MENTOR Smooth Round SPECTRUM 3501410Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00081317001959), received between Apr 29, 2019 and Oct 27, 2020 — classified as 2 injuries.

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

2 other recalls cover devices cleared under the same FDA submission (P990075); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION WITH A MENTOR SMOOTH ROUND SPECTRUM 125CC SALINE BREAST PROSTHESIS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10742001 ↗
• InjuryApr 29, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT WAS UNDERGOING A MENTOR SMOOTH ROUND SPECTRUM 125CC PRIMARY BREAST AUGMENTATION PROCEDURE WITH A SALINE BREAST PROSTHESIS THAT DEFLATED INTRAOPERATIVELY. THE SURGEON PLACED THE DEVICE IN THE RIGHT BREAST CAVITY AND BEGAN TO FILL IT WITH SALINE WHEN IT WAS NOTICED THAT THE VALVE WAS LEAKING. AS A RESULT, THE DEVICE WAS EXPLANTED FROM THE PATIENT.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 8563101 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990075. One submission often covers many models, so check the product and lot details in each record.

• Z-0367-2022 · Sep 30, 2021 · Open, Classified
  MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shel
• Z-2070-2017 · Mar 27, 2017 · Terminated
  Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048