Natrelle INSPIRA Resterilizable Sizers MSZ-F560Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888628009370), received between Jan 21, 2023 and Jan 16, 2026 — classified as 3 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.

• MalfunctionJan 16, 2026Material Rupture

  HEALTHCARE PROFESSIONAL REPORTED VIA A SALES REPRESENTATIVE "THERE WAS ANOTHER SIZER THAT WAS ALSO RUPTURED AFTER STERILIZATION AFTER JUST 5 CYCLES". THE DEVICE WAS NOT IMPLANTED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24093311 ↗
• MalfunctionNov 10, 2023Material Rupture; Material Rupture

  REVIEWED AN EMAIL FROM (B)(6). FORWARDING AN EMAIL RECEIVED ON 18/OCT/2023, REPORTED "BUSTED". DEVICE NOT IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 18111418 ↗
• MalfunctionJan 21, 2023Device Handling Problem; Device Handling Problem

  HEALTHCARE PROFESSIONAL REPORTED "THAT THE INNER THERMOFORM AND OUTER THERMOFORM TRAYS WERE STUCK TOGETHER ON ALL THE SIZERS THAT WERE USED FOR THE CASE. WE WERE STILL ABLE TO USE THE SIZERS, BUT POSES A GREAT CONCERN TO STERILITY." DEVICE HAS NOT BEEN IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16221495 ↗

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