CURE CATHETER M10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815947020017), received between Oct 27, 2017 and Oct 27, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Cut In Material” (1 report).

1 other recall cover devices cleared under the same FDA submission (K072539); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjuryOct 27, 2017Material Separation; Cut In Material; Material Separation; Cut In Material

  USER/PATIENT HAD DIFFICULTY PLACING CATHETER AND WHEN NURSE REMOVED IT FROM THE MONTI CHANNEL SHE NOTICED THE TIP WAS BROKEN OFF. USER DID NOT EXAMINE CATHETER OR PACKAGING PRIOR TO USE. EIGHTEEN DAYS AFTER THE EVENT THE PATIENT UNDERWENT A CYTOSCOPY TO REMOVE THE CATHETER TIP FROM HIS BLADDER DURING A SCHEDULED SURGICAL PROCEDURE UNRELATED TO THE EVENT. EVENT DID NOT AFFECT ABILITY TO CATHETERIZE PATIENT. THE CATHETER TIP WAS SUCCESSFULLY REMOVED DURING THE PROCEDURE WITHOUT COMPLICATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6985594 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072539. One submission often covers many models, so check the product and lot details in each record.

• Z-0004-2013 · Sep 19, 2012 · Terminated
  Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (