MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549315Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00081317006817), received between Sep 6, 2018 and Aug 17, 2025 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (9 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION REVISION SURGERY WITH IMPLANTATION OF A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT EXPANDER USING ULTRASOUND IMAGING. AS A RESULT, THE PATIENT UNDERWENT EXCHANGE WITH A MENTOR EXPANDER ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22824524 ↗
• InjuryJul 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 650 CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22532157 ↗
• InjuryMar 27, 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 RECONSTRUCTION PRIMARY WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 650CC AND EXPERIENCED INFECTION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.

  Patient problems: Post Operative Wound Infection

  MAUDE report 18988488 ↗
• InjuryMar 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO HAD A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS PLACED EXPERIENCED LEFT SIDED DEFLATION POSTOPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18906655 ↗
• InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST CAPSULAR CONTRACTURE (BAKER GRADE IV). AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2023.

  Patient problems: Capsular Contracture

  MAUDE report 18154683 ↗
• InjuryJul 17, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED A DEFLATION ON AN UNKNOWN SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17334486 ↗
• MalfunctionMar 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS RUPTURED INTRA-OPERATIVELY DURING A BREAST IMPLANTATION SURGERY. NO REPORT OF PATIENT CONSEQUENCE OR ADVERSE EVENT. AS A RESULT, ANOTHER SET OF IMPLANTS WERE IMPLANTED: (LEFT) 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS CATALOG: 3549214 LOT: 9744943 SN: (B)(4) AND (RIGHT) 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS CATALOG: 3549214 LOT: 9744943 SN: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16584998 ↗
• InjuryNov 4, 2021Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST IMPLANTATION PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 650CC AND EXPERIENCED DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A MENTOR TISSUE EXPANDER (SERIAL NUMBER (B)(4)) ON (B)(6) 2021. IN MENTOR INSTRUCTIONS FOR USE (IFU), IT IS MENTIONED THAT TISSUE EXPANDERS ARE NOT INTENDED FOR IMPLANTATION BEYOND SIX MONTHS. THEREFORE, THIS DEVICE WAS USED IN AN OFF-LABEL MANNER.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12753930 ↗
• InjurySep 29, 2021Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED DEFLATION POST PROCEDURE. THE DEVICE WAS NOTABLY SMALLER THAN THE CONTRALATERAL SIDE. THERE WAS A VISIBLE HOLE UPON EXPLANT. THE DEFLATION WAS DIAGNOSED THROUGH A PHYSICAL EXAMINATION. AS A RESULT, AN EXPLANT WAS PERFORMED ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12551012 ↗
• InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT, WHO'S UNDERGONE BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS ON AN UNSPECIFIED BREAST, SUFFERED PERSISTENT HIGH OUTPUT OF ACUTE INFLAMMATORY LYMPHATIC SECRETION. THE SEROMA HAS REQUIRED PUNCTURE DRAINAGE ONE TO TWO TIMES PER WEEK. THE PATIENT HAD INFLAMMATORY CLINICAL SIGNS THAT MAY CORRESPOND TO AN IMMUNE REACTION TO THE EXPANDER. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Seroma

  MAUDE report 11942923 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST SURGERY PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 650CC AND SUFFERED FROM A LOCAL REACTION ON THE LEFT SIDE. THE PATIENT REPORTED LOCALIZED PAIN WITH A SENSATION OF PRESSURE AROUND THE LEFT TISSUE EXPANDER. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Local Reaction

  MAUDE report 11921455 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WHO HAD A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS PLACED ON AN UNKNOWN DATE EXPERIENCED SEROMA POST PROCEDURE. FUTURE EXPLANT IS INDICATED, HOWEVER, AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. NO ADDITIONAL EVENT DETAILS HAVE BEEN MADE AVAILABLE TO MENTOR AT THIS TIME. IF ADDITIONAL EVENT DETAILS ARE MADE AVAILABLE IN THE FUTURE, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Seroma

  MAUDE report 10900571 ↗
• InjuryOct 22, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED DEFLATION OF A TISSUE EXPANDER POST PROCEDURE. AS A RESULT, THE PATIENT HAD TO HAVE THE DEVICE REMOVED AND REPLACED WITH THE PERMANENT DEVICE PRIOR TO THE DATE ORIGINALLY PLANNED.

  Patient problems: No Code Available

  MAUDE report 9218412 ↗
• InjuryDec 4, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 650CC BREAST PROSTHESIS. SLOW LEAK ON ONE SIDE OF THE EXPANDER WHILE BEING FILLED WAS REPORTED. AS A RESULT, THE PATIENT WAS SCHEDULED FOR REMOVAL AND SECOND STAGE IMPLANTS IMPLANTATION IN (B)(6).

  Patient problems: No Code Available

  MAUDE report 8131603 ↗
• InjurySep 6, 2018Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 650CC IMPLANTS WHICH THE RIGHT SIDE FAILED TO INFLATE AFTER INITIAL INFLATION AND SIX WEEKS AFTER IMPLANTATION. AS A RESULT PATIENT HAD THE EXPANDER REMOVED AND REPLACED WITH ALLERGAN DEVICE AS FOLLOW: CATALOG NUMBER TCM-375, LOT NUMBER 2993976, SERIAL NUMBER (B)(4) ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7852908 ↗

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-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
• 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