Class I Recall of Transseptal Needle by Cook Medical, Inc.

PUBLISHED: Mar 19, 2019
Relevant to: Ambulatory Care, Critical Access Hospitals, Hospitals

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.

Recalled Product Information:

  • 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

On February 1, 2019, Cook Inc. sent an Urgent Medical Device Recall notification letter to affected customers. The notice asked customers to:

  • Share notice with appropriate staff
  • Identify and remove any affected transseptal needles and quarantine affected needles
  • Immediately stop all distribution and use of affected products
  • Return any affected product(s) to Cook Inc. Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit
  • Complete and return the Acknowledgement and Receipt Form by fax at 812.339.7316 or email at FieldActionsNA@CookMedical.com

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