Thopaz+ (REF 200.5718)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07612367043298), received between Jan 15, 2026 and Jan 15, 2026 — classified as 1 death.

The most frequently reported specific device problem is “Device Fell” (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.

• DeathJan 15, 2026Device Fell

  ON (B)(6) 2026, IT WAS REPORTED TO MEDELA LLC BY MEDELA AG THAT A THOPAZ PLUS WAS PLACED ON A PATIENT WHO LATER DIED.

  Patient problems: Pneumothorax

  MAUDE report 24079523 ↗