Natrelle INSPIRA Resterilizable Sizers MSZ-F335Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888628009295), received between May 10, 2023 and Sep 25, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 reports).

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2025Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE ¿OPENED A SIZER IN THE OR AND PLACED IT IN THE PATIENT, WITHOUT BEING PUNCTURED BY ANYTHING, THE SIZER BROKE". THERE WAS NO HARM TO THE PATIENT. HEALTHCARE PROFESSIONAL LATER REPORTED "THE IMPLANT WAS RUPTURED" AND "THE SHELL WAS DESTROYED AND SILICONE WAS SPILLING OUT/THE IMPLANT FELL APART". DEVICE WAS NOT IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23143064 ↗
• MalfunctionMay 15, 2025Break; Break

  SALES REPRESENTATIVE REPORTED "RUPTURED GEL SIZER". DEVICE WAS NOT IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 22030224 ↗
• MalfunctionMay 10, 2023Material Rupture; Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED "THE SIZER EXPLODED". THIS RECORD IS FOR AN UNKNOWN SIDE. THE SURGERY WAS COMPLETED WITH A BACKUP DEVICE. THE DEVICE WAS NOT IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16907399 ↗

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 · Terminated
  NATRELLE 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 · Terminated
  Natrelle 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