDURE TRAY. WHILE THE NURSE HAD THE CATHETER IN THE BLADDER DRAINING URINE, THE LEG BAG CAME OFF THE CATHETER IN THE MIDDLE OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14831606 ↗
• MalfunctionJun 21, 2022Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED ISSUES WITH THE SS INTERMITTENT STRAIGHT TIP CATHETER. THEY SAID THAT UNLESS THE BLADDER WAS SUPER FULL, THE URINE WOULD NOT FLOW, AND IT WAS HARD TO TELL WHEN THE BLADDER HAD BEEN DRAINED BECAUSE IT APPEARED STUCK AT THE OUTLET. TO THEIR KNOWLEDGE, THEY DID NOT THINK THAT THERE HAD BEEN ANY PATIENT HARM CAUSED, BUT THEY COULD NOT SAY FOR SURE. TO WORK AROUND THIS, THEY HAD BEEN CUTTING THE BAG OFF AND DRAINING IT INTO A BASIN INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14756408 ↗