MENTOR Tissue Expander 3504311MRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00081317002475), received between Jul 23, 2018 and Aug 14, 2025 — classified as 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (12 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT IMPLANTATION OF A 700CC MENTOR TISSUE EXPANDER IN THE RIGHT FLANK 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 22810278 ↗
• InjuryNov 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MALE WHO UNDERWENT AN UNKNOWN SURGERY WITH A MENTOR TISSUE EXPANDER, 700CC SALINE IMPLANT EXPERIENCED UNKNOWN-SIDED DEFLATION POSTOPERATIVE. CRANIAL EXPANSION PATIENT: THE PATIENT WAS STILL IN THE PROCESS OF EXPANSION. PATIENT NOTICED THAT IT BROKE IN THE PAST FEW DAYS. SCALP TISSUE EXPANDER THAT HAS BROKEN IN A PATIENT THE IN-OFFICE EXAMINATIONS DIAGNOSED THE DEFLATION. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Insufficient Information

  MAUDE report 20775364 ↗
• InjuryMar 1, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A MENTOR TISSUE EXPANDER 700CC BEING USED IN A BREAST RECONSTRUCTION WAS FOUND TO BE UNABLE TO BE INFLATED DURING THE OPERATION. THE SURGERY WAS REPORTEDLY PROLONGED 90 MINUTES. THE SURGEON USED BACKUP DEVICES, AND THE SURGERY WAS COMPLETED. NO OTHER ADVERSE EVENTS WERE REPORTEDLY EXPERIENCED BY THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 18818097 ↗
• InjuryJul 7, 2023Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED SURGERY WITH A MENTOR TISSUE EXPANDER 700CC DEVICE THAT DEFLATED POST IMPLANTATION. IT WAS REPORTED THAT THERE WAS A TEAR AND THAT THE BASE WAS COMPLETELY SEPARATED FROM ONE OF THE SIDES.

  Patient problems: Insufficient Information

  MAUDE report 17283665 ↗
• InjuryMar 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A RECONSTRUCTIVE SKIN SURGERY WITH A 700CC MENTOR TISSUE EXPANDER AND EXPERIENCED RIGHT-SIDED DEFLATION POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2022. THE DEVICE WAS DISCARDED INADVERTENTLY UPON EXPLANTATION AND IS NOT AVAILABLE FOR PRODUCT EVALUATION. THE DEVICE WAS IMPLANTED IN THE PATIENT'S RIGHT THIGH. THE EVENT DATE WAS ESTIMATED AS (B)(6) 2022 BASED ON AVAILABLE INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 13695748 ↗
• MalfunctionFeb 26, 2021Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT A 700CC MENTOR TISSUE EXPANDER BEING USED FOR AN UNSPECIFIED LEG SURGERY RUPTURED INTRAOPERATIVELY. THE EXPANDER WAS USED FOR THE PATIENT'S LEFT LEG AND DID NOT INFLATE WITH EXPANSION FLUID DURING THE SURGERY. AS A RESULT, THREE TISSUE EXPANDERS (CATALOG #:3504313M, SERIAL #: (B)(4), ; CATALOG #: 3504310M, SERIAL #: (B)(4); CATALOG #: 3504311M, SERIAL #: (B)(4)) WERE USED, AND THE SURGERY WAS COMPLETED. 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. IT IS CURRENTLY UNKNOWN WHAT TYPE OF LEG PROCEDURE THE PATIENT UNDERWENT WITH THE TISSUE EXPANDER. HOWEVER, FOLLOW-UP IS STILL IN PROGRESS. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11389335 ↗
• InjuryNov 9, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A RECONSTRUCTION SKIN SURGERY WITH TWO 700CC MENTOR TISSUE EXPANDER PROSTHESES AND EXPERIENCED BILATERAL DEFLATION AND WOUND INFECTION POSTOPERATIVELY. ON (B)(6) 2020, THE PATIENT WAS GOING THROUGH AN EXPANSION PROCESS FOR THE EXPANDERS. HOWEVER, THE EXPANSION PROCESS WAS NOT SUCCESSFUL. DUE TO THE FAILURE OF THE EXPANDER EXPANSION, ULTRASOUND WAS PERFORMED BY A RADIOLOGIST, AND THE RESULT INDICATED UNSPECIFIED DEBRIS AND INFECTION FLUID INSIDE OF BOTH EXPANDERS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2020. UPON EXPLANTATION, THE DEVICES WERE FOUND TO BE DAMAGED, AND UNSPECIFIED INFECTED FLUID AND DEBRIS WERE AGAIN OBSERVED INSIDE OF BOTH EXPANDERS. ONE OF THE EXPANDERS (SIDE UNKNOWN) WAS FOUND TO BE DAMAGED AT THE JUNCTION OF THE BASE PLATE, WHILE THE OTHER EXPANDER WAS FOUND TO BE DAMAGED AT NEAR THE PORT. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS FOR THE RIGHT-SIDED PROSTHESIS.

