MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549316Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00081317006824), received between Apr 3, 2018 and Feb 11, 2021 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (9 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.

• InjuryFeb 11, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT, WHO'S UNDERGONE BREAST RECONSTRUCTION WITH A 750CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS ON HE LEFT BREAST, SUFFERED LEFT BREAST IMPLANT DEFLATION, POST-PROCEDURE. AS A RESULT, THE PATIENT UNDERWENT IMPLANT EXPLANTATION ON (B)(6) 2021.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11317624 ↗
• InjuryJan 5, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT REVISION RECONSTRUCTION BREAST SURGERY WITH 750CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED DEFLATION ON HER RIGHT SIDE POSTOPERATIVELY. AS A RESULT, THE EXPANDER WAS EXPLANTED ON (B)(6) 2020.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11116297 ↗
• InjuryMay 31, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 750CC AND EXPERIENCED DEFLATION ON THE LEFT SIDE. AS A RESULT, THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH UNSPECIFIED PERMANENT IMPLANTS ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8660635 ↗
• InjuryMay 7, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 750CC DEVICE THAT DEFLATED AFTER IMPLANTATION. A PHYSICIAN CONFIRMED DEFLATION OF THE PATIENT¿S RIGHT SIDE TISSUE EXPANDER UPON EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8589292 ↗
• InjuryApr 6, 2019Material 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 750CC DEVICE THAT DEFLATED AFTER IMPLANTATION. DEFLATION OF THE RIGHT TISSUE EXPANDER WAS CONFIRMED BY A PHYSICIAN. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 750CC DEVICE ON (B)(6) 2018. THE EXPLANTED DEVICE WAS DISCARDED AFTER SURGERY.

  Patient problems: No Code Available

  MAUDE report 8489817 ↗
• MalfunctionNov 1, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 750CC HAD A HOLE WHEN THE BOX WAS OPENED. THE HOLE WAS DISCOVERED PRE-OPERATION SO THERE WAS NO PATIENT CONTACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8028892 ↗
• InjuryJun 19, 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 750CC WITH SUTURE TABS. DEFLATION OF THE LEFT BREAST TISSUE EXPANDER WAS DIAGNOSED VIA SELF-EXAMINATION AFTER PATIENT WOKE IN THE MORNING. AS A RESULT, THE BREAST TISSUE EXPANDER WAS REMOVED FROM THE PATIENT ON (B)(6) 2018 AND REPLACED WITH UNSPECIFIED IMPLANTS. ONCE REMOVED, IT WAS NOTED THAT THE TISSUE EXPANDER WAS LEAKING FROM THE POSTERIOR SURFACE OR BACK PLATE. THE FLEXHD WAS ALSO REMOVED SINCE IT WAS NOTED TO NOT BE INTEGRATED.

  Patient problems: No Code Available

  MAUDE report 7617160 ↗
• InjuryJun 6, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A PRIMARY BREAST AUGMENTATION PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 750 CC DEVICE THAT DEFLATED AFTER IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7574852 ↗
• InjuryJun 4, 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 750CC WITH SUTURE TABS. DEFLATION AND LEAKING ON THE RIGHT BREAST TISSUE EXPANDER WERE DIAGNOSED POST PROCEDURE THROUGH A PHYSICAL EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REMOVAL AND REPLACEMENT WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER 750CC WITH SUTURE TABS ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7565785 ↗
• InjuryApr 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 750CC DEVICE WHEN PATIENT DEVELOPED AN INFECTION. A SURGERY WAS PLANNED TO REMOVE THE TISSUE EXPANDER, BUT THE SURGEON DID NOT OPERATE BECAUSE THE PATIENT WAS KEPT IN THE HOSPITAL OVERNIGHT AND THE INFECTION SUBSIDED.

  Patient problems: Unspecified Infection

  MAUDE report 7394699 ↗

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