MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549313Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00081317006794), received between Mar 30, 2018 and Nov 23, 2025 — classified as 16 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (11 reports).

4 other recalls cover devices cleared under the same FDA submission (K130813); they may or may not involve this specific model.

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryNov 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROTHESIS IMPLANTATION SURGERY WITH A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS ON AN UNSPECIFIED BREAST SIDE. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BREAST INFECTION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON AN UNSPECIFIED DATE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23627077 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH MENTOR CPX 4 BREAST TISSUE EXPANDERS WITH SUTURE TABS EXPERIENCED INFECTION (SIDE UNKNOWN) POST-OPERATIVELY, 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.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23607246 ↗
• InjuryNov 19, 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 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED AN INFECTION AFTER SURGERY POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNDISCLOSED DATE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23599715 ↗
• InjuryJan 22, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. DIAGNOSIS WAS MADE THROUGH ULTRASOUND. AS A RESULT, REPLACEMENT WITH A NEW MENTOR TISSUE EXPANDER WAS PERFORMED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 21214174 ↗
• MalfunctionJan 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 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 21080003 ↗
• InjuryOct 29, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST AUGMENTATION WITH A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS ON THE LEFT BREAST. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED, VIA ULTRASOUND, WITH LEFT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20562035 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 450CC DEVICE DEVELOPED AN INFECTION IN HER LEFT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Post Operative Wound Infection

  MAUDE report 20501158 ↗
• MalfunctionJul 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS BEING USED IN A BREAST SURGERY 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 19800961 ↗
• InjuryApr 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST AUGMENTATION PRIMARY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 450CC AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS DISCOVERED DURING EXPLANTATION ON (B)(6) 2024. THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A SIMILAR DEVICE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 19044074 ↗
• InjuryMar 28, 2024Adverse 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 SURGERY WITH IMPLANTATION OF A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS. POST-OPERATIVELY, THE PATIENT EXPERIENCED FEVER, ASTHENIA, FATIGUE, TACHYCARDIA, SYSTEMIC INFLAMMATORY RESPONSE, AND LEUKOCYTOSIS. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL RIGHT-SIDED TISSUE EXPANDER REMOVAL WITHOUT REPLACEMENT ON (B)(6) 2024. DURING THE SURGERY, AN INFECTION IN THE RIGHT BREAST WAS IDENTIFIED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 18993073 ↗
• InjuryOct 6, 2022Adverse 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 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED A SKIN REACTION 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: Skin Inflammation/ Irritation

  MAUDE report 15556308 ↗
• InjuryOct 19, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS, 450CC IMPLANT EXPERIENCED LEFT-SIDED DEFLATION POST PROCEDURE. THE ISSUE WAS DISCOVERED THROUGH ULTRASOUND EXAMINATION. AS A RESULT, PATIENT UNDERWENT REPLACEMENT WITH CAT#: 3549213 ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12658892 ↗
• InjuryAug 23, 2021Adverse 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 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS PROSTHESIS AND EXPERIENCED POSTOPERATIVE LEFT-SIDED GRADE III CAPSULAR CONTRACTURE. AS A RESULT, THE PATIENT UNDERWENT EXPLANATION ON (B)(6) 2021.

  Patient problems: Capsular Contracture

  MAUDE report 12356364 ↗
• MalfunctionOct 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS, 450CC BREAST IMPLANT AND EXPERIENCED LEFT SIDED DEFLATION INTRAOPERATIVELY. THE REPORT STATED WHEN THE EXPANDER WAS PLACED IN THE LEFT BREAST AND THE TEST WITH SERUM WAS PERFORMED, THE RESPECTIVE EXPANDER OVERFLOWED, SHOWING A SMALL LEAK. THE DOCTOR USED ANOTHER EXPANDER WITH CAT#:3549314, SN#: (B)(4), AND COMPLETED THE PROCEDURE. NO ADVERSE EVENT REPORTED.

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

  MAUDE report 10690930 ↗
• InjuryNov 25, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE WHO HAD A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS PLACED EXPERIENCED RIGHT SIDED DEFLATION POST PROCEDURE. THE DEVICE WAS EXPLANTED, AND A HOLE WAS FOUND. NO ADDITIONAL INFORMATION IS AVAILABLE, IF ADDITIONAL INFORMATION BECOMES AVAILABLE IN THE FUTURE, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 9370662 ↗
• InjuryNov 12, 2019Material Rupture; Material Rupture

  IT WAS REPORTED (VIA MW5090033) THAT A FEMALE PATIENT WHO HAD A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED RIGHTED DEFLATION POST PROCEDURE. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2019. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME, IF ADDITIONAL INFORMATION BECOMES AVAILABLE IN THE FUTURE, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 9312699 ↗
• InjuryFeb 28, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED DEFLATION POST PROCEDURE. ABOUT TEN WEEKS AFTER THE EXPANDER WAS PLACED THE PATIENT NOTED THAT THE EXPANDER BEGAN DEFLATING AND TWO SMALL HOLES WERE FOUND ON THE MEDIAL SIDE. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2019.

  Patient problems: Capsular Contracture; No Code Available

  MAUDE report 8380171 ↗
• InjuryDec 3, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 450CC AND EXPERIENCED DEFLATION ON THE TISSUE EXPANDER. THE SIDE IS UNKNOWN. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH TISSUE EXPANDER OF UNKNOWN TYPE ON AN UNKNOWN DATE.

  Patient problems: No Code Available

  MAUDE report 8126433 ↗
• InjuryMar 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. INITIALLY CURRENT EVENT WAS COVERED IN (B)(4). ADDITIONAL INFORMATION WAS RECEIVED FROM AUTHOR ON 03/02/2018. DETAILS OF 7 PATIENTS WERE PROVIDED, THEREFORE CURRENT REPORT IS TO REPORT COMPLICATION OF PATIENT #4, OTHER 6 PATIENTS ARE SUBMITTED TO FDA SEPARATELY. IT WAS REPORTED THAT PATIENT #4 IN THE POST INTERVENTION GROUP UNDERWENT BREAST RECONSTRUCTION SURGERY AND SUFFERED INFECTION RESULTING IN EXPLANTATION. INFECTIONS OCCURRED WITHIN THE FIRST 6 WEEKS FOLLOWING SURGERY. MENTOR DEVICE WITH CATALOG 354-9313, LOT 6798980 WAS USED. DATE OF INFECTION WAS (B)(6) 2014. INFECTION WAS PROCEDURE RELATED, NO BODY IMPAIRMENT WAS INVOLVED. PATIENT REQUIRED HOSPITALIZATION, SURGERY, ANTIBIOTICS AND FULLY RECOVERED. TITLE: ¿ABSORBABLE ANTIBIOTIC BEADS PROPHYLAXIS IN IMMEDIATE BREAST RECONSTRUCTION.¿ THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE EFFECTS OF THIS PROTOCOL MODIFICATION ON PERIPROSTHETIC INFECTION RATES THAT RESULTED IN EXPLANTATION OF THE EXPANDER. THE STUDY WAS CONDUCTED FROM DEC 2012 TO JUNE 2016.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 7385578 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130813. One submission often covers many models, so check the product and lot details in each record.

• Z-1681-2026 · Feb 18, 2026 · Open, Classified
  CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
• Z-2747-2016 · Aug 9, 2016 · Terminated
  MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy
• Z-2781-2016 · Aug 9, 2016 · Terminated
  CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision
• Z-2748-2016 · Aug 9, 2016 · Terminated
  MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy