MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549114Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00081317006688), received between Apr 30, 2018 and Mar 25, 2024 — classified as 7 injuries.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT BREAST AUGMENTATION WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED LEFT SIDED DEFLATION POST PROCEDURE. AS A RESULT, EXPLANT WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18975240 ↗
• InjurySep 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT PRIMARY BREAST SURGERY WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND AFTER THE CPX4 EXPANDER WAS TAKEN OUT FROM THE PATIENT'S CHEST, IT WAS NOTICEABLE THAT THE EXPANDER WAS DEFLATED IN THE MID OF EXPANSION. THE EXPANDER WAS WORKING FINE UNTIL THE LAST SESSION. WHEN THE SURGEON PRESSED THE EXPANDER WITH TWO HANDS, SHE WAS ABLE TO FIND OUT THAT IT WAS RUPTURED. AS A RESULT, THE EXPANDER WAS EXPLANTED ON AN UNKNOWN DATE. THE EXPANDER IS FILLED WITH SALINE, SO THERE WAS NO REPORTED IMPACT TO SURGERY OR PATIENT.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17752502 ↗
• InjuryMay 26, 2021Material Rupture; Material Rupture

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

  Patient problems: Hematoma; Post Operative Wound Infection; Seroma

  MAUDE report 11882826 ↗
• InjuryMar 31, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR OLD CAUCASIAN FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 550CC AND SUFFERED FROM A DEFLATION ON THE RIGHT SIDE. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH SILICONE BREAST IMPLANT ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11599859 ↗
• InjuryMar 15, 2019Material Rupture; Material Rupture

  IT WAS REPORTED (VIA MW5077693) THAT A PATIENT OF UNKNOWN AGE WHO UNDERWENT AN UNSPECIFIED IMPLANTATION PROCEDURE WITH A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER, EXPERIENCED RIGHT SIDE DEFLATION. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON AN UNSPECIFIED EXPLANTATION DATE.

  Patient problems: No Code Available

  MAUDE report 8426106 ↗
• InjuryJul 6, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT (B)(6) -YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 550CC AND EXPERIENCED DEFLATION ON THE RIGHT TISSUE EXPANDER. AS A RESULT, THE PATIENT HAD UNDERGONE REMOVAL AND REPLACEMENT WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 550CC ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7666330 ↗
• InjuryApr 30, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT PRIMARY BREAST RECONSTRUCTION WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 220CC. DEFLATION ON THE LEFT TISSUE EXPANDER WAS DIAGNOSED POST PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A MENTOR MEMORYSHAPE BREAST IMPLANT 480CC GEL PROSTHESIS ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7474698 ↗

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