MENTOR CPX 4 Breast Tissue Expander 3548214Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00081317006558), received between Mar 7, 2018 and Mar 13, 2024 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (17 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER ON THE RIGHT BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED RIGHT BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18894860 ↗
• InjuryMar 8, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER, 550CC SALINE BREAST IMPLANT EXPERIENCED LEFT-SIDED DEFLATION POSTOPERATIVE. . AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18870686 ↗
• InjuryFeb 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROSTHESIS IMPLANTATION SURGERY WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER ON AN UNSPECIFIED BREAST. POST-OPERATIVELY, THE PATIENT SUFFERED BREAST IMPLANT DEFLATION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18792976 ↗
• InjuryDec 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER, 550CC TISSUE EXPANDER SALINE IMPLANT, EXPERIENCED UNKNOWN- SIDED DEFLATION POST PROCEDURE. IMAGING CONFIRMED THE ISSUE. AS A RESULT, PATIENT UNDERWENT REMOVAL ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18400920 ↗
• InjuryJul 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON AN UNKNOWN SIDE POST-OPERATIVELY. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17261824 ↗
• InjuryJul 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON AN UNKNOWN SIDE POST-OPERATIVELY. THE BREAST TISSUE EXPANDER BEGAN TO DEFLATE AFTER BEING HIT ON THE BREAST BY A CHILD. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6), 2022.

  Patient problems: Crushing Injury

  MAUDE report 15104698 ↗
• InjuryMay 24, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A CE MED HEIGHT TE 550CC TISSUE EXPANDER THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE LEFT BREAST TISSUE EXPANDER WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNKNOWN DATE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14492717 ↗
• InjuryJan 27, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT UNSPECIFIED BREAST RECONSTRUCTION WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER, 550CC, SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT PATIENT HAD THE EXPANDER REMOVED WITH NO REPLACEMENT ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11240658 ↗
• InjuryNov 20, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 550CC MENTOR CPX 4 BREAST TISSUE EXPANDERS AND EXPERIENCED DEFLATION ON AN UNSPECIFIED SIDE POSTOPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10880425 ↗
• InjuryJun 15, 2020Off-Label Use; Material Rupture; Off-Label Use; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER 550 CC AND SUFFERED FROM DEFLATION OF THE RIGHT TISSUE EXPANDER. THE TISSUE EXPANDER WAS USED FOR MORE THAN 6 MONTHS AND THEREFORE, WAS USED OFF-LABEL PER MENTOR IFU. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH GEL MENTOR BREAST IMPLANT ON (B)(6) 2020.

  Patient problems: No Code Available

  MAUDE report 10155194 ↗
• MalfunctionJun 15, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MENTOR CPX 4 BREAST TISSUE EXPANDER 550CC BEING USED IN A BREAST SURGERY WAS ACCIDENTALLY DEFLATED BY THE ATTENDING SURGEON 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 Consequences Or Impact To Patient

  MAUDE report 10154152 ↗
• InjuryMar 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A REVISION BREAST RECONSTRUCTION WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER AND EXPERIENCED POSTOPERATIVE RIGHT-SIDED BREAST CANCER. AS A RESULT, THE PATIENT¿S EXPANDER WAS REPLACED WITH A 500CC MENTOR SMOOTH ROUND MODERATE PLUS PROFILE PROSTHESIS (CATALOG #: 3502500, LOT #: 9371038) ON (B)(6) 2019. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL DETAILS REGARDING THIS EVENT. HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE IN THE FUTURE.

  Patient problems: Cancer; No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 9833022 ↗
• InjuryDec 2, 2019Material Discolored; Device Contamination with Body Fluid; Material Discolored; Device Contamination with Body Fluid

  IT WAS REPORTED THAT FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION WITH 550CC MENTOR CPX 4 BREAST TISSUE EXPANDERS. DURING THE UPGRADE PROCEDURE TO BREAST IMPLANTS, IT WAS DISCOVERED THAT ONE OF THE EXPANDERS WAS DISCOLORED AND FILLED WITH WHAT APPEARED TO BE BLOOD.

  Patient problems: No Code Available

  MAUDE report 9398510 ↗
• InjurySep 23, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 9105924 ↗
• InjuryJul 30, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION SURGERY WITH MENTOR TISSUE EXPANDER, MEDIUM HEIGHT TE 550CC IMPLANTS WHICH THE RIGHT SIDE DEFLATED AFTER IMPLANTATION. THE ISSUE WAS DISCOVERED ON THE DAY OF THE SURGERY. AS A RESULT PATIENT HAD THE DEVICE REMOVED AND REPLACED WITH IMPLANT ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8841535 ↗
• InjuryOct 28, 2018Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST AUGMENTATION REVISION PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER 550CC DEVICE AND AN UNSPECIFIED MENTOR TISSUE EXPANDER DEVICE THAT BOTH DEFLATED AFTER IMPLANTATION. THE PATIENT AND THE SURGEON BOTH CLAIM THAT THE DEVICES LEAKED NOT LONG AFTER THEY WERE IMPLANTED (APPROXIMATELY ONE WEEK AFTER SURGERY). AS A RESULT, THE PATIENT UNDERWENT BILATERAL EXPLANTATION AND REPLACEMENT WITH UNSPECIFIED BREAST PROSTHESES ON AN UNKNOWN DATE. THIS MEDWATCH REPORT IS FOR THE MENTOR CPX 4 BREAST TISSUE EXPANDER 550CC DEVICE.

  Patient problems: No Code Available; Seroma; Unspecified Infection

  MAUDE report 8011969 ↗
• InjuryJul 16, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER 550CC NOTICED THE TISSUE EXPANDER TO BE DEFLATED ONE MORNING AFTER IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH AN UNSPECIFIED AIR EXPANDER ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7691238 ↗
• InjuryMar 27, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH MENTOR CPX 4 BREAST TISSUE EXPANDER 550CC SILTEX DEVICE. IT WAS REPORTED THAT THE PATIENT WAS EXPOSED TO RADIATION. DEFLATION OF THE LEFT EXPANDER WAS NOTICED AT THE TIME OF THE REMOVAL ON (B)(6) 2017.

  Patient problems: No Code Available

  MAUDE report 7375598 ↗
• InjuryMar 27, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER AND EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2016.

  Patient problems: No Code Available

  MAUDE report 7375326 ↗
• InjuryMar 7, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT BREAST RECONSTRUCTION WITH MENTOR CPX 4 BREAST TISSUE EXPANDER 8200, 550CC STYLE THAT FAILED TO RETAIN FLUID AFTER IMPLANTATION. THE TISSUE EXPANDER WAS INSIDE THE PATIENT FOR LONGER THAN SIX MONTHS DUE TO THE PATIENT REQUIRING EXTENDED CHEMOTHERAPY AND RADIATION TREATMENT. AS A RESULT, THE PATIENT SCHEDULED TO REPLACE IT WITH BREAST IMPLANT ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7319618 ↗

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