Medline DYND11706Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10080196726479), received between Jul 24, 2019 and Jun 14, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 14, 2022Flushing Problem

  IT WAS REPORTED THAT THE CATHETER WAS PLACED WITHOUT DIFFICULTY HOWEVER WHEN ATTEMPTING TO FLUSH THE CATHETER THE CATHETER WOULD NOT FLUSH OR RETURN URINE. THE BALLOON WOULD NOT DEFLATE AND ULTIMATELY THE CATHETER WAS CUT, THE BALLOON SELF-DEFLATED AND THE CATHETER CAME OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14690600 ↗
• InjuryDec 22, 2021Break

  IT WAS REPORTED THAT A CATHETER WAS PUT IN PLACE PRIOR TO SURGERY AND AFTER THE SURGICAL PROCEDURE, DURING CATHETER REMOVAL, THE FOLEY BROKE INTO PIECES WITHIN THE PATIENT REQUIRING SURGICAL INTERVENTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 13059651 ↗
• MalfunctionJul 24, 2019Deflation Problem

  A MALE PATIENT WAS UNDERGOING A FLUOROSCOPIC VOIDING CYSTOURETHROGRAM (VCUG) EXAM AND THE CLINICIANS EXPERIENCED DIFFICULTY DEFLATING THE BALLOON IN THE CATHETER THAT THE PATIENT HAD IN PLACE. THE RADIOLOGIST WAS ABLE TO USE A MICROPUNCTURE SET TO THEN FINALLY RELEASE THE SALINE FROM THE BALLOON AND REMOVE THE DEFLATED FOLEY FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8821164 ↗