SureStep Intermittent Catheter Tray INTAAIRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741183317), received between Nov 22, 2023 and Nov 22, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (1 report).

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. How this data works · Data updated Oct 13, 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-3118-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

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

• InjuryNov 22, 2023Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT URINE STAYED IN THE INTERMITTENT CATHETER TUBE DURING STRAIGHT CATHETERIZATION THEREFORE CUSTOMER COULD NOT TELL WHEN THEIR BLADDER WAS DONE DRAINING AS URINE REMAINED IN THE TUBE. BLADDER SCANNED PATIENT FOR 900CC AND GOT OUT 600CC OF URINE. WAITED FOR PROLONGED AMOUNT OF TIME TO SEE IF ANYMORE URINE WOULD DRAIN BUT COULD NOT TELL WHEN BLADDER WAS FINISHED DRAINING SINCE URINE SAT STAGNANT IN THE FOLEY.

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

  MAUDE report 18192804 ↗