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Integra

PMT CORPORATION · Model 3614ES-13-2-ST · UDI-DI 00650551001973

LCJ Prescription

510(k) clearances

5,147

Adverse events (4 deaths)

Recalls

Facilities

Description

TISSUE EXPANDER, CURVE SHAPE, ENHANCED SURFACE, REMOTE PORT, SUTURE TABS, 2-STAGE, 2.5X5CM, 60C FILL VOLUME, 4CM PROJECTION

Recalls

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