MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549211Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00081317006718), received between Feb 27, 2018 and Apr 16, 2026 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 275CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT IMPLANT DURING A PHYSICAL EXAM AS THE IMPLANT HAD A NOTICEABLY DECREASED VOLUME. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 24896440 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 275CC TISSUE EXPANDERS AND PRESENTED WITH AN INFECTION WITH AN ATYPICAL MYCOBACTERIUM IN ONE OF HER BREASTS POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNKNOWN DATE. INFORMATION ABOUT TWO DEVICES WERE REPORTED: LEFT BREAST: CATALOG #: 3549211, LOT #: 9892897, SERIAL #: (B)(6). RIGHT BREAST: CATALOG #: 3549211, LOT #: 9892897, SERIAL #: (B)(6). THE SIDE OF THE INFECTION (LEFT BREAST, RIGHT BREAST, OR BILATERAL) WAS NOT SPECIFIED. IF CLARIFICATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 20158769 ↗
• InjuryJan 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2022. THE REPORTED DATE OF IMPLANTATION IS PRIOR TO THE DEVICE MANUFACTURE DATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THE CORRECT IMPLANTATION DATE OR DEVICE LOT NUMBER, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16243988 ↗
• InjuryDec 30, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A RECONSTRUCTIVE BREAST SURGERY WITH A 275CC MENTOR TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT EXPERIENCED A DEFLATION OF HER LEFT BREAST PROSTHESIS, WHICH WAS CONFIRMED VIA ULTRASONOGRAPHY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16078339 ↗
• MalfunctionNov 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 275CC DEVICE DEFLATED DURING AN UNSPECIFIED BREAST SURGERY PROCEDURE. THE SURGEON FOUND A PIN HOLE ON THE DEVICE AND DID NOT USE IT. THE SURGERY WAS COMPLETED WITH A DIFFERENT UNSPECIFIED TISSUE EXPANDER. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15848701 ↗
• InjuryApr 15, 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 RECONSTRUCTION PRIMARY WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 275CC AND EXPERIENCED INFECTION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON AN UNSPECIFIED DATE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 14118093 ↗
• InjuryApr 11, 2022Adverse 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 BREAST AUGMENTATION WITH A 275CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPREIENCED UNKNOWN SIDE WOUND INFECTION. AS A RESULT, THE DEVICE WAS EXPLANTED AT AN UNKNOWN DATE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 14077891 ↗
• InjuryOct 8, 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 275CC AND EXPERIENCED DEFLATION ON THE LEFT TISSUE EXPANDER. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 9165726 ↗
• MalfunctionApr 19, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING PRE-OPERATION WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 275CC, THE DOCTOR NOTICED THAT THE IMPLANT EXPANDER HAD A HOLE AND WAS LEAKING. THE EVENT WAS ON (B)(6) 2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7444635 ↗
• InjuryFeb 27, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) CAUCASIAN FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 275CC THAT DEFLATED AFTER IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7301007 ↗

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-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