MENTOR CPX 3 Breast Tissue Expander with Suturing Tabs 3547212Recalls & reported problems
Mentor Texas L.P. · SILTEX Medium Height Tissue Expander Style 7200, 350cc · Class U · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00081317003670), received between Feb 20, 2018 and Feb 20, 2018 — classified as 1 injury.
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
- Material Rupture1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2018Material Rupture; Material Rupture
IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT WHO UNDERWENT RECONSTRUCTION WITH MENTOR TISSUE EXPANDER IN (B)(6) ON (B)(6) 2015 EXPERIENCED DEFLATION OF DEVICE THAT WAS OBSERVED ON (B)(6) 2017. THE PATIENT UNDERWENT REMOVAL AND REPLACEMENT WITH OTHER MENTOR TISSUE EXPANDER ON(B)(6) 2018. PER MENTOR IFU, THIS DEVICE SHOULD NOT BE IMPLANTED ANYTIME EXCEEDING 6 MONTHS. HENCE, THIS WAS AN OFF LABEL USE OFF DEVICE AS IT WAS IMPLANTED FOR 2 YEARS AND 8 MONTHS.
Patient problems: No Code Available
MAUDE report 7284647 ↗
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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