MENTOR Tissue Expander 3504303MRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00081317002390), received between May 17, 2018 and Jul 11, 2023 — classified as 11 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (13 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 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A 400CC MENTOR TISSUE EXPANDER WOULD NOT FILL OR INFLATE INTRA-OPERATIVELY DURING A BREAST AUGMENTATION. THERE WAS NO ADVERSE EVENT OR PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302582 ↗
• InjuryMay 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH MENTOR TISSUE EXPANDERS 400CC AND EXPERIENCED DEFLATION (SIDE UNKNOWN) POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL ON AN UNSPECIFIED DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16924443 ↗
• MalfunctionDec 21, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MENTOR TISSUE EXPANDER 400C BEING USED IN A BREAST AUGMENTATION PRIMARY WAS FOUND TO BE RUPTURED DURING THE 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 16025927 ↗
• InjurySep 30, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RECONSTRUCTIVE SKIN SURGERY PROCEDURE WITH A MENTOR TISSUE EXPANDER 400CC DEVICE THAT DEFLATED AFTER IMPLANTATION. DAMAGE TO THE DEVICE WAS VERIFIED WITH ULTRASOUND. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2021. DURING EXPLANTATION SURGERY, THE SURGEON NOTICED THAT THERE WAS A RUPTURE ON ONE OF ITS EDGES.

  Patient problems: Insufficient Information

  MAUDE report 12556195 ↗
• MalfunctionJul 8, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A PRIMARY BREAST AUGMENTATION WITH A MENTOR TISSUE EXPANDER, 400CC SALINE IMPLANT EXPERIENCED LEFT-SIDED DEFLATION INTRAOPERATIVELY. THE DOCTOR USED ANOTHER IMPLANT WITH CAT#:3504303M / SN#: (B)(4) ON (B)(6) 2020, AND COMPLETED THE PROCEDURE. NO PATIENT CONSEQUENCES OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12135932 ↗
• InjuryJan 11, 2021Deflation Problem; Off-Label Use; Material Rupture; Deflation Problem; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A 400CC MENTOR TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON SIDE A POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11150838 ↗
• InjuryDec 30, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A 400CC MENTOR TISSUE EXPANDER AND EXPERIENCED POSTOPERATIVE DEFLATION ON AN UNKNOWN SIDE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Insufficient Information; No Code Available

  MAUDE report 9533640 ↗
• InjuryDec 9, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SKIN LACERATION REPAIR PROCEDURE WITH A MENTOR TISSUE EXPANDER 400CC DEVICE THAT DEFLATED AFTER IMPLANTATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Insufficient Information; No Code Available

  MAUDE report 9441210 ↗
• InjuryNov 13, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MALE PATIENT WHO UNDERWENT BREAST IMPLANT SURGERY WITH A 400CC MENTOR TISSUE EXPANDER EXPERIENCED DEFLATION (SIDE UNKNOWN) POST PROCEDURE. DURING BREAST IMPLANT SURGERY, WHEN THE PHYSICIAN TOOK OFF THE EXPANDER THERE WAS A SLIT ON THE SEAM WHERE IT IS SPLIT. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9316307 ↗
• InjuryOct 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE WHO WAS HAVING A 400CC MENTOR TISSUE EXPANDER PLACED IN HER THIGH EXPERIENCED DEFLATION POST PROCEDURE. THE PATIENT HAD THREE EXPANDERS PLACED IN HER THIGH FOR A PROCEDURE PERFORMED ON (B)(6) 2019. ON (B)(6) 2019 THE PATIENT HAD ONE OF THE EXPANDERS REPLACED DUE TO RUPTURE. THE EXPANDER WAS FOUND TO HAVE DEFLATED AT THE JUNCTURE OF THE HARD BACKING AND THE EXPANDABLE PORTION OF THE DEVICE. RUPTURES WERE FOUND ON THE BOTTOM AND AT THE CORNER OF THIS AREA. THE PATIENT WAS DISCHARGED AND SENT HOME ON THAT SAME DATE. A MEDWATCH WAS SUBMITTED BY THE HOSPITAL IN WHICH THE PROCEDURE WAS PERFORMED.

  Patient problems: No Code Available

  MAUDE report 9181288 ↗
• InjurySep 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT AN (B)(6) MONTH-OLD MALE PATIENT WHO UNDERWENT IMPLANTATION WITH 2 MENTOR TISSUE EXPANDER 400CC ON (B)(6) 2019 FOR EXCISION PROCEDURE FOR A GIANT CONGENITAL NEVUS ON HIS UPPER BACK EXPERIENCED DEFLATION OF ONE OF THE IMPLANTS TWO WEEKS POST PROCEDURE. PER PARENT, THE WOUND STARTED LEAKING A BLUE LIQUID WHICH TURNED OUT TO BE A METHANOL BLUE THAT THE DOCTOR USED TO FILL UP THE EXPANDER. THE PATIENT WAS IMMEDIATELY READMITTED ON (B)(6) 2019 AND UNDERWENT SURGERY TO REMOVE AND REPLACE THE LEAKING EXPANDER WITH A MENTOR TISSUE EXPANDER 400CC.

  Patient problems: No Code Available

  MAUDE report 9084066 ↗
• MalfunctionFeb 5, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A MENTOR 400CC TISSUE EXPANDER THAT DEFLATED INTRAOPERATIVELY.  AS A RESULT, THE DEVICE WAS REMOVED AND REPLACED WITH A MENTOR 300CC TISSUE EXPANDER, AND THE SURGERY CONTINUED. THERE WAS NO REPORT OF A SIGNIFICANT PROCEDURAL DELAY OR ANY PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8305669 ↗
• InjuryNov 20, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH A MENTOR 400CC TISSUE EXPANDER. THE DEVICE WAS INFLATED WITH 50CC WHEN FIRST IMPLANTED AND WAS ATTEMPTED TO INFLATE MORE ON THE SECOND DAY BUT THE TISSUE EXPANDER EXPERIENCED A DEFORMATION. AS A RESULT, THE DEVICE WAS REPLACED WITH A SIMILAR MENTOR 400CC TISSUE EXPANDER ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8093050 ↗
• InjurySep 21, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A MENTOR TISSUE EXPANDER 400CC. A HOLE WAS FOUND IN THE TISSUE EXPANDER WHICH PREVENTED IT FROM EXPANDING ENOUGH. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A SIMILAR MENTOR TISSUE EXPANDER 400CC ON (B)(6) 2018; CATALOG # 3504303M, LOT 7319924.

  Patient problems: Deformity/ Disfigurement; No Code Available

  MAUDE report 7898905 ↗
• MalfunctionJul 26, 2018Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT A MENTOR TISSUE EXPANDER 400CC BREAST PROSTHESIS WOULD NOT DEFLATED CORRECTLY AS THE PHYSICIAN TRIED TO USE IT. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7724640 ↗
• InjuryMay 17, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT HAD UNDERGONE A BREAST RECONSTRUCTION REVISION PROCEDURE WITH A MENTOR TISSUE EXPANDER 400CC AND EXPANDER EXPLODED ON THE LEFT BREAST IMPLANT WHILE PLACING INTO POUCH WHICH WAS PREPARED PREVIOUSLY. IT IS UNKNOWN IF THERE WAS PATIENT CONTACT WITH THE DEVICE. AS A RESULT, THE PATIENT HAD A REPLACEMENT WITH A MENTOR TISSUE EXPANDER 400CC ON (B)(6) 2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7524517 ↗