MENTOR CPX4 PLUS, Smooth, Tall Height SCPX113THRecalls & reported problems
Mentor Texas L.P. · Breast Tissue Expander, Suture Tabs, Integral Injection Dome, 350CC · Class U · Implant
All models of MENTOR CPX4 PLUS, Smooth, Tall Height (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10081317028427), received between Mar 25, 2024 and Dec 30, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (3 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.
Reports received per month
Recalls naming this device
- Feb 18, 2026Class IIOpen, Classified
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
Z-1684-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Rupture3
Patient problems
- Deformity/ Disfigurement2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 30, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT A 16-YEAR-OLD FEMALE PATIENT UNDERWENT A PRIMARY BREAST RECONSTRUCTION WITH A 350CC MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT TISSUE EXPANDER AND EXPERIENCED A DEFLATION ON THE RIGHT SIDE POST-OPERATIVELY, WHICH WAS DIAGNOSED WITH AN OFFICE VISIT. AS A RESULT, THE PATIENT UNDERWENT EXPLANTATION ON (B)(6) 2025, AND REPLACED WITH A 350CC MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT TISSUE EXPANDER.
Patient problems: Deformity/ Disfigurement
MAUDE report 23927172 ↗MalfunctionMar 27, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A 350CC MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT TISSUE EXPANDER WAS IDENTIFIED TO HAVE A SMALL LEAK, PRE-IMPLANTATION. THE LEAK IS LOCATED WHERE THE PORT MEETS THE BUFFER ZONE OF THE IMPLANT. THERE WAS REPORTED TO BE A FIFTEEN MINUTE DELAY. A NEW BACKUP EXPANDER WAS IMPLANTED INSTEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18989362 ↗InjuryMar 25, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST RECONSTRUCTION PRIMARY WITH A MENTOR CPX4 PLUS, SMOOTH, TALL HEIGHT TISSUE EXPANDER AND EXPERIENCED DEFLATION ON THE LEFT SIDE POST-OPERATIVELY, WHICH WAS CONFIRMED DURING A PHYSICAL EXAM. AS A RESULT, THE PATIENT UNDERWENT REMOVAL ON (B)(6) 2024.
Patient problems: Deformity/ Disfigurement
MAUDE report 18975111 ↗
Other Expander, skin, inflatable devices
- B.BRAUN 7B3050B. Braun Medical Inc. · EXPANDER, SKIN, INFLATABLE1 recall40 reports
- MENTOR CPX 4 Breast Tissue Expander with Suture Tabs 3549314Mentor Texas L.P. · EXPANDER, SKIN, INFLATABLE1 recall22 reports
- MENTOR CPX4 PLUS, Smooth, Medium Height SCPX146MHMentor Texas L.P. · Expander, skin, inflatable1 recall18 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MX-13-TAllergan, Inc. · Expander, Skin, Inflatable1 recall16 reports
- MENTOR ARTOURA PLUS, Smooth, Ultra High Profile SDC135UHMentor Texas L.P. · Expander, skin, inflatable1 recall14 reports
- MENTOR ARTOURA PLUS, Smooth, High Profile SDC150HMentor Texas L.P. · Expander, skin, inflatable1 recall14 reports
- MENTOR ARTOURA PLUS, Smooth, Ultra High Profile SDC120UHMentor Texas L.P. · Expander, skin, inflatable1 recall14 reports
- Natrelle® Style 133 Tissue Expanders with Suture Tabs 133MV-14-TAllergan, Inc. · Expander, Skin, Inflatable1 recall13 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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