MENTOR Tissue Expander 3504307MRecalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00081317002437), received between Apr 24, 2018 and May 8, 2025 — classified as 30 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (34 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 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A MENTOR TISSUE EXPANDER 550CC DEVICE THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S RIGHT BREAST TISSUE EXPANDER WAS REPORTED. ADDITIONALLY, THE PATIENT EXPERIENCE AN ALLERGIC REACTION ONE DAY POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR TISSUE EXPANDER 550CC DEVICE ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement; Hypersensitivity/Allergic reaction

  MAUDE report 21990694 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH MENTOR TISSUE EXPANDER 550CC TISSUE EXPANDERS WHEN THE RIGHT BREAST TISSUE EXPANDER DEFLATED POST IMPLANTATION. THE DEFLATION WAS DIAGNOSED VIA ULTRASOUND. ADDITIONALLY, THE ULTRASOUND RESULTS INDICATED CYSTS IN BOTH BREASTS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S LEFT BREAST PROSTHESIS.

  Patient problems: Cyst(s)

  MAUDE report 21716128 ↗
• InjuryMar 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH MENTOR TISSUE EXPANDER 550CC TISSUE EXPANDERS WHEN THE RIGHT BREAST TISSUE EXPANDER DEFLATED POST IMPLANTATION. THE DEFLATION WAS DIAGNOSED VIA ULTRASOUND. ADDITIONALLY, THE ULTRASOUND RESULTS INDICATED CYSTS IN BOTH BREASTS. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. THIS MEDWATCH REPORT IS FOR THE PATIENT¿S RIGHT BREAST PROSTHESIS.

  Patient problems: Cyst(s)

  MAUDE report 21716127 ↗
• InjuryOct 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION WITH A 550CC MENTOR TISSUE EXPANDER ON AN UNSPECIFIED BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED BREAST IMPLANT DEFLATION, DURING THE THIRD EXPANSION SESSION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20518895 ↗
• InjuryApr 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST RECONSTRUCTION WITH A 550CC MENTOR TISSUE EXPANDER EXPERIENCED DEFLATION POST OPERATIVELY. AS A RESULT, EXPLANT WAS PERFORMED ON AN UNKNOWN DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19122417 ↗
• InjuryFeb 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION SURGERY WITH IMPLANTATION OF A 550CC MENTOR TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT EXPERIENCED LEAKING OF THE RIGHT BREAST IMPLANT, AN INFECTION OF THE RIGHT BREAST, AND PAIN AND SWELLING OF THE RIGHT ARM. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A RIGHT-SIDED 555CC MENTOR MEMORYSHAPE BREAST IMPLANT ON (B)(6) 2024.

  Patient problems: Post Operative Wound Infection

  MAUDE report 18785269 ↗
• MalfunctionNov 9, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR TISSUE EXPANDER 550CC DEVICE THAT WOULD NOT RETAIN FLUID POST IMPLANTATION. THE SURGEON ATTEMPTED TO INFLATE THE EXPANDER, BUT AFTER VIEWING THE DEVICE SOME TIME LATER, THE DEVICE DID NOT RETAIN THE FLUID. IT WAS REPORTED THAT THE EXPANDER MIGHT NEED TO BE REPLACED, BUT IT IS CURRENTLY UNKNOWN IF IT WILL BE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18104162 ↗
• InjuryOct 20, 2023Adverse 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 550CC MENTOR TISSUE EXPANDER AND EXPERIENCED AN ADVERSE EVENT POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT. THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023. MENTOR ASSOCIATES HAVE INITIATED FOLLOW UP ATTEMPTS TO COLLECT ADDITIONAL INFORMATION, HOWEVER, THE ATTEMPTS HAVE BEEN UNSUCCESSFUL. IF NEW INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT.

  Patient problems: Insufficient Information

  MAUDE report 17981311 ↗
• MalfunctionAug 16, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 550CC MENTOR BREAST TISSUE EXPANDER DEFLATED DURING A BREAST RECONSTRUCTION SURGERY PRIOR TO BEING IMPLANTED INTO THE PATIENT. HOWEVER, THE SURGERY COMMENCED WITHOUT ANY REPORTED DELAYS AND A NEW IMPLANT WAS USED TO COMPLETE THE IMPLANTATION. NO REPORTED ADVERSE EVENTS OR PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17557905 ↗
• InjuryAug 10, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR TISSUE EXPANDER 550CC DEVICE THAT COULD NOT BE FILLED THROUGH THE PORT. AS A RESULT, THE DEVICE WAS EXPLANTED AND IT WAS REPLACED WITH ANOTHER MENTOR TISSUE EXPANDER 550CC DEVICE ON 10-JUL-2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17504731 ↗
• InjuryJun 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 550CC MENTOR TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNSPECIFIED DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17100852 ↗
• InjuryMay 10, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED SURGERY WITH A 550CC MENTOR TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT EXPERIENCED PAIN AND A DEFLATION OF THE EXPANDER, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Pain

  MAUDE report 16903130 ↗
• InjuryMay 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH A 550CC MENTOR TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON AN UNKNOWN SIDE POST-OPERATIVELY. THE PATIENT HAD SEVERE PAIN DURING THE NIGHT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNSPECIFIED DATE.

