Natrelle 133S Tissue Expanders 133S-FX-14-TRecalls & reported problems
Allergan, Inc. · Natrelle TE Smooth 133S-FX-14-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
- 12
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10888628044043), received between Feb 10, 2020 and Jun 25, 2025 — classified as 10 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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
- Fluid/Blood Leak6
- Difficult to Open or Remove Packaging Material3
- Break2
- Device Contaminated During Manufacture or Shipping1
Patient problems
- Failure of Implant11
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Infection1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjuryJun 25, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
HEALTHCARE PROFESSIONAL REPORTED "THE INNER BOX STUCK AND THEY HAD A VERY HARD TIME GETTING THE IMPLANT OUT". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22333012 ↗MalfunctionJun 20, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
HEALTHCARE PROFESSIONAL REPORTED "THE INNER BOX STUCK AND THEY HAD A VERY HARD TIME GETTING THE IMPLANT OUT". DEVICE REMAINS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 22302623 ↗MalfunctionMay 13, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
HEALTHCARE PROFESSIONAL REPORTED "PACKAGING ERROR WITH A TISSUE EXPANDER, UNABLE TO OPEN". DEVICE WAS NOT IMPLANTED AND PATIENT CONTACT DID NOT OCCUR. SURGERY WAS COMPLETED WITH A BACKUP DEVICE.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 22014872 ↗InjuryOct 24, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
COMPANY REPRESENTATIVE REPORTED "AN EYE-LASH WAS FOUND IN THIS UNOPENED EXPANDER". THE DEVICE WAS NOT IMPLANTED.
Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions
MAUDE report 17997402 ↗InjuryJun 29, 2022Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14851568 ↗InjuryJun 9, 2022Fluid/Blood Leak; Fluid/Blood Leak
COMPANY REPRESENTATIVE REPORTED ON BEHALF OF THE HEALTH PROFESSIONAL "450CC IN A 650 EXPANDER 1 CM RIP RIGHT SIDE." THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 14640751 ↗InjuryMay 20, 2022Break; Break
REPRESENTATIVE REPORTED "A TISSUE EXPANDER THAT BROKE DURING IMPLANTATION." SIDE UNKNOWN. DEVICE WAS NOT IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 14463004 ↗InjuryApr 23, 2021Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED A HOLE IN THE BACK IN THE TISSUE EXPANDER ALONG THE SEAM. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 11719759 ↗InjuryDec 8, 2020Break; Break
HEALTHCARE PROFESSIONAL REPORTED VIA REGULATORY AGENCY "BLUE TAB THAT IT ATTACHED TO EXPANDER WAS NOT ATTACHED AND SITTING IN PATIENT¿S BODY." AFFECTED SIDE IS UNKNOWN. THE DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10970175 ↗InjuryAug 21, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED DEFLATION WITH A TISSUE EXPANDER FOR AN UNKNOWN SIDE. DEVICE HAS BEEN EXPLANTED AND DISCARDED.
Patient problems: Failure of Implant
MAUDE report 10436109 ↗InjuryAug 18, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED UNKNOWN SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.
Patient problems: Failure of Implant
MAUDE report 10420711 ↗InjuryFeb 10, 2020Fluid/Blood Leak; Fluid/Blood Leak
HEALTHCARE PROFESSIONAL REPORTED VIA REGULATORY AGENCY "RUPTURED CAPSULE AND TISSUE EXPANDER IN RIGHT BREAST FLUID TESTED POSITIVE FOR INFECTION". DEVICE HAS BEEN EXPLANTED.
Patient problems: Unspecified Infection
MAUDE report 9687653 ↗
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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