(UNDATED) – Cook Medical is recalling 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.
These fragments could potentially enter the patient’s bloodstream and result in serious adverse health consequences such as a longer procedure to retrieve the plastic pieces, injury to blood vessel walls, embolism, stroke, or death.
The Transseptal Needle 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.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Recalled Product(s): Transseptal needle
- Lot Number: 8833687
- Model: TSNC-18-71.0
- Manufacturing Date: April 23, 2018
- Distribution Dates: May 30, 2018 to November 5, 2018
- Devices Recalled in the U.S.: 97
Health care professionals and distributors with questions are instructed to contact Cook Medical Customer Relations by phone at 800-457-4500 or 812-339-2235, Monday through Friday between 7:30 A.M. and 5:00 P.M. (Eastern Time) or by email to CustomerRelationsNA@CookMedical.com.