ThopazRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07612367014205), received between Jul 27, 2023 and Jul 27, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (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. 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.

• MalfunctionJul 27, 2023Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  MEDELA AG (SWITZERLAND) WAS INFORMED THAT THE THOPAZ TUBING WAS DISCONNECTED AT THE CONNECTING PIECE. TUBING DISCONNECTED SPONTANEOUSLY, WITHOUT PULLING. HEALTH PROFESSIONALS WERE PRESENT WHEN THE TUBE CAME LOOSE. THE TUBING WAS RECONNECTED IMMEDIATELY AND WAS FIXED WITH A TUBE CLAMP. THE PATIENT WAS NOT INJURED, BUT SUCH AN INCIDENT COULD POTENTIALLY LEAD TO A PNEUMOTHORAX ACCORDING TO THE HOSPITAL.

  Patient problems: Insufficient Information

  MAUDE report 17405505 ↗