MENTOR Tissue Expander 3504310MRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00081317002468), received between Aug 23, 2018 and Nov 10, 2025 — classified as 16 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (18 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryNov 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 550CC MENTOR TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON AN UNKNOWN SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23510839 ↗
• InjuryAug 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT IMPLANTATION OF A 550CC MENTOR TISSUE EXPANDER IN THE RIGHT SHOULDER FOR TISSUE EXPANSION OF SCARRED SKIN AREAS. POST-OPERATIVELY, THE PATIENT WAS NOTED TO HAVE A DEFLATED IMPLANT AND YELLOW FLUID WAS NOTED ON ASPIRATION OF THE AREA. AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXCHANGE WITH UNDISCLOSED EXPANDERS ON (B)(6) 2024.

  Patient problems: Local Reaction

  MAUDE report 22810277 ↗
• MalfunctionDec 18, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A 550CC MENTOR TISSUE EXPANDER PACKAGE WAS OPENED PRE-OPERATIVELY AND OBSERVED TO HAVE A HAIR INSIDE THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENTS AS THE EVENT OCCURRED PRE-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20968583 ↗
• InjuryAug 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 550CC MENTOR TISSUE EXPANDER ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A LEAKAGE ON THE RIM OF THE IMPLANT. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17445586 ↗
• InjuryJul 27, 2023Material Rupture; Infusion or Flow Problem; Material Rupture; Infusion or Flow Problem

  IT WAS REPORTED THAT A 40-YEAR-OLD FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR TISSUE EXPANDER, 550CC SALINE PROSTHESIS EXPERIENCED RIGHT SIDED SILENT DEFLATION AND DIFFICULTY WITH EXPANSION FLUID REMOVAL POST PROCEDURE. THE REPORT STATED THAT THE FIRST SURGERY, THE SURGEON FILLED THE TISSUE EXPANDER FOR TWO OR THREE TIMES AT SPECIFIED INTERVALS BUT IT DIDN¿T EXPAND ENOUGH. IN SECOND SURGERY HE FOUND A HOLE ON TISSUE EXPANDER (ON THE BORDER BETWEEN DACRON BASE AND THE MAIN BODY OF TISSUE EXPANDER) AND HE CHANGED IT WITH ANOTHER TISSUE EXPANDER ON AN UNSPECIFIED DATE. NOTE: THE TISSUE EXPANDERS WERE IMPLANTED IN THE PATIENT FOR LONGER THAN 6 MONTHS, WHICH IS CONTRAINDICATED IN THE IFU.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17405210 ↗
• InjuryJun 15, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH AN UNKNOWN MENTOR TISSUE EXPANDER BREAST IMPLANT, EXPERIENCED UNKNOWN SIDED DEFLATION POSTOPERATIVE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement; Insufficient Information

  MAUDE report 14704060 ↗
• InjuryMay 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WITH 550CC 550CC MENTOR RECTANGULAR TISSUE EXPANDER EXPERIENCED RUPTURE POST PROCEDURE. AS A RESULT, PATIENT HAD AN EXPLANTATION ON (B)(6) 2020.

  Patient problems: Insufficient Information

  MAUDE report 14518804 ↗
• InjuryApr 22, 2022Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION SURGERY WITH A 550CC MENTOR TISSUE EXPANDER AND EXPERIENCED UNKNOWN SIDE EXPANDER DEFLATION POSTOPERATIVELY. IT WAS REPORTED THAT THE RADOVAN DEVICE WAS IMPLANTED OFF LABEL FOR FUTURE BREAST RECONSTRUCTION, FOLLOWING DFSP DORSAL DEMOLITION. AFTER EXPLANT ON (B)(6) 2022, IT WAS FOUND THAT THE PRODUCT WAS BROKEN AT ITS BASE (FAR FROM THE VALVE).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14188985 ↗
• InjuryApr 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 550CC MENTOR TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON AN UNKNOWN SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14059470 ↗
• InjuryApr 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR EXP RECT REMOTE 550CC, TISSUE EXPANDER PROSTHESIS EXPERIENCED RIGHT-SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT REPLACEMENT WITH A NEW EXPANDERS ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement; Insufficient Information

