MENTOR CPX 2 Breast Tissue Expander 3546212Recalls & reported problems
Mentor Texas L.P. · SITLEX Medium Height Tissue Expander Style 6200, 350cc · Class U · Implant
All models of MENTOR CPX 2 Breast Tissue Expander (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00081317002253), received between Jul 16, 2019 and Jul 16, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (1 report).
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
Device problems
- No Apparent Adverse Event2
- Adverse Event Without Identified Device or Use Problem1
- Material Rupture1
Patient problems
- No Code Available2
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WITH MENTOR CPX 2 BREAST TISSUE EXPANDERS 350CC AND EXPERIENCED SICKNESS, LOSS OF MOVEMENT ON THE RIGHT SIDE, NECK PAIN, BACK PAIN, AND DEFLATION ON THE RIGHT SIDE. THE DEFLATION WAS DISCOVERED DURING EXPLANTATION ON (B)(6) 2019. IT IS UNKNOWN WHICH SIDE EACH DEVICE CORRESPONDS TO. THIS REPORT HAS BEEN DEFAULTED TO THE LEFT SIDE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING DEVICE INFORMATION, A SUPPLEMENTAL WILL BE SUBMITTED.
Patient problems: No Code Available; No Patient Involvement
MAUDE report 8795168 ↗MalfunctionJul 16, 2019Material Rupture; No Apparent Adverse Event; Material Rupture; No Apparent Adverse Event
IT WAS REPORTED THAT A (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WITH MENTOR CPX 2 BREAST TISSUE EXPANDERS 350CC AND EXPERIENCED SICKNESS, LOSS OF MOVEMENT ON THE RIGHT SIDE, NECK PAIN, BACK PAIN, AND DEFLATION ON THE RIGHT SIDE. THE DEFLATION WAS DISCOVERED DURING EXPLANTATION ON (B)(6) 2019. IT IS UNKNOWN WHICH SIDE EACH DEVICE CORRESPONDS TO. THIS REPORT HAS BEEN DEFAULTED TO THE RIGHT SIDE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING DEVICE INFORMATION, A SUPPLEMENTAL WILL BE SUBMITTED.
Patient problems: No Code Available; No Patient Involvement
MAUDE report 8795158 ↗
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
- 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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