MENTOR Tissue Expander 3504305MRecalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00081317002413), received between Feb 16, 2018 and Sep 21, 2026 — classified as 35 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (36 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848308 ↗
• MalfunctionJun 1, 2026Material Rupture

  IT WAS REPORTED THAT A 400CC MENTOR TISSUE EXPANDER PROSTHESIS WAS OBSERVED TO LEAK DURING A BREAST SURGERY. HOWEVER, THE SURGERY COMMENCED WITHOUT ANY REPORTED DELAYS AND A NEW IMPLANT WAS USED TO COMPLETE THE IMPLANTATION. NO ADVERSE EVENTS, PATIENT HARMS, OR PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25347931 ↗
• MalfunctionApr 6, 2026Material Rupture

  IT WAS REPORTED THAT A MENTOR TISSUE EXPANDER WAS FOUND TO BE DEFLATED DURING AN OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED BACKUP DEVICES, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792204 ↗
• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 400CC MENTOR TISSUE EXPANDER AND EXPERIENCED AN INFECTION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNDISCLOSED DATE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23342379 ↗
• InjuryOct 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 400CC MENTOR TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23337688 ↗
• InjuryFeb 13, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RECONSTRUCTION SURGERY WITH A MENTOR TISSUE EXPANDER 400CC DEVICE THAT WAS SUSPECTED TO HAVE DEFLATED POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21376700 ↗
• InjuryAug 11, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR EXP RND REMOTE 400CC SALINE TISSUE EXPANDER EXPERIENCED UNKNOWN SIDED DEFLATION POSTOPERATIVE. AS A RESULT, PATIENT UNDERWENT REPLACEMENT WITH AN UNKNOWN TISSUE EXPANDER ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17513952 ↗
• MalfunctionApr 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 400CC MENTOR TISSUE EXPANDER DEFLATED INTRAOPERATIVELY POST PROCEDURE. THERE WERE NO KNOWN PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16755199 ↗
• InjuryMar 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST RECONSTRUCTION SURGERY WITH A MENTOR TISSUE EXPANDER, EXP RND REMOTE 400CC BREAST IMPLANT EXPERIENCED UNKNOWN SIDED DEFLATION POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16473858 ↗
• MalfunctionJul 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 400CC MENTOR TISSUE EXPANDER WAS DEFLATED OUT OF THE BOX. THE DEVICE WAS NOT USED IN A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15127078 ↗
• InjuryJun 27, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR TISSUE EXPANDER 400CC AND EXPERIENCED INFLAMMATION AND DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2022.

