MENTOR Tissue Expander 3504304MRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00081317002406), received between Sep 28, 2018 and Jan 11, 2024 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (8 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RECONSTRUCTIVE BREAST SURGERY WITH A MENTOR TISSUE EXPANDER 700CC AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18494635 ↗
• InjuryJul 7, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A MENTOR TISSUE EXPANDER 700CC AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A SIMILAR DEVICE ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14950032 ↗
• InjuryFeb 28, 2020Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH MENTOR TISSUE EXPANDER EXP RND REMOTE 700CC IMPLANTS WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION. AS A RESULT PATIENT UNDERWENT BILATERAL MASTECTOMY AND IMMEDIATE RECONSTRUCTION WITH SILICONE IMPLANTS ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 9770007 ↗
• InjuryFeb 25, 2020Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH 700CC MENTOR TISSUE EXPANDERS AND EXPERIENCED POSTOPERATIVE DEFLATION. AS A RESULT, THE PATIENT'S IMPACTED DEVICE WAS EXPLANTED ON (B)(6) 2020. THIS REPORT IS FOR THE PATIENT'S LEFT-SIDED DEVICE.

  Patient problems: No Code Available

  MAUDE report 9751224 ↗
• InjuryFeb 25, 2020Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH 700CC MENTOR TISSUE EXPANDERS AND EXPERIENCED POSTOPERATIVE DEFLATION. AS A RESULT, THE PATIENT'S IMPACTED DEVICE WAS EXPLANTED ON (B)(6) 2020. THIS REPORT IS FOR THE PATIENT'S RIGHT-SIDED DEVICE.

  Patient problems: No Code Available

  MAUDE report 9751223 ↗
• InjuryJan 10, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR TISSUE EXPANDER 700CC DEVICE THAT DEFLATED INTRAOPERATIVELY. THE EXPANDER FOR THE LEFT BREAST FAILED TO CONNECT TO THE VALVE, CAUSING LEAKAGE AND MAKING IT IMPOSSIBLE TO USE. AS A RESULT, THE DEVICE HAD TO BE EXPLANTED FROM THE PATIENT. NO INFORMATION REGARDING A REPLACEMENT DEVICE HAS BEEN RECEIVED.

  Patient problems: No Code Available

  MAUDE report 8237878 ↗
• InjuryNov 7, 2018Off-Label Use; Material Rupture; Use of Device Problem; Off-Label Use; Material Rupture; Use of Device Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT WHO UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR TISSUE EXPANDER 700CC DEVICE ON 09/28/2016 NOTICED SUDDEN LOSS OF VOLUME IN HER RIGHT BREAST. THE PATIENT DENIES THAT THERE WAS ANY TRAUMA OR OTHER INTERCURRENCES. DURING A PHYSICAL EXAMINATION, IT WAS OBSERVED THAT THERE WAS A LOSS OF VOLUME IN THE TISSUE EXPANDER. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR TISSUE EXPANDER 700CC DEVICE ON (B)(6) 2018. DURING EXPLANTATION SURGERY, IT WAS VERIFIED THERE WAS A FISSURE IN THE SUSPECT MEDICAL DEVICE.

  Patient problems: No Code Available

  MAUDE report 8048784 ↗
• MalfunctionNov 2, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MENTOR TISSUE EXPANDER 700CC WAS RUPTURED AND LEAKING. THE LEAKING ISSUE WAS DISCOVERED BEFORE THE SURGERY; THEREFOR, THERE WAS NO PATIENT CONTACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8032844 ↗
• InjurySep 28, 2018Inflation Problem; Connection Problem; Inflation Problem; Connection Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY PROCEDURE WITH A MENTOR TISSUE EXPANDER 700 CC. THE BREAST EXPANDER USED WAS NOT WORKING SATISFACTORILY. THERE WAS A VALVE ISSUE AND A BLOCKAGE IN INFILTRATION. AS A RESULT, THE PATIENT HAD UNDERGONE EXPLANTATION ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7920004 ↗