Thopaz+ (REF 200.5718)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07612367041027), received between Jul 13, 2023 and Sep 10, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Battery Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2025Pumping Stopped; Pumping Stopped

  ON (B)(6) 2025, A FACILITY CONTACTED MEDELA LLC AND ALLEGED THAT WHILE USING A THOPAZ+ PUMP AN INTERNAL ERROR MESSAGE OCCURRED. IT IS UNDETERMINED THE LENGTH OF TIME THE ERROR MESSAGE WAS ON UNTIL DISCOVERED BY THE TREATING SURGEON IN THE MORNING. THE PATIENT DEVELOPED PNEUMOTHORAX.

  Patient problems: Pneumothorax

  MAUDE report 23014949 ↗
• InjuryJul 13, 2023Battery Problem; Battery Problem

  MEDELA AG WAS INFORMED THAT THE AFFECTED DEVICE STOPPED WORKING BECAUSE THE BATTERY WAS DISCHARGED WITHOUT ANY INDICATION. THE PATIENT'S CONDITION THEN DETERIORATED UNTIL THE NURSE REALIZED THAT THE PUMP HAS STOPPED WORKING.

  Patient problems: Insufficient Information

  MAUDE report 17315893 ↗