  Patient problems: Local Reaction

  MAUDE report 14831937 ↗
• InjuryApr 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH A 400CC MENTOR TISSUE EXPANDER EXPERIENCED UNILATERAL DEFLATION POST PROCEDURE. AS A RESULT, AN EXPLANT WAS PERFORMED ON AN UNKNOWN DATE POST PROCEDURE. NO ADDITIONAL EVENT DETAILS HAVE BEEN MADE AVAILABLE TO MENTOR AT THIS TIME. IF ADDITIONAL CLARIFICATION IS RECEIVED IN THE FUTURE, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14060697 ↗
• InjuryNov 24, 2021Off-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 PRIMARY BREAST AUGMENTATION SURGERY WITH A FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION SURGERY WITH A 400CC MENTOR TISSUE EXPANDER EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A LIKE DEVICE ON (B)(6) 2021. THIS DEVICE WAS IMPLANTED LONGER THAN SIX MONTHS AND IS A RADOVAN EXPANDER WHICH WAS USED IN A BREAST TISSUE EXPANSION. THEREFORE, THIS IS OFF LABEL USE OF THE DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12872302 ↗
• InjuryNov 10, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST IMPLANTATION PROCEDURE WITH MENTOR TISSUE EXPANDERS 400CC AND EXPERIENCED BILATERAL DEFLATION POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE SECOND OF TWO DEVICES.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12790622 ↗
• InjuryNov 10, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST IMPLANTATION PROCEDURE WITH MENTOR TISSUE EXPANDERS 400CC AND EXPERIENCED BILATERAL DEFLATION POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS REPORT IS FOR THE FIRST OF TWO DEVICES.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12790615 ↗
• InjuryOct 7, 2021Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR TISSUE EXPANDER 400CC DEVICE THAT DEFLATED AFTER IMPLANTATION. AN ULTRASOUND SHOWED DEFLATION OF THE TISSUE EXPANDER IN PATIENT¿S RIGHT BREAST. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR TISSUE EXPANDER 550CC DEVICE ON (B)(6) 2021. THE SUSPECT MEDICAL DEVICE WAS USED IN AN OFF LABEL MANNER. MENTOR RADOVAN TISSUE EXPANDERS ARE NOT TO BE USED FOR BREAST SURGERIES.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12595287 ↗
• InjuryJun 24, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH 400CC MENTOR TISSUE EXPANDER EXPERIENCED EXPANDER DEFLATION POSTOPERATIVELY. THE TISSUE EXPANDER HAD LEAKAGE, AND A SMALL HOLE WAS OBSERVED ON THE SURFACE. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNSPECIFIED DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12063881 ↗
• InjuryJan 28, 2021Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH A 400CC MENTOR TISSUE EXPANDER AND EXPERIENCED UNKNOWN SIDE DEFLATION. AS A RESULT, THE DEVICE WAS EXPLANTED, AND REPLACED WITH CATALOG NUMBER 3545295, AND LOT NUMBER 9417386 ON AN UNKNOWN DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11244226 ↗
• MalfunctionJan 5, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MENTOR TISSUE EXPANDER 400CC DEVICE DEFLATED DURING AN UNSPECIFIED BREAST SURGERY PROCEDURE. IT WAS OBSERVED THAT THE EXPANDER WAS PUNCTURED AND THERE WAS SALINE SOLUTION LEAKAGE. THE DEVICE WAS NOT IMPLANTED IN A PATIENT AND THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11118565 ↗
• InjuryDec 22, 2020Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH 400CC MENTOR TISSUE EXPANDERS AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL DEVICE REMOVAL AND REPLACEMENT WITH A 400CC MENTOR TISSUE EXPANDER, CATALOG NUMBER 3504305M, SERIAL NUMBER (B)(4) ON (B)(6) 2020.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11061303 ↗
• InjuryDec 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST AUGMENTATION WITH A 400CC MENTOR TISSUE EXPANDER AND EXPERIENCED LOCAL REACTION INCLUDING BREAST EDEMA, PAIN, REDNESS, AND DISCHARGE AND DEVICE EXTRUSION ON HER LEFT SIDE POSTOPERATIVELY. AS A RESULT, THE EXPANDER WAS EXPLANTED ON (B)(6) 2020.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Local Reaction

  MAUDE report 11028744 ↗
• InjuryOct 22, 2020Off-Label Use; Material Rupture; Use of Device Problem; Off-Label Use; Material Rupture; Use of Device Problem

  THIS REPORT CONTAINS SUPPLEMENTAL INFORMATION FOR MENTOR ASR REFERENCE NUMBER (B)(4). IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH 400CC MENTOR TISSUE EXPANDERS AND EXPERIENCED DEFLATION ON THE LEFT SIDE AFTER CHEMOTHERAPY AND RADIOTHERAPY POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL ON (B)(6) 2017.

  Patient problems: No Code Available

  MAUDE report 10721872 ↗
• InjuryJul 15, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR TISSUE EXPANDER EXP RND REMOTE 400CC, BREAST IMPLANTS WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION THE DEFLATION HAPPENED AFTER 500CC WATER INJECTION. AS A RESULT PATIENT HAD THE DEVICE REMOVED ON (B)(6) 2020.

  Patient problems: Insufficient Information; No Code Available

  MAUDE report 10280410 ↗
• InjuryMar 27, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH A 400CCC MENTOR TISSUE EXPANDER, SUFFERED BREAST IMPLANT DEFLATION, POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXPLANTATION ON (B)(6) 2020.

  Patient problems: Hematoma; No Code Available

  MAUDE report 9890326 ↗
• InjuryFeb 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A MENTOR TISSUE EXPANDER 400CC AND EXPERIENCED DEFLATION ON THE LEFT TISSUE EXPANDER. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6)2020.

  Patient problems: Insufficient Information; No Code Available

  MAUDE report 9720487 ↗