  MAUDE report 13978453 ↗
• InjuryDec 17, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD MALE PATIENT UNDERWENT AN UNSPECIFIED RECONSTRUCTIVE SKIN SURGERY WITH A 550 CC MENTOR SMOOTH RECTANGLE TISSUE EXPANDER THAT DEFLATED POSTOPERATIVELY. THE PATIENT HAD SUCCESSFUL INFLATION STAGES PRIOR TO THE EVENT, BUT DURING THIS STAGE, THE DEVICE WOULD NOT INFLATE FURTHER. AS A RESULT, SURGICAL INTERVENTION WAS PERFORMED, WHERE IT WAS FOUND THAT THE DEVICE HAD DEFLATED. IT WAS EXPLANTED THE SAME DAY, ON (B)(6) 2020. THERE ARE NO INDICATIONS OF ANY PATIENT EVENTS OR AESTHETIC FAILURES PRIOR TO THIS DEFLATION.

  Patient problems: Insufficient Information

  MAUDE report 11028367 ↗
• MalfunctionSep 25, 2020Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED BREAST SURGERY, IT WAS NOTICED THAT THE LUMEN OF A 550CC MENTOR TISSUE EXPANDER WAS BLOCKED WHICH DID NOT ALLOW FOR THE INJECTION FLUID TO BE ENTERED INTO THE TISSUE EXPANDER. A SECOND DEVICE WAS AVAILABLE DURING SURGERY WHICH WAS USED INSTEAD. THE DEVICE DID NOT TOUCH THE PATIENT AND WAS NOT IMPLANTED IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 10586188 ↗
• MalfunctionJan 3, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 550CC MENTOR TISSUE EXPANDER BEING USED FOR A SKIN RECONSTRUCTION RUPTURED INTRAOPERATIVELY. DURING A TISSUE EXPANDER REPLACEMENT SURGERY, THE SURGEON FOUND THAT THE DEVICE WAS NOT INFLATING DUE TO SUDDEN SHEAR. AS A RESULT, THE DEVICE WAS REPLACED INTRAOPERATIVELY WITH A 550CC MENTOR TISSUE EXPANDER (CATALOG #: 3504310M, SERIAL #: (B)(4)). NO PATIENT CONSEQUENCES OR PROCEDURAL DELAYS WERE REPORTED. AT THE TIME OF THIS REPORT, THERE IS NO EVIDENCE OF A NEED FOR ADDITIONAL SURGICAL INTERVENTION, BUT A SUPPLEMENTAL REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9548458 ↗
• MalfunctionNov 4, 2019Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE MENTOR TISSUE EXPANDER 550CC HAS DEFLATED INTRA-OPERATIVELY DURING BREAST SURGERY. THE TISSUE EXPANDER WAS NOT ABLE TO GET INFLATED. AS A RESULT, THE TISSUE EXPANDER WAS REPLACED WITH SAME LIKE PRODUCT AND THERE WAS NO CONSEQUENCE OR INVOLVEMENT WITH PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9271519 ↗
• InjuryJun 3, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNKNOWN BREAST RECONSTRUCTION SURGERY WITH MENTOR TISSUE EXPANDER 550CC BREAST IMPLANTS WHICH THE UNKNOWN SIDE DEFLATED AFTER IMPLANTATION. AS A RESULT THE DEVICE WAS REPLACED WITH THE SAME DEVICE. DATE OF REPLACEMENT IS UNKNOWN.

  Patient problems: No Code Available

  MAUDE report 8663047 ↗
• InjuryApr 30, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH THREE MENTOR TISSUE EXPANDER 550CC DEVICES THAT ALL DEFLATED AFTER IMPLANTATION. THESE EXPANDERS BECAME DETACHED FROM THE BACK TWICE. THE FIRST EXPANDER WAS PLACED IN THE UPPER LEFT OF THE PATIENT¿S ABDOMEN, SECOND EXPANDER IN THE LOWER LEFT OF THE PATIENT¿S ABDOMEN, AND THE THIRD EXPANDER IN THE MID RIGHT OF THE PATIENT¿S ABDOMEN. AS A RESULT, THE PATIENT HAD ALL THREE DEVICES EXPLANTED ON (B)(6) 2019. THERE WERE NO REPLACEMENTS FOR THE EXPLANTED DEVICES. THIS MEDWATCH REPORT IS FOR THE DEVICE PLACED IN THE MID RIGHT OF THE PATIENT¿S ABDOMEN.

