SureStep Intermittent Catheter Tray INTS16CRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741183249), received between Jan 30, 2026 and Aug 4, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

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. 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 ↗

2. Jan 27, 2022Terminated

   There is a potential to leak from the catheter where it connects to the drain bag

   Z-0667-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2026Disconnection

  It was reported that during a straight in and out catheterization procedure, the coude catheter tubing became disconnected from the collection bag. The device was reported to be intact prior to insertion. Urine initially drained into the collection bag, however, while the user was holding the coude tubing, the tubing separated from the bag and urine drainage stopped. Approximately 300 mL of urine had collected in the bag at the time of disconnection. A subsequent bladder scan indicated greater than 600 mL of urine remained in the patient's bladder. Photographs of the damaged tubing were reportedly taken. No patient injury was reported.

  Patient problems: Urinary Retention

  MAUDE report 50131780 ↗
• MalfunctionJan 30, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE SURESTEP INTERMITTENT CATHETER HAD KINKED AT THE END AND THE SURESTEP INTERMITTENT CATHETER HAD NO OPEN HOLE AT THE END OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24228792 ↗