SureStep Intermittent Catheter Tray INTS16Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741183225), received between May 20, 2022 and Jun 19, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THERE ARE CONCERNS THAT DUE TO SIZE OF INTERMITTENT CATHETERS IN THE TRAY, THAT MULTIPLE INSERTIONS ON A PATIENT CAUSE TRAUMA. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 19566414 ↗
• 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 17452470 ↗
• MalfunctionMar 6, 2023Disconnection; Leak/Splash

  AFTER REMOVING STRAIGHT CATHETER FROM PATIENT, THE STAFF BROUGHT CATHETER TO THE TRASH AND CATHETER SPONTANEOUSLY DISCONNECTED FROM TEAL HUB ON CATHETER BAG, EJECTING URINE ON STAFF'S CHEST AND NECK AREA.

  Patient problems: Exposure to Body Fluids

  MAUDE report 16484891 ↗
• InjuryMay 20, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER TRAY WAS STIFFER THAN THE OLDER ONES AND HAD RESULTED IN FOUR PATIENT INJURIES THAT REQUIRED IRRIGATION DUE TO BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 14454865 ↗
• MalfunctionMay 20, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE CUSTOMER RECENTLY CONVERTED FROM URETERAL CATHETER TRAY TO INTERMITTENT CATHETER TRAY AND SAID THAT THE INTERMITTENT CATHETER TRAY WAS STIFFER AND HAD RESULTED IN PATIENT INJURY BY PENETRATING THE URETHRA. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 14454620 ↗