  Patient problems: No Code Available

  MAUDE report 8565992 ↗
• InjuryApr 30, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH THREE MENTOR TISSUE EXPANDER 550CC DEVICES THAT ALL DEFLATED AFTER IMPLANTATION. THESE EXPANDERS BECAME DETACHED FROM THE BACK TWICE. THE FIRST EXPANDER WAS PLACED IN THE UPPER LEFT OF THE PATIENT¿S ABDOMEN, SECOND EXPANDER IN THE LOWER LEFT OF THE PATIENT¿S ABDOMEN, AND THE THIRD EXPANDER IN THE MID RIGHT OF THE PATIENT¿S ABDOMEN. AS A RESULT, THE PATIENT HAD ALL THREE DEVICES EXPLANTED ON (B)(6) 2019. THERE WERE NO REPLACEMENTS FOR THE EXPLANTED DEVICES. THIS MEDWATCH REPORT IS FOR THE DEVICE PLACED IN THE LOWER LEFT OF THE PATIENT¿S ABDOMEN.

  Patient problems: No Code Available

  MAUDE report 8565975 ↗
• InjuryApr 30, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH THREE MENTOR TISSUE EXPANDER 550CC DEVICES THAT ALL DEFLATED AFTER IMPLANTATION. THESE EXPANDERS BECAME DETACHED FROM THE BACK TWICE. THE FIRST EXPANDER WAS PLACED IN THE UPPER LEFT OF THE PATIENT¿S ABDOMEN, SECOND EXPANDER IN THE LOWER LEFT OF THE PATIENT¿S ABDOMEN, AND THE THIRD EXPANDER IN THE MID RIGHT OF THE PATIENT¿S ABDOMEN. AS A RESULT, THE PATIENT HAD ALL THREE DEVICES EXPLANTED ON (B)(6) 2019. THERE WERE NO REPLACEMENTS FOR THE EXPLANTED DEVICES. THIS MEDWATCH REPORT IS FOR THE DEVICE PLACED IN THE UPPER LEFT OF THE PATIENT¿S ABDOMEN.

  Patient problems: No Code Available

  MAUDE report 8565974 ↗
• InjurySep 13, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH MENTOR TISSUE EXPANDER EXP RECT REMOTE 550CC IMPLANT WHICH THE LEFT SIDE DEFLATED AFTER IMPLANTATION. IN THE MORNING (B)(6), THE IMPLANT WAS EMPTY. PATIENT HAD BEEN SLEEPING ON HER LEFT SIDE WHERE THE IMPLANT WAS PLACED. AS A RESULT PATIENT HAD THE DEVICE REMOVED AND REPLACED WITH CATALOG NUMBER 3504201M ON (B)(6) 2018. THE PATIENT DID NOT EXPERIENCE ANY ACCOMPANYING SYMPTOMS, WAS NOT HOSPITALIZED, AND HAS SINCE FULLY RECOVERED.

  Patient problems: No Code Available

  MAUDE report 7874799 ↗
• InjuryAug 23, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH A MENTOR 550CC BREAST TISSUE EXPANDER ON THE LEFT BREAST EXPERIENCED DEFLATION POST PROCEDURE. IT WAS NOTED THE TISSUE EXPANDER HAD A PERFORATION IN THE OPPOSITE PORTION OF THE VALVE, AT THE BORDER BETWEEN THE SILICONE AND THE RIGID BASE OF THE DEVICE. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A SIMILAR MENTOR 550CC BREAST TISSUE EXPANDER ON (B)(6) 2018; CATALOG # 3504310M, S/NS (B)(4).

  Patient problems: No Code Available

  MAUDE report 7809292 ↗