  Patient problems: Pain

  MAUDE report 16878287 ↗
• InjuryMay 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH A 550CC MENTOR TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON AN UNKNOWN SIDE POST-OPERATIVELY. THE PATIENT HAD SEVERE PAIN DURING THE NIGHT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNSPECIFIED DATE.

  Patient problems: Pain

  MAUDE report 16878228 ↗
• InjuryMay 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WITH MENTOR TISSUE EXPANDERS 550CC AND EXPERIENCED PAIN AND DEFLATION POST-OPERATIVELY. THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH ANOTHER EXPANDER ON AN UNSPECIFIED DATE.

  Patient problems: Pain

  MAUDE report 16864614 ↗
• InjuryApr 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED SURGERY WITH A MENTOR TISSUE EXPANDER 550CC DEVICE THAT DEFLATED POST IMPLANTATION. ADDITIONALLY, THE PATIENT DEVELOPED PAIN POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH AN UNSPECIFIED MENTOR TISSUE EXPANDER ON AN UNKNOWN DATE.

  Patient problems: Pain

  MAUDE report 16828436 ↗
• MalfunctionApr 7, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT A 550CC MENTOR TISSUE EXPANDER HAD A DEFECTIVE VALVE THAT WAS NOTED INTRAOPERATIVELY. THERE WAS NO ADVERSE EVENT OR INCREASED RISK TO THE PATIENT. THE PROCEDURE WAS CONTINUED USING A BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16702157 ↗
• MalfunctionApr 6, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH A MENTOR TISSUE EXPANDER 550CC SALINE PROSTHESIS EXPERIENCED DEFECTIVE VALVE POST PROCEDURE. THE EXPANDER HAS A FAILURE IN ITS VALVE, NOT ALLOWING THE SUCTION OF THE AIR INFLATED AIR AND CONSEQUENT INSERTION OF THE PROSTHESIS IN THE SUBMUSCULAR PLANE. NO PATIENT CONSEQUENCES REPORTED, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16690930 ↗
• MalfunctionMar 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR TISSUE EXPANDER, 550CC EXP RND REMOTE BREAST IMPLANT EXPERIENCED UNKNOWN-SIDED DEFLATED INTRAOPERATIVELY. DURING THE INTRAOPERATIVE INFLATION TEST, THE EXPANDER HAD A PUNCTURE, THEREFORE, IT WAS NECESSARY TO REPLACE IT WITH AN EXPANSION VALVE OF EQUIVALENT VOLUME, AVAILABLE IN THE HOSPITAL, TO SUCCESSFULLY COMPLETE THE SURGICAL PROCEDURE. NO ADVERSE EVENT OR PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518681 ↗
• MalfunctionFeb 16, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH A MENTOR TISSUE EXPANDER EXP RND REMOTE, 550CC SALINE PROSTHESIS EXPERIENCED, UNKNOWN SIDED DEFLATION INTRAOPERATIVELY. PATIENT WAS UNDERGOING SURGERY TO INCLUDE AN EXPANDER. WHEN TESTED, THE 550 ML EXPANDER SHOWED A HOLE AT THE JUNCTION OF THE PIPE. AS A RESULT, ANOTHER EXPANSION VALVE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENT OR PATIENT CONSEQUENCES WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16390104 ↗
• MalfunctionFeb 8, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 550CC MENTOR TISSUE EXPANDER DEFLATED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO NOTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16325409 ↗
• InjuryJan 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST IMPLANTATION PROCEDURE WITH UNSPECIFIED MENTOR TISSUE EXPANDERS AND EXPERIENCED DEFLATION (SIDE UNKNOWN) 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 16103753 ↗
• MalfunctionDec 12, 2022Connection Problem; Connection Problem

  IT WAS REPORTED THAT 550CC MENTOR TISSUE EXPANDER BEING USED FOR A BREAST SURGERY PROCEDURE RUPTURED INTRAOPERATIVELY. OBSTRUCTION IN THE EXPANSION VALVE SYSTEM WAS FOUND AND IT WAS NOT POSSIBLE TO PRECISELY EMPTY THE AIR CONTAINED IN THE EXPANSION VALVE. DEFECT WAS FOUND IN THE VALVE SYSTEM OF THE TISSUE EXPANDER. IN TIME ANOTHER EXPANDER WAS RECEIVED WHICH WAS USED AS REPLACEMENT AND COMPLY WITH THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES OR ADDITIONAL INFORMATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15959108 ↗
• InjuryJul 15, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 51-YEAR OLD FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION WITH A 550CC MENTOR TISSUE EXPANDER ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT DEFLATION. THE TISSUE EXPANDER WAS FILLED TWO TO THREE TIMES AND THE HOLE WAS DISCOVERED DURING THE SECOND SURGERY. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT WITH ANOTHER UNSPECIFIED TISSUE EXPANDER ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15033803 ↗
• InjuryApr 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO HAD AN UNKNOWN MENTOR TISSUE EXPANDER AND A 550CC MENTOR TISSUE EXPANDER PLACED EXPERIENCED BILATERAL DEFLATION POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2022. SEE 1645337-2022-03645 FOR CONTRALATERAL PROSTHESIS REPORT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13978426 ↗