Flora™ Tissue Expander SMOOTHSILK® H-13-545Recalls & reported problems
Establishment Labs S.A. · Flora™ Tissue Expander SMOOTHSILK® Motiva® Flora® SmoothSilk Tissue Expander - Corsé High Height 545cc · Class U · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07445161020956), received between Nov 27, 2025 and Mar 4, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash2
- Break1
Patient problems
- Insufficient Information3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 4, 2026Leak/Splash
USA. ALLEGEDLY, A PATIENT WHO UNDERWENT BREAST RECONSTRUCTION SURGERY PRESENTS A LEAK NOT RELATED TO RUPTURE IN ONE OF HER TISSUE EXPANDERS ((B)(6)). 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 24512507 ↗InjuryFeb 20, 2026Break
USA. ALLEGEDLY, IN A PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION WITH A TISSUE EXPANDER, ONE OF HER TISSUES PRESENTED LEAKS, AND A RUPTURE WAS FOUND (SN (B)(6). 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 24404924 ↗MalfunctionNov 27, 2025Leak/Splash; Leak/Splash
USA. IT HAS BEEN ALLEGED THAT SOME PATIENTS IMPLANTED WITH MOTIVA FLORA TISSUE EXPANDER LOT NUMBER 25031568 ARE EXPERIENCING LEAKS. AT THIS TIME, IT IS UNKNOWN WHICH SERIAL NUMBER CORRESPONDS TO EACH PATIENT OR THE SPECIFIC OUTCOME OF THE ISSUE. EFFORTS TO OBTAIN ADDITIONAL INFORMATION ARE ONGOING, AND THE INVESTIGATION REMAINS IN PROGRESS.
Patient problems: Insufficient Information
MAUDE report 23666270 ↗
Other Tissue Expander And Accessories devices
- B.BRAUN 7B3050B. Braun Medical Inc. · EXPANDER, SKIN, INFLATABLE1 recall40 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549314Mentor Texas L.P. · EXPANDER, SKIN, INFLATABLE1 recall22 reports
- MENTOR CPX4 PLUS, Smooth, Medium Height SCPX146MHMentor Texas L.P. · Expander, skin, inflatable1 recall18 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MX-13-TAllergan, Inc. · Expander, Skin, Inflatable1 recall16 reports
- MENTOR ARTOURA PLUS, Smooth, Ultra High Profile SDC135UHMentor Texas L.P. · Expander, skin, inflatable1 recall14 reports
- MENTOR ARTOURA PLUS, Smooth, High Profile SDC150HMentor Texas L.P. · Expander, skin, inflatable1 recall14 reports
- MENTOR ARTOURA PLUS, Smooth, Ultra High Profile SDC120UHMentor Texas L.P. · Expander, skin, inflatable1 recall14 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MV-14-TAllergan, Inc. · Expander, Skin, Inflatable1 recall13 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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