SureStep Intermittent Catheter Tray INTS14CRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741183232), received between Jul 7, 2021 and Jul 24, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

2 FDA recall records 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-3117-2026 · Root cause: Under Investigation by firm · FDA record ↗

2. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A STRAIGHT CATHETER KIT WAS IDENTIFIED WITH AN UNKNOWN ITEM/MATERIAL IN IT. CUSTOMER HAVE NOT HEARD OF THIS OCCURRENCE WITH ANY OTHER STRAIGHT CATHETER KITS. NO MEDICAL INTERVENTION AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588907 ↗
• MalfunctionSep 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SURESTEP INTERMITTENT CATHETER KITS WERE LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12519372 ↗
• MalfunctionJul 13, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT STRAIGHT CATHETER KITS WERE LEAKING AT THE CONNECTION SITE TO THE DRAIN BAG. PER FOLLOW-UP ON 17JUN21, IT WAS REPORTED THAT TWO STAFF HAD BROUGHT THIS FORWARD. IT WAS STATED THAT ONE STAFF INSERTED THE STRAIGHT CATHETER IN TWO PATIENTS, AND IT LEAKED BOTH TIMES. PER FOLLOW-UP ON 18JUN21, IT WAS REPORTED THAT THE CATHETER THAT LEAKED BELONGED TO LOT# NGEWX143 AND LOT#NGFQ0368. IT WAS ALSO REPORTED THAT IT LOOKED LIKE MORE THAN ONE LOT# WAS LEAKING. IT WAS UNKNOWN WHERE THE LEAK OCCURRED. PER FOLLOW-UP ON 21JUN21, IT WAS STATED THAT AT LEAST 6 LEAKING EVENTS HAVE TAKEN PLACE AS OF LAST WEEK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12164267 ↗
• MalfunctionJul 7, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE STRAIGHT CATHETER KITS WERE LEAKING AT THE CONNECTION SITE TO THE DRAIN BAG. PER FOLLOW UP ON (B)(6) 2021 IT WAS STATED THAT TWO STAFF MEMBERS HAD BROUGHT THIS FORWARD. IT WAS STATED THAT ONE STAFF INSERTED THE STRAIGHT CATHETER IN TWO PATIENTS AND IT LEAKED BOTH THE TIMES. PER FOLLOW UP ON (B)(6) 2021 IT WAS STATED THAT THE CATHETER THAT LEAKED BELONGED TO LOT NGEWX143 AND LOT#NGFQ0368. IT WAS ALSO REPORTED THAT IT LOOKS LIKE MORE THAN ONE LOT WAS LEAKING. IT WAS UNKNOWN WHERE THE LEAKAGE WAS OCCURRING. PER FOLLOW UP ON (B)(2021 IT WAS STATED THAT AT LEAST 6 LEAKING EVENTS HAVE TAKEN PLACE AS OF LAST WEEK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12127721 ↗