NATRELLE INSPIRA Single Use Sizers SSZ-X750Recalls & reported problems
Allergan, Inc. · Natrelle Inspira X-Full 750cc 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 10888628045965), received between Sep 4, 2025 and Sep 10, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (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
- Difficult to Open or Remove Packaging Material2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
HEALTHCARE PROFESSIONAL REPORTED "DID NOT PEEL SMOOTHLY, WERE HARD TO GET SIZERS OUT OF CONTAINERS, LEFT PART OF PAPER ON STERILE LIDS, AND LIDS OF OUTER CONTAINER SHREDDED AND LEFT PAPER FILM" DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23022472 ↗MalfunctionSep 4, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
HEALTHCARE PROFESSIONAL REPORTED "DID NOT PEEL SMOOTHLY, WERE HARD TO GET SIZERS OUT OF CONTAINERS, LEFT PART OF PAPER ON STERILE LIDS, AND LIDS OF OUTER CONTAINER SHREDDED AND LEFT PAPER FILM" DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22965390 ↗
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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