CURE CATHETER P14Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815947020284), received between Jul 17, 2020 and Jul 17, 2020 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K110653); they may or may not involve this specific model.

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.

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.

• InjuryJul 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTERMITTENT CATHETER PATIENT (USER) SAID HE GOT A URINARY TRACT INFECTION (UTI) WHILE USING THE P14 CATHETER. DURING FOLLOW-UP, THE PATIENT SAID HE WAS PRESCRIBED A 10 DAY COURSE OF ANTIBIOTIC, TOOK THE FULL COURSE, AND RECOVERED COMPLETELY.

  Patient problems: Urinary Tract Infection

  MAUDE report 10292337 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110653. One submission often covers many models, so check the product and lot details in each record.

• Z-0496-2015 · Nov 11, 2014 · Terminated
  Pediatric, 10Fr, Intermittent Urinary Catheters Model: P10 Pouch Label UPC (P10) *+M405P100C* Intermediate Box Label UPC (P10) *+M405P103F* Carton Label UPC (P10) *+M405P105H* The