MENTOR CPX4 PLUS, Smooth, Tall Height SCPX132THRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10081317028441), received between Apr 19, 2022 and Nov 25, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (7 reports).

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.

• InjuryNov 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PROCEDURE WITH A MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT 550CC TISSUE EXPANDER THAT DEFLATED POST IMPLANTATION. DEFLATION OF THE PATIENT¿S LEFT TISSUE EXPANDER WAS REPORTED. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT 550CC TISSUE EXPANDER ON (B)(6) 2025.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 23651088 ↗
• InjuryMay 14, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT 550CC TISSUE EXPANDER WHEN THE LEFT BREAST DEVICE DEFLATED POST IMPLANTATION. UPON EXPLANTATION, A SMALL OPENING ON THE POSTERIOR EDGE WHERE THE BACK PATCH AND THE SHELL MEET WAS OBSERVED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 22022132 ↗
• InjurySep 12, 2024Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  IT WAS REPORTED THAT A 550CC MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT DEFLATED, AND DELAMINATED DEVICE WAS REMOVED ON (B)(6) 2024 AND ACCIDENTALLY DISCARDED. PHOTOS WERE TAKEN. NO OTHER DETAILS ARE AVAILABLE AT THIS TIME. FOLLOW UPS ARE BEING PERFORMED FOR CLARIFICATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE UPDATED AND SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20200222 ↗
• MalfunctionJun 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT UPON OPENING OF THE DEVICE PACKAGING OF A 550CC MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT TISSUE EXPANDER, THE DEVICE WAS OBSERVED TO BE DEFLATED. THE EVENT OCCURRED PRE-OPERATIVELY, AND THE DEVICE DID NOT COME IN CONTACT WITH THE PATIENT. THERE WERE NO REPORTED ADVERSE EVENTS OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17082889 ↗
• InjuryNov 17, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT WHO UNDERWENT AN UNKNOWN BREAST SURGERY WITH AN UNKNOWN MENTOR TISSUE EXPANDER BREAST IMPLANTS HAS EXPERIENCED LEFT-SIDED DEFLATION POSTOPERATIVE. AS A RESULT, PATIENT UNDERWENT BILATERAL REPLACEMENT WITH LEFT/ CATALOG NUMBER 3505004BC, SERIAL NUMBER (B)(4), RIGHT SIDE- UNKNOWN ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15816336 ↗
• InjurySep 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST IMPLANTATION WITH UNSPECIFIED MENTOR TISSUE EXPANDERS AND EXPERIENCED DEFLATION (SIDE UNKNOWN) POST-OPERATIVELY. INFORMATION RECEIVED INDICATES THE PATIENT UNDERWENT REMOVAL OF THE DEVICE, BUT THE EXACT DATE OF EXPLANTATION IS UNKNOWN.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15381255 ↗
• InjuryApr 19, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT UNSPECIFIED BREAST SURGERY WITH UNKNOWN SIZE UNKNOWN TISSUE EXPANDERS AND EXPERIENCED UNKNOWN SIDE EXPANDER DEFLATION. AS A RESULT, THE DEVICE WAS EXPLANTED ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 14144580 ↗