MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549216Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00081317006763), received between Mar 7, 2018 and Jun 19, 2025 — classified as 19 injuries.

The most frequently reported specific device problem is “Material Rupture” (18 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.

• InjuryJun 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 800CC TISSUE EXPANDER THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE RIGHT BREAST TISSUE EXPANDER WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22293727 ↗
• InjuryMar 27, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN 800CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED A DEFECTIVE DEVICE ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18987981 ↗
• InjuryJan 17, 2024Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH AN 800CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED A DELAMINATION AND DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNDISCLOSED DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18528022 ↗
• InjuryJan 16, 2024Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 800CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS ON AN UNSPECIFIED BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON AN UNSPECIFIED DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18515505 ↗
• InjuryFeb 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION SURGERY WITH A 800CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED EXPANDER DEFLATION AT THE SEAM ON HER RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE EXPANDER WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16408048 ↗
• InjuryNov 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO HAD A 800CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS PLACED EXPERIENCED DEFLATION OF AN UNKNOWN SIDE POST PROCEDURE. AS A RESULT, AN EXPLANT WAS PERFORMED ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15882527 ↗
• InjuryOct 19, 2021Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT REVISION BREAST RECONSTRUCTION WITH A 800CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED EXPANDER DEFLATION ON HER LEFT SIDE POSTOPERATIVELY. THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH CATALOG NUMBER 3341457; SERIAL NUMBER (B)(4) ON THE LEFT SIDE, AND WITH CATALOG NUMBER 3341457; SERIAL NUMBER (B)(4) ON THE RIGHT SIDE ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12660461 ↗
• InjuryNov 12, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 800CC 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: No Code Available

  MAUDE report 10830953 ↗
• InjuryNov 18, 2019Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 800CC TISSUE EXPANDER WHICH THE RIGHT SIDE DEFLATED AFTER IMPLANTATION. THE ISSUE WAS CONFIRMED BY THE PHYSICIAN. AS A RESULT DEVICE WAS EXPLANTED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9337474 ↗
• InjuryJun 11, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT REVISION BREAST AUGMENTATION WITH 800CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS. THE SURGERY WAS PERFORMED AND THE PHYSICIAN CONFIRMED RIGHT SIDE DEFLATION. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8688527 ↗
• InjuryFeb 19, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 800CC AND EXPERIENCED LEFT SIDE DEFLATION OF THE TISSUE EXPANDER. THE PATIENT ALSO EXPERIENCED SEROMA ON THE LEFT BREAST. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 800CC ON (B)(6) 2019. THE PATIENT HAS FULLY RECOVERED AFTER THE SURGERY.

  Patient problems: No Code Available; Seroma

  MAUDE report 8352379 ↗
• InjuryFeb 15, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 800CC AND EXPERIENCED DEFLATION ON THE LEFT BREAST IMPLANT. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR CPX 4 BREAST TISSUE EXPANDER 800CC ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8343776 ↗
• InjuryDec 19, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT BREAST AUGMENTATION REVISION WITH A MENTOR CPX 4 800CC BREAST TISSUE EXPANDER WITH SUTURE TABS. THE BREAST TISSUE EXPANDER WAS FOUND TO BE LEAKING POST PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A SIMILAR MENTOR CPX 4 800CC BREAST TISSUE EXPANDER WITH SUTURE TABS ON (B)(6) 2018; CATALOG # 3549216, S/NS: (B)(4).

  Patient problems: No Code Available

  MAUDE report 8179766 ↗
• InjuryOct 22, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 800CC AND EXPERIENCED DEFLATION ON THE LEFT SIDE. DEFLATION WAS CONFIRMED BY PHYSICIAN DURING EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7993207 ↗
• InjuryAug 29, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 800CC DEVICE THAT DEFLATED AFTER IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 800CC DEVICE ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7831126 ↗
• InjuryMay 17, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WAS GOING TO UNDERGO A BREAST RECONSTRUCTION REVISION WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 800 CC. THE DOCTOR AFTER OPENING THE PACKAGING NOTICED THE PRESENCE OF A MICRO-HOLE IN THE PRODUCT. THERE WAS NO DAMAGE TO THE PATIENT. THE DEVICE WAS REPLACED WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 550 CC ON (B)(6) 2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7522649 ↗
• InjuryMay 8, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) -YEAR-OLD FEMALE UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH AN 800CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS. ON (B)(6) 2017 DEFLATION DUE TO FAILURE OF THE BUFFER ZONE DURING EXPANSION WAS REPORTED, AND THE DEVICE WAS EXPLANTED.

  Patient problems: No Code Available

  MAUDE report 7495285 ↗
• InjuryMar 15, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT REVISION BREAST RECONSTRUCTION ON (B)(6) 2017 WITH A 650CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS ((B)(4)) AND AN 800CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS ((B)(4)). THE PATIENT EXPERIENCED RIGHT SIDE EXPANDER DEFLATION, LEFT BREAST CAPSULAR CONTRACTURE (BAKER GRADE II), LEFT SIDE SEROMA, AND A LEFT SIDE TISSUE EXPANDER MAGNET ISSUE POST BILATERAL MASTECTOMIES AND RECONSTRUCTION. THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH MENTOR IMPLANTS. UPON EXPLANTATION, IT WAS NOTED THAT THE RIGHT DEVICE WAS TOTALLY DEFLATED AND HAD A HOLE AT THE SEAM OF THE EXPANDER, AND WAS LEAKING FROM THE REINFORCED AREA AT THE EDGE OF THE IMPLANT. EXCESS TISSUE(SKIN) BOTH MEDIALLY AND LATERALLY ON THE RIGHT SIDE WAS EXCISED. THE LEFT BREAST WAS EVACUATED OF 600 ML OF FLUID. A TOTAL CAPSULECTOMY WAS PERFORMED ON THE LEFT SIDE. THE LEFT SIDE TISSUE EXPANDER MAGNET HAD REVERSED POLARITY AS IT REPELLED SEVERAL DIFFERENT MAGNA FINDERS THAT WERE USED WHEN DEVICE WAS IMPLANTED, AND ALSO DID THIS WHEN IT WAS REMOVED FROM THE BODY. THE PATIENT ALSO UNDERWENT ADJACENT TISSUE TRANSFER TO REPORT SUNKEN IN DEFOR

  Patient problems: No Code Available

  MAUDE report 7344005 ↗
• InjuryMar 7, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE UNDERWENT PRIMARY BREAST AUGMENTATION WITH AN 800CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED DEFLATION POST PROCEDURE. AS A RESULT, BILATERAL PROSTHESIS REPLACEMENT WAS PERFORMED ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7322672 ↗

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-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-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-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