NATRELLE INSPIRA Single Use Sizers SSZ-F485Recalls & reported problems
Allergan, Inc. · Natrelle Inspira FullProf 485cc SSZ US · Class U
All models of Natrelle Breast Implants (1167) · NATRELLE INSPIRA Single Use Sizers (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888628045118), received between Nov 20, 2025 and Sep 10, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (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
- Material Rupture1
- Unsealed Device Packaging1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Failure of Implant1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Unsealed Device Packaging
Healthcare professional reported "opening a sizer in the operating room" and that the "inner packaging wasn't sealed all the way". There was no patient contact. This record is for the unimplanted device. Surgery was completed using a backup device.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50714069 ↗InjuryNov 20, 2025Material Rupture; Material Rupture
HEALTHCARE PROFESSIONAL REPORTED THROUGH COMPANY REPRESENTATIVE "RUPTURED SIZER DURING INSERTION". THIS RECORD IS FOR AN UNKNOWN SIDE. DEVICE WAS NOT IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 23610621 ↗
Other Sizer, Mammary, Breast Implant Volume devices
- Natrelle INSPIRA Resterilizable Sizers MSZ-F450Allergan, Inc. · Mammary Sizer6 reports
- Natrelle INSPIRA Resterilizable Sizers MSZ-F385Allergan, Inc. · Mammary Sizer4 reports
- NATRELLE INSPIRA Single Use Sizers SSZ-F560Allergan, Inc. · Sizer, Mammary, Breast Implant Volume3 reports
- Natrelle INSPIRA Resterilizable Sizers MSZ-F560Allergan, Inc. · Mammary Sizer3 reports
- MENTOR MemoryGel BOOST Resterilizable Gel Sizer RSZHPB480SMentor Texas L.P. · SIZER, MAMMARY, BREAST IMPLANT VOLUME3 reports
- Natrelle INSPIRA Resterilizable Sizers MSZ-F335Allergan, Inc. · Mammary Sizer3 reports
- NATRELLE INSPIRA Single Use Sizers SSZ-F295Allergan, Inc. · Sizer, Mammary, Breast Implant Volume2 reports
- NATRELLE INSPIRA Single Use Sizers SSZ-X560Allergan, Inc. · Sizer, Mammary, Breast Implant Volume2 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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