MENTOR CPX4 PLUS, Smooth, Medium Height SCPX127MHRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10081317028373), received between Sep 13, 2022 and May 1, 2026 — classified as 7 injuries, 6 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 18, 2026Class IIOpen, Classified

   Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.

   Z-1683-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Material Rupture

  IT WAS REPORTED THAT A 450CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT BREAST IMPLANT EXPANDER HAD LEAKED. NO ADVERSE EVENTS, PATIENT HARMS, OR PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED. FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058630 ↗
• MalfunctionJan 3, 2025Material Rupture; Material Rupture

  A FEMALE PATIENT WHO UNDERWENT AN UNSPECIFIED BREAST SURGERY USING A MENTOR CPX4 PLUS SMOOTH, MEDIUM-HEIGHT 450CC SALINE PROSTHESIS EXPERIENCED PREIMPLANTATION DEFLATION ON AN UNKNOWN SIDE. FORTUNATELY, THE PATIENT WAS NOT ADVERSELY AFFECTED AS A BACKUP EXPANDER WAS AVAILABLE. NO ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21074394 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED (VIA MEDSUN (B)(4)) THAT A PATIENT UNDERWENT AN ATAXIA-TELANGIECTASIS MUTATED (ATM) MUTATION SURGERY FOR PROPHYLACTIC BILATERAL MASTECTOMY WITH MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT 450CC TISSUE EXPANDERS PRESENTED WITH A LARGE FLUID COLLECTION ON HER RIGHT CHEST WALL POST IMPLANTATION. ADDITIONALLY, THE PATIENT DEVELOPED NECROSIS ON THE MASTECTOMY FLAP. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION OF THE RIGHT BREAST TISSUE EXPANDER ON AN UNKNOWN DATE. ON A LATER DATE, THE PATIENT PRESENTED WITH FLUID ON HER LEFT CHEST WALL AND UNDERWENT DRAINAGE OF THE FLUID. THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT AGAIN AND 11.7 CM FLUID WAS DETECTED WITH ULTRASOUND. THE PATIENT UNDERWENT DRAINAGE OF BILATERAL BREAST SEROMAS AND PLACEMENT OF 19 FRENCH DRAIN ON AN UNKNOWN DATE. AFTER HEALING, THE PATIENT UNDERWENT SURGERY FOR DELAYED INSERTION OF A MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT 450CC TISSUE EXPANDER IN HER RIGHT BREAST ON AN UNKNOWN DATE. THE PATIENT LATER DEVELOPED PAIN AND REDNESS IN HER LEFT BREAST ON AN UNKNOWN DATE. AS A RESULT OF THE ABOVE, THE PATIENT UNDERWENT BILATERAL REMOVAL OF THE TISSUE EXPANDERS ON AN UNKNOWN DATE. THE PATIENT PRESENTED AT

  Patient problems: Necrosis; Seroma

  MAUDE report 20091293 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED (VIA MEDSUN (B)(4)) THAT A PATIENT UNDERWENT AN ATAXIA-TELANGIECTASIS MUTATED (ATM) MUTATION SURGERY FOR PROPHYLACTIC BILATERAL MASTECTOMY WITH MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT 450CC TISSUE EXPANDERS PRESENTED WITH A LARGE FLUID COLLECTION ON HER RIGHT CHEST WALL POST IMPLANTATION. ADDITIONALLY, THE PATIENT DEVELOPED NECROSIS ON THE MASTECTOMY FLAP. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION OF THE RIGHT BREAST TISSUE EXPANDER ON AN UNKNOWN DATE. ON A LATER DATE, THE PATIENT PRESENTED WITH FLUID ON HER LEFT CHEST WALL AND UNDERWENT DRAINAGE OF THE FLUID. THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT AGAIN AND 11.7 CM FLUID WAS DETECTED WITH ULTRASOUND. THE PATIENT UNDERWENT DRAINAGE OF BILATERAL BREAST SEROMAS AND PLACEMENT OF 19 FRENCH DRAIN ON AN UNKNOWN DATE. AFTER HEALING, THE PATIENT UNDERWENT SURGERY FOR DELAYED INSERTION OF A MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT 450CC TISSUE EXPANDER IN HER RIGHT BREAST ON AN UNKNOWN DATE. THE PATIENT LATER DEVELOPED PAIN AND REDNESS IN HER LEFT BREAST ON AN UNKNOWN DATE. AS A RESULT OF THE ABOVE, THE PATIENT UNDERWENT BILATERAL REMOVAL OF THE TISSUE EXPANDERS ON AN UNKNOWN DATE. THE PATIENT PRESENTED AT

