Medline SAFESECURERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888277678385), received between Sep 23, 2026 and Sep 30, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 reports).

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

• MalfunctionSep 30, 2026Loss of or Failure to Bond

  It was reported that "(low amount of adhesive) Devices stuck on for less than a day" and "( all 6 she said were a bad only stayed on 1 day ) had to use additional tape to keep them on.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946338 ↗
• MalfunctionSep 30, 2026Loss of or Failure to Bond

  It was reported that "customer's wife called in to report the Safesecure detached and caused the catheter to dislodge and balloon came out."

  Patient problems: Insufficient Information

  MAUDE report 50941742 ↗
• MalfunctionSep 23, 2026Loss of or Failure to Bond

  It was reported that the device "Does not stick."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867809 ↗