  Patient problems: Deformity/ Disfigurement; Insufficient Information; No Code Available; Unspecified Infection

  MAUDE report 10810134 ↗
• InjuryNov 9, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A RECONSTRUCTION SKIN SURGERY WITH TWO 700CC MENTOR TISSUE EXPANDER PROSTHESES AND EXPERIENCED BILATERAL DEFLATION AND WOUND INFECTION POSTOPERATIVELY. ON (B)(6) 2020, THE PATIENT WAS GOING THROUGH AN EXPANSION PROCESS FOR THE EXPANDERS. HOWEVER, THE EXPANSION PROCESS WAS NOT SUCCESSFUL. DUE TO THE FAILURE OF THE EXPANDER EXPANSION, ULTRASOUND WAS PERFORMED BY A RADIOLOGIST, AND THE RESULT INDICATED UNSPECIFIED DEBRIS AND INFECTION FLUID INSIDE OF BOTH EXPANDERS. AS A RESULT, THE PATIENT UNDERWENT BILATERAL REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2020. UPON EXPLANTATION, THE DEVICES WERE FOUND TO BE DAMAGED, AND UNSPECIFIED INFECTED FLUID AND DEBRIS WERE AGAIN OBSERVED INSIDE OF BOTH EXPANDERS. ONE OF THE EXPANDERS (SIDE UNKNOWN) WAS FOUND TO BE DAMAGED AT THE JUNCTION OF THE BASE PLATE, WHILE THE OTHER EXPANDER WAS FOUND TO BE DAMAGED AT NEAR THE PORT. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS FOR THE LEFT-SIDED PROSTHESIS.

  Patient problems: Deformity/ Disfigurement; Insufficient Information; No Code Available; Unspecified Infection

  MAUDE report 10810124 ↗
• InjuryJul 2, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH MENTOR TISSUE EXPANDER 700CC AND EXPERIENCED UNSPECIFIED DEVICE COMPLICATIONS ON AN UNKNOWN SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10225132 ↗
• InjuryJun 8, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR TISSUE EXPANDER 700CC AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2020.

  Patient problems: Insufficient Information; No Code Available

  MAUDE report 10130639 ↗
• InjuryFeb 21, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A SKIN LACERATION REPAIR WITH A 700CC MENTOR TISSUE EXPANDER PROSTHESIS AND EXPERIENCED POSTOPERATIVE DEFLATION (SIDE UNKNOWN). INFLATION FLUID WAS LEAKING FROM THE EXPANDER, AND THE PATIENT WAS HOSPITALIZED TO REMOVE THE BROKEN EXPANDER. THE DATE OF IMPLANTATION WAS ESTIMATED BASED ON THE INVOICE DATE OF THE DEVICE, AND THE DATE OF EXPLANTATION WAS ESTIMATED BASED ON THE REPORTED EVENT DAY OF (B)(6) 2019.

  Patient problems: Insufficient Information; No Code Available

  MAUDE report 9740861 ↗
• InjuryFeb 20, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A SKIN LACERATION REPAIR SURGERY WITH A MENTOR TISSUE EXPANDER 700CC DEVICE THAT DEFLATED AFTER IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNKNOWN DATE.

  Patient problems: No Code Available

  MAUDE report 9735232 ↗
• InjuryDec 26, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO HAD A 700CC MENTOR TISSUE EXPANDER EXPERIENCED DEFLATION ON AN UNKNOWN SIDE POST PROCEDURE. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME, IF ADDITIONAL INFORMATION IS MADE AVAILABLE IN THE FUTURE, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Insufficient Information; No Code Available

  MAUDE report 9521712 ↗
• InjurySep 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A SURGEON WAS USING A 700CC MENTOR TISSUE EXPANDER TO REMOVE A CONGENITAL NAEVUS FROM A YOUNG FEMALE PATIENT'S BACK (WHOSE AGE WAS UNSPECIFIED), AND DISCOVERED THAT THE DEVICE WAS BROKEN AND DEFLATED. PRIOR TO THE DEFLATION, THE PATIENT'S DEVICE HAD BEEN RECEIVING WEEKLY INFLATIONS. THE PHYSICIAN NOTED THAT THE DEFLATION OCCURRED ON THE POSTERIOR ASPECT OF THE DEVICE, AND THEREFORE COULD NOT HAVE BEEN IATROGENIC IN NATURE. THE IMPACTED DEVICE WAS EXPLANTED FROM THE PATIENT ON AN UNSPECIFIED DATE AND REPLACED WITH A LIKE DEVICE. IF THE DATE OF THE DEVICE'S EXPLANTATION BECOMES KNOWN, MENTOR WILL SUBMIT A FOLLOW-UP REPORT WITH THE NEW INFORMATION.

  Patient problems: No Code Available

  MAUDE report 9089058 ↗
• MalfunctionJul 23, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNKNOWN BREAST AUGMENTATION WITH MENTOR TISSUE EXPENDER SMOOTH RECTANGLE 700CC SALINE BREAST IMPLANTS WHICH THE LEFT SIDE DEFLATED DURING IMPLANTATION. AS A RESULT, ANOTHER IMPLANT CATALOG NUMBER 3504311M, LOT NUMBER 7492171 WAS USED ON (B)(6) 2018. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7709840 ↗