Natrelle INSPIRA Resterilizable Sizers MSZ-F415Recalls & reported problems
Allergan, Inc. · NATRELLE INSPIRA Rester Szr Sty MSZ-F415 Full · Class U
All models of Natrelle Breast Implants (1167) · Natrelle INSPIRA Resterilizable Sizers (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888628009332), received between Oct 12, 2018 and May 27, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
2 other recalls cover devices cleared under the same FDA submission (K831566); they may or may not involve this specific model.
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.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Material Rupture1
Patient problems
- Failure of Implant1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 27, 2022Material Rupture; Material Rupture
COMPANY REPRESENTATIVE REPORTED UNKNOWN SIDE "THIS SIZER JUST RUPTURED IN A CASE." THE DEVICE WAS NOT IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 14522230 ↗InjuryOct 12, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
PATIENT REPORTED UNKNOWN SIDE SIZER REMAINS IMPLANTED.
Patient problems: No Information
MAUDE report 7960840 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K831566. One submission often covers many models, so check the product and lot details in each record.
- Z-0702-2020 · Nov 6, 2019 · TerminatedNATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel), Inspira F (responsive gel), Inspira LP (responsive gel), Inspira M (respons
- Z-1988-2015 · Jun 8, 2015 · TerminatedNatrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled
Other Mammary Sizer 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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