  Patient problems: Local Reaction; Seroma

  MAUDE report 20091119 ↗
• MalfunctionJul 10, 2024Material Rupture; Appropriate Device Problem Term/Code Not Available; Material Rupture; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER DEFLATED DURING AN UNSPECIFIED BREAST SURGERY PRIOR TO BEING IMPLANTED INTO THE PATIENT. IT WAS ALSO REPORTED THAT THE DAMAGE TO THE DEVICE WAS CAUSED BY THE PHYSICIAN. HOWEVER, THE SURGERY COMMENCED WITHOUT ANY REPORTED DELAYS AND A NEW IMPLANT WAS USED TO COMPLETE THE IMPLANTATION. NO REPORTED ADVERSE EVENTS OR PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19714745 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION WITH TWO 450CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDERS. POST-OPERATIVELY, THE PATIENT SUFFERED INFECTION. THE SYMPTOMS WERE FEVER, BODY ACHES, NAUSEA, BREAST REDNESS, WARMTH, INCREASE PAIN AND SWELLING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6) 2024. SPECIMEN WERE ALSO COLLECTED FOR CULTURE. THE REPLACEMENT DEVICES: (LEFT) 550CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT, CATALOG: SCPX135MH, LOT: 9584083, SN: (B)(6) AND (RIGHT) 550CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT, CATALOG: SCPX135MH, LOT: 9808686 SN: (B)(6). THIS MEDWATCH FORM IS FOR THE RIGHT BREAST PROSTHESIS.

  Patient problems: Post Operative Wound Infection; Seroma

  MAUDE report 19568628 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST RECONSTRUCTION WITH TWO 450CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT TISSUE EXPANDERS. POST-OPERATIVELY, THE PATIENT SUFFERED INFECTION. THE SYMPTOMS WERE FEVER, BODY ACHES, NAUSEA, BREAST REDNESS, WARMTH, INCREASE PAIN AND SWELLING. AS A RESULT, THE PATIENT UNDERWENT BILATERAL BREAST IMPLANT REMOVAL AND REPLACEMENT SURGERY ON (B)(6), 2024. SPECIMEN WERE ALSO COLLECTED FOR CULTURE. THE REPLACEMENT DEVICES: (LEFT) 550CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT CATALOG: SCPX135MH LOT: 9584083 SN: (B)(6) AND (RIGHT) 550CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT CATALOG: SCPX135MH LOT: 9808686 SN: (B)(6).THIS MEDWATCH FORM IS FOR THE LEFT BREAST PROSTHESIS.

  Patient problems: Post Operative Wound Infection; Seroma

  MAUDE report 19568627 ↗
• InjuryFeb 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 450CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT PROSTHESIS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT BREAST IMPLANT BY AN UNDISCLOSED METHODOLOGY. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL ON (B)(6) 2024. THE DATE OF IMPLANTATION AND EVENT WERE NOT PROVIDED TO MENTOR AS A BEST ESTIMATE. SEVERAL FOLLOW-UPS HAVE BEEN CONDUCTED, AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. IF MORE INFORMATION BECOMES AVAILABLE, MENTOR WILL SUBMIT A SUPPLEMENTAL REPORT ACCORDINGLY.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 18707793 ↗
• MalfunctionSep 26, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 450CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT PROSTHESIS WAS OBSERVED TO HAVE A HOLE DURING THE PRE-OPERATIVE PREPARATION. THE IMPLANT DID NOT COME INTO CONTACT WITH THE PATIENT AND THERE WERE NO ADVERSE EVENTS OR PATIENT CONSEQUENCES. THE SURGERY COMMENCED WITH THE USE OF A NEW IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17818926 ↗
• InjurySep 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE WHO UNDERWENT AN UNKNOWN BREAST RECONSTRUCTION SURGERY WITH A MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT, TISSUE EXPANDER BREAST IMPLANT EXPERIENCED UNKNOWN-SIDED DEFLATION POST PROCEDURE. AS A RESULT, PATIENT UNDERWENT REPLACEMENT WITH UNKNOWN IMPLANT ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 17782075 ↗
• MalfunctionJul 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT A 450CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT HAD A HOLE PRE-OPERATIVELY, DURING A BREAST IMPLANTATION SURGERY. THERE WAS NO REPORT OF ADVERSE EVENT OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17312068 ↗
• MalfunctionFeb 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BEFORE THE 450CC MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT COULD BE IMPLANTED INTO THE PATIENT, THE HEALTH CARE PROFESSIONAL NOTICED A TINY HOLE ON THE DEVICE. PATIENT WAS ALREADY ON THE TABLE BUT DEVICE HAD NO CONTACT TO PATIENT AND NO DELAY TO SURGERY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16414134 ↗
• InjurySep 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN UNSPECIFIED BREAST SURGERY WITH A MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT 450CC TISSUE EXPANDER THAT DEFLATED POST IMPLANTATION. THE DEFLATION WAS OBSERVED DURING EXPLANTATION SURGERY ON (B)(6) 2022.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 15412863 ↗