SureStep Intermittent Catheter Tray INTL15Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741183171), received between Aug 22, 2022 and Dec 29, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Restricted Flow rate” (3 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 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-3117-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryOct 25, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT PATIENT WAS GETTING STRAIGHT INTERMITTENT CATHETERIZATION, AND THE TUBING DETACHED, FROM THE DRAINAGE TUBING SYSTEM AND CATHETER WAS LODGED IN THE PATIENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 09 OCT 2024, THERE WAS PATIENT HARM. THEY WERE ASSUMING THAT THERE WAS DETACHMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20533066 ↗
• MalfunctionOct 7, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE BAG OF INTERMITTENT CATHETER TRAY WOULD NOT OPEN AND ALLOW URINE TO DRAIN, IT TOOK 45 MINUTES TO DRAIN 700 ML. IT WAS ALSO STATED THAT THE RESTRICTION OF FLOW RESULTED TO THE BAG BEING FLAT AND ALMOST COMPRESSED TO ITSELF. NURSE DID NOT UTILIZE ANOTHER KIT. IT DID CAUSE PATIENT DISCOMFORT AND PATIENT'S CAREGIVER QUESTIONED WHY IT WAS TAKING SO LONG AND WAS IT NORMAL TO HAVE THIS MUCH ISSUE WITH EQUIPMENT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 20384895 ↗
• MalfunctionOct 4, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE NEW STRAIGHT CATHETER LEG BAG TO DRAIN WAS COLLAPSED ON ITSELF, SO IT DID NOT DRAIN. CUSTOMER HAD A PATIENT THAT IT TOOK 45 MINUTES FOR THE URINE TO FULLY DRAIN. NURSES HAVE SAID THE BAGS WERE SO COMPRESSED THEY DID NOT ALLOW URINE TO FLOW INTO THE BAG. CORRECT BAG WOULD NOT OPEN AND ALLOW URINE TO DRAIN, IT TOOK 45 MINS TO DRAIN 700ML. NURSE DID NOT UTILIZE ANOTHER KIT. DID CAUSE PATIENT DISCOMFORT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20371454 ↗
• MalfunctionDec 28, 2023Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT INACCURATE MEASUREMENTS ON SURESTEP INTERMITTENT TRAY URINE COLLECTION BAG. (LOT#NGHU3339 AND LOT#NGHP1134).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18415734 ↗
• MalfunctionDec 28, 2023Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT INACCURATE MEASUREMENTS ON SURESTEP INTERMITTENT TRAY URINE COLLECTION BAG. (LOT#NGHU3339 AND LOT#NGHP1134).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18409186 ↗
• MalfunctionNov 9, 2023Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT WHEN A CLINICIAN OPENED AN INTERMITTENT TRAY, THE CATHETER WAS HANGING OUT OF THE CSR WRAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18104862 ↗
• MalfunctionJun 27, 2023Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE SURE STEP INTERMITTENT CATHETER TRAY WERE NOT COMPLETELY DRAINING THE PATIENT'S BLADDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210379 ↗
• MalfunctionAug 22, 2022Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT SUPER STEP INTERMITTENT CATHETER TRAY WAS DRAINING URINE SLOWLY INTO THE BAG AND THE CUSTOMER WAS CONCERNED THAT THE URINE WAS BACKFLOWING INTO THE BLADDER. CUSTOMER STATES THAT THERE MIGHT BE AN AIR LOCK OR SIDES OF THE BAG MIGHT STUCK TOGETHER PREVENTING THE URINE FROM FLOWING INTO THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15266710 ↗