MENTOR CPX 4 Breast Tissue Expander with Suture TabsRecalls & reported problems across all models
Mentor Texas L.P. · 19 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one MENTOR CPX 4 Breast Tissue Expander with Suture Tabs model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 299
- Deaths reported
- 0
- Injuries reported
- 259
- Recalls
- 1
We found 19 models of MENTOR CPX 4 Breast Tissue Expander with Suture Tabs by Mentor Texas L.P. in the FDA's device registry (GUDID). Together they are named in 299 adverse event reports in the FDA's MAUDE database, received between Feb 14, 2018 and Sep 30, 2026 — classified as 259 injuries, 40 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (214 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
MENTOR CPX 4 Breast Tissue Expander with Suture Tabs recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 18, 2026Class IIOpen, Classified
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Z-1681-2026 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
Most reported MENTOR CPX 4 Breast Tissue Expander with Suture Tabs problems
Device problems
- Material Rupture214
- Adverse Event Without Identified Device or Use Problem61
- Off-Label Use20
- Migration7
- Inflation Problem5
- Infusion or Flow Problem4
- Appropriate Device Problem Term/Code Not Available3
- Use of Device Problem3
Patient problems
- Deformity/ Disfigurement104
- No Code Available101
- No Clinical Signs, Symptoms or Conditions28
- Post Operative Wound Infection26
- No Consequences Or Impact To Patient12
- Capsular Contracture11
- Seroma10
- Unspecified Infection9
MENTOR CPX 4 Breast Tissue Expander with Suture Tabs models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549314EXPANDER, SKIN, INFLATABLE1 recall22 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549113EXPANDER, SKIN, INFLATABLE1 recall7 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549214EXPANDER, SKIN, INFLATABLE57 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549213EXPANDER, SKIN, INFLATABLE52 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549215EXPANDER, SKIN, INFLATABLE34 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549212EXPANDER, SKIN, INFLATABLE21 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549216EXPANDER, SKIN, INFLATABLE19 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549313EXPANDER, SKIN, INFLATABLE19 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549315EXPANDER, SKIN, INFLATABLE15 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549211EXPANDER, SKIN, INFLATABLE10 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549316EXPANDER, SKIN, INFLATABLE10 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549112EXPANDER, SKIN, INFLATABLE7 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549114EXPANDER, SKIN, INFLATABLE7 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549312EXPANDER, SKIN, INFLATABLE6 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549111EXPANDER, SKIN, INFLATABLE3 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549115EXPANDER, SKIN, INFLATABLE3 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549317EXPANDER, SKIN, INFLATABLE3 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549116EXPANDER, SKIN, INFLATABLE2 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549311EXPANDER, SKIN, INFLATABLE2 reports
Recent MENTOR CPX 4 Breast Tissue Expander with Suture Tabs adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Migration
Patient problems: Deformity/ Disfigurement
MAUDE report 50954114 ↗InjurySep 30, 2026Migration
Patient problems: Deformity/ Disfigurement
MAUDE report 50954108 ↗InjuryJul 30, 2026Material Rupture
It was reported that a patient underwent a Breast Reconstruction Revision Surgery with implantation of a 450cc MENTOR CPX 4 Breast Tissue Expander with Suture Tabs. Post-operatively, the patient was diagnosed with a deflated left expander using Ultrasound Imaging. As a result, the patient underwent left-sided exchange with a Mentor tissue expander on June 29, 2026.
Patient problems: Deformity/ Disfigurement
MAUDE report 50091194 ↗MalfunctionMay 21, 2026Material Rupture
IT WAS REPORTED THAT A 550CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS BEING USED IN A BREAST AUGMENTATION PROCEDURE WOULD NOT STAY FILLED DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. THE SURGEON USED A BACKUP DEVICE AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25244063 ↗InjuryApr 16, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST SURGERY WITH IMPLANTATION OF A 275CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH A DEFLATED LEFT IMPLANT DURING A PHYSICAL EXAM AS THE IMPLANT HAD A NOTICEABLY DECREASED VOLUME. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE. 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 24896440 ↗InjuryMar 9, 2026Material Rupture
IT WAS REPORTED THAT A PATIENT WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT DEVICE REMOVAL.
