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Mentor CPX4 with suture tabs, med height, smooth

MENTOR TEXAS L.P. · Model 3509214 · UDI-DI 00081317026679

LCJ Prescription
1
510(k) clearances
5,172
Adverse events (4 deaths)
21
Recalls
22
Facilities

Description

Breast tissue expander, suture tabs, smooth, integral injection dome, 550CC

Recalls

DateFirmReason
2026-02-18Mentor Texas, LP.Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
2026-02-18Mentor Texas, LP.Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
2026-02-18Mentor Texas, LP.Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
2026-02-18Mentor Texas, LP.Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
2026-02-18Mentor Texas, LP.Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
2026-02-18Mentor Texas, LP.Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
2026-02-18Mentor Texas, LP.Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
2026-02-02B Braun Medical IncThe potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
2026-02-02B Braun Medical IncThe potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
2026-02-02B Braun Medical IncThe potential for the needle tip to be dull/blunt, difficult to advance, and/or break.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.