Flora™ Tissue Expander SMOOTHSILK® M-12-375Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07445161020895), received between Nov 26, 2025 and Nov 26, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Break; Leak/Splash; Break; Leak/Splash

  USA. ALLEGEDLY, A LEAK WAS FOUND IN A TISSUE EXPLANDER ON THE 3RD POST OP VISIT TO THE CLINIC. IN THAT FOLLOW-UP VISIT, HER LEFT RECONSTRUCTED BREAST WAS FOUND TO HAVE LESS VOLUME THAN THE RIGHT, AND THE PATIENT REPORTED INCREASED DRAINAGE OUTPUT ON THE IPSILATERAL SIDE. NO PATIENT DEMOGRAPHICS, SUCH AS WEIGHT, OR ETHNICITY, WERE PROVIDED BY THE REPORTER. EFFORTS TO GATHER ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.

  Patient problems: Insufficient Information

  MAUDE report 23660323 ↗