Medline DYND160816TRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884389123119), received between Jul 17, 2018 and May 20, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Flush” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2024Material Integrity Problem; Material Integrity Problem

  SAMPLE PORT BECAME DISLODGED.

  Patient problems: Insufficient Information

  MAUDE report 19355521 ↗
• InjuryDec 31, 2020Migration

  IT WAS REPORTED THAT THE TIP OF CATHETER PENETRATED THE BLADDER WALL REQUIRING SURGICAL INTERVENTION.

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

  MAUDE report 11100366 ↗
• InjuryJul 23, 2018Difficult to Flush

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS NOT DRAINING AND COULD NOT BE FLUSHED. THE FOLEY CATHETER WAS REMOVED AND A NEW FOLEY CATHETER WAS INSERTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7711322 ↗
• InjuryJul 17, 2018No Flow

  IT WAS REPORTED THAT A PREVIOUSLY DRAINING FOLEY CATHETER WAS NOTED NON-DRAINING RESULTING IN PATIENT DEVELOPING BLADDER DISTENTION AND POSSIBLE VASOVAGAL RESPONSE.

  Patient problems: Abdominal Distention; Vaso-Vagal Response

  MAUDE report 7694052 ↗