NATRELLE INSPIRA Single Use Sizers SSZ-F560Recalls & reported problems
Allergan, Inc. · Natrelle Inspira FullProf 560cc 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
- 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 10888628045132), received between Oct 23, 2023 and Apr 24, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Unsealed Device Packaging” (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
- Unsealed Device Packaging2
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 24, 2026Material Rupture
SALES REPRESENTATIVE REPORTED "GEL SIZER RUPTURING DURING SURGERY". DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24987431 ↗MalfunctionOct 15, 2025Unsealed Device Packaging; Unsealed Device Packaging
HEALTHCARE PROFESSIONAL REPORTED "BREAST SIZER WAS OPENED AND ST NOTICED THAT THE PACKAGE WAS NOT COMPLETELY SEALED AND THEREFORE NOT STERILE". THE DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23279884 ↗InjuryOct 23, 2023Unsealed Device Packaging; Unsealed Device Packaging
HEALTHCARE PROFESSIONAL REPORTED "BREAST SIZER WAS OPENED AND ST NOTICED THAT THE PACKAGE WAS NOT COMPLETELY SEALED AND THEREFORE NOT STERILE." THE DEVICE WAS NOT IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17989459 ↗
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 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
- NATRELLE INSPIRA Single Use Sizers SSZ-X495Allergan, 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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