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SeQureTM Snare System

Lifetech Scientific (Shenzhen) Co., Ltd. · Model LT-SP-10 · UDI-DI 06938370118084

MMX Prescription

510(k) clearances

404

Adverse events (7 deaths)

Recalls

Facilities

Description

The SeQureTM Snare System consists of a snare, a catheter, a loader and a torquer. The snare is constructed of a nitinol shaft and a loop with the plane of the loop perpendicular to the nitinol shaft. The nitinol loop is covered with a tungsten coil which is coated by laminated titanium and its nitride to enhance radiopaque. The pre-formed snare loop can be introduced through catheter without risk of permanent deformiation because of super-elasticity of nitinol material. The catheter consists of luer connector and PE tubing with a radiopaque markband at its distal tip to enhance the visibility during the operation. The snare is pre-assembled with the loader and the torque, and then packaged together with corresponding catheter.

Recalls

Date	Firm	Reason
2014-07-17	Cook Inc.	This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire.

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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.