MENTOR CPX 4 Breast Tissue Expander 3548314Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00081317006619), received between Oct 19, 2018 and Mar 18, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Material Rupture” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18925387 ↗
• InjuryMar 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 56-YEAR-OLD CAUCASIAN FEMALE PATIENT UNDERWENT BREAST SURGERY WITH 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER AND EXPERIENCED EXPANDER DEFLATION ON HER LEFT SIDE POSTOPERATIVELY. AS A RESULT, THE EXPANDER WAS EXPLANTED ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18875919 ↗
• InjuryJan 2, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION SURGERY WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER. POST-OPERATIVELY, THE PATIENT EXPERIENCED A DEFLATION ON AN UNDISCLOSED SIDE, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 16084043 ↗
• InjuryJan 3, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER, EXPERIENCED ANOTHER RECURRENT SEROMA AND DISCOVERED TO HAVE A DEFLATED RIGHT SIDE EXPANDER DURING SURGERY. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2018.

  Patient problems: No Code Available; Seroma

  MAUDE report 8215120 ↗
• InjuryDec 21, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST SURGERY PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER 550CC DEVICE THAT DEFLATED AFTER IMPLANTATION. THE PATIENT WAS UNDERGOING EXPANSION PRIOR TO STARTING RADIATION THERAPY. A SCAN IN PREPARATION FOR THE RADIATION THERAPY IDENTIFIED FLUID BUILDUP AROUND THE TISSUE EXPANDER DEVICE. THE DEVICE APPEARED TO BE GOING DOWN, SO A LEAK WAS SUSPECTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH AN UNSPECIFIED DEVICE ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 8191902 ↗
• InjuryOct 19, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION REVISION WITH A MENTOR CPX 4 550CC BREAST TISSUE EXPANDER. DEFLATION ON THE LEFT BREAST TISSUE EXPANDER WAS OBSERVED POST PROCEDURE. THE PHYSICIAN STATES THERE WAS A HOLE WITHIN THE SEAM OF THE EXPANDER. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH A SIMILAR MENTOR CPX 4 550CC BREAST TISSUE EXPANDER ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7987461 ↗

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-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-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