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# Cook Medical Recalls Transseptal Needle
- URL: https://www.fdaweb.com/cook-medical-recalls-transseptal-needle-2/
- Published: 2019-03-18T12:00:00.000Z
- Updated: 2026-09-15T01:13:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143632

Cook Medical has begun recalling (Class 1) one lot of the Transseptal Needle due to a manufacturing error that resulted in some needle tips missing the back bevel that creates a sharp tip. “Without a back bevel, the needle tip could damage the inside of the introducer sheath during insertion of the needle resulting in detached plastic fragments,” a recall notice says. The fragments could potentially enter the bloodstream and result in serious adverse health consequences, it says. The device is used by surgeons to access the left side of a patient’s heart during cardiac procedures. Fluoroscopy medical imaging and a guide catheter help the surgeon place the needle in the heart.