Natrelle INSPIRA Resterilizable Sizers MSZ-F385Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888628009325), received between Nov 17, 2022 and Sep 15, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Difficult to Open or Remove Packaging Material; Packaging Problem; Difficult to Open or Remove Packaging Material; Packaging Problem

  SALES REPRESENTATIVE REPORTED ¿ISSUES WITH THE PAPER PEELING OFF, CAUSING STERILITY ISSUES WITH THE IMPLANT¿ AND COULD NOT BE OPENED. LATER HEALTHCARE PROFESSIONAL REPORTED "THE OUTER SHRINK WRAP PLASTIC AND BOX WERE UNDAMAGED. THE NURSE PEELED THE PAPER (THERMOFORM SEAL) FROM THE CLAM SHELL, AND IT ONLY PARTIALLY SEPARATED FROM THE PLASTIC SHELL, LEAVING BEHIND PAPER STILL FUSED TO THE OUTER CLAM SHELL. THE OUTER THERMOFORM SEAL DID NOT APPEAR DAMAGED BEFORE OPENING ON EITHER SHELL. I PERSONALLY TRIED TO EXTRACT THE INNER CLAMP SHELL FROM THE CONSTRUCT; HOWEVER, THE PAPER DID SEPARATE, AND I WAS UNABLE TO EXTRACT THE SIZER WITHOUT CONTAMINATION.". DEVICE WAS NOT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23053711 ↗
• MalfunctionSep 11, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  SALES REPRESENTATIVE REPORTED ¿ISSUES WITH THE PAPER PEELING OFF, CAUSING STERILITY ISSUES WITH THE IMPLANT¿ AND COULD NOT BE OPENED. LATER HEALTHCARE PROFESSIONAL REPORTED "THE BOX AND THE SHRINK WRAP PLASTIC AROUND THE BOX WERE UNDAMAGED. THEN THE NURSE ATTEMPTED TO OPEN THE INNER CLAMSHELL BY PEELING OFF THE PAPER (THERMOFORM). THE PAPER SPLIT IN TWO AND DID NOT SEPARATE FROM THE PLASTIC SHELL. IT DID NOT APPEAR DAMAGED. I CAN NOT COMMENT ON THE INNER SEAL BECAUSE WE NEVER GO TO SEE THAT ONE BECAUSE THE OUTER SEAL NEVER SEPARATED CORRECTLY.". DEVICE WAS NOT IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 23034100 ↗
• InjuryApr 15, 2025Material Rupture; Material Rupture

  PATIENT CONTACT OCCURRED AND THE DEVICE WAS NOT IMPLANTED. THIS RECORD IS FOR THE LEFT SIDE. SURGERY WAS COMPLETED WITH A BACKUP DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 21842353 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED LEFT SIDE ¿EARLY ONSET INFECTION¿ AND PROVIDED CAUSE AS "OPEN WOUND CHEST". ADDITIONALLY PROVIDED ¿PURULENT DRAINAGE UNDER BREASTS¿. DEVICE HAS BEEN EXPLANTED AND REPLACED.

  Patient problems: Purulent Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 15814860 ↗

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