Patient problems: Deformity/ Disfigurement
MAUDE report 24552168 ↗InjuryMar 6, 2026Material Rupture
A FEMALE PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION WITH MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS 550CC, SALINE PROSTHESIS EXPERIENCED LEFT SIDED DEFLATION POSTOPERATIVELY. THE ISSUE WAS CONFIRMED THROUGH MRI EXAMINATION. AS A RESULT, THE PATIENT UNDERWENT UNILATERAL REPLACEMENT WITH LEFT: SN (B)(6) / CAT: 3549214 ON (B)(6), 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 24532717 ↗InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A BREAST RECONSTRUCTION REVISION PROCEDURE WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS DEVICE DEVELOPED INFLAMMATION/IRRITATION/SWELLING IN HER LEFT BREAST POST IMPLANTATION. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION AND REPLACEMENT WITH A MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS DEVICE.
Patient problems: Local Reaction
MAUDE report 24474583 ↗MalfunctionFeb 25, 2026Material Rupture
IT WAS REPORTED THAT A CUSTOMER RECEIVED A DEFECTIVE MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS TISSUE EXPANDER. THE DEVICE DID NOT HAVE ANY AIR AND APPEARED TO BE COMPLETELY FLAT. THE DEVICE WAS NOT USED IN ANY SURGERY AND THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24447074 ↗MalfunctionDec 19, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS WAS OBSERVED TO BE PUNCTURED WHEN THE PACKAGE WAS OPENED PRE-OPERATIVELY. NO PATIENT INVOLVEMENT WAS INDICATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23851092 ↗MalfunctionDec 19, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS DEFLATED DURING A PRIMARY BREAST RECONSTRUCTION SURGERY. HOWEVER, THE SURGERY COMMENCED WITHOUT ANY REPORTED DELAYS AND A NEW IMPLANT WAS USED TO COMPLETE THE IMPLANTATION. NO ADVERSE EVENTS, PATIENT HARMS, OR PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23850815 ↗InjuryDec 8, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS EXPERIENCED A DEFLATION ON THE LEFT SIDE POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025.
Patient problems: Deformity/ Disfigurement
MAUDE report 23747158 ↗InjuryNov 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT BREAST PROTHESIS IMPLANTATION SURGERY WITH A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS ON AN UNSPECIFIED BREAST SIDE. POST-OPERATIVELY, THE PATIENT WAS DIAGNOSED WITH BREAST INFECTION. AS A RESULT, THE PATIENT UNDERWENT BREAST IMPLANT REMOVAL SURGERY ON AN UNSPECIFIED DATE.
Patient problems: Post Operative Wound Infection
MAUDE report 23627077 ↗InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WITH MENTOR CPX 4 BREAST TISSUE EXPANDERS WITH SUTURE TABS EXPERIENCED INFECTION (SIDE UNKNOWN) POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AT THE TIME OF THIS REPORT, MENTOR HAS RECEIVED NO INFORMATION REGARDING EXPLANTATION OR AN EXPECTED EXPLANTATION DATE.
Patient problems: Post Operative Wound Infection
MAUDE report 23607246 ↗InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A BREAST SURGERY WITH A 450CC MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS AND EXPERIENCED AN INFECTION AFTER SURGERY POST-OPERATIVELY. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON AN UNDISCLOSED DATE.
Patient problems: Post Operative Wound Infection
MAUDE report 23599715 ↗
Other Mentor Texas L.P. products
- MENTOR MemoryGel Breast Implants368 models · 56,155 reports
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- MENTOR MemoryGel Xtra Breast Implant88 models · 5,679 reports
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- MENTOR MemoryShape Breast Implant65 models · 1,595 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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