Natrelle 133S Tissue Expanders 133S-FV-16-TRecalls & reported problems
Allergan, Inc. · Natrelle TE Smooth 133S-FV-16-T (US) · Class U · Implant
All models of Natrelle Breast Implants (1167) · Natrelle 133S Tissue Expanders (25)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888628043824), received between May 14, 2025 and Jun 10, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Fluid/Blood Leak1
Patient problems
- Seroma2
- Bacterial Infection1
- Failure of Implant1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED ¿PATIENT REACTION¿. LATER HEALTHCARE PROFESSIONAL REPORTED ¿INFECTED SEROMA AROUND THE IMPLANT¿. LATER HEALTHCARE PROFESSIONAL REPORTED ¿FINEGOLDIA MAGNA¿. THIS RECORD IS FOR THE LEFT SIDE. DEVICE WAS EXPLANTED.
Patient problems: Bacterial Infection; Seroma
MAUDE report 25459260 ↗InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
HEALTHCARE PROFESSIONAL REPORTED "MULTIPLE SEROMAS". THIS RECORD IS FOR THE RIGHT SIDE. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Seroma
MAUDE report 22107620 ↗InjuryMay 14, 2025Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE "DEFLATED DUE TO TEAR". HEALTHCARE PROFESSIONAL LATER REPORTED "BLUE IN THE SUCTION TUBING WHICH WAS THE COLOR ADDED TO THE FLUID TO DETECT LEAKS". DEVICE HAS BEEN EXPLANTED AND DISCARDED.
Patient problems: Failure of Implant
MAUDE report 22019916 ↗
Other Expander, Skin, Inflatable 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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