AUDIENCE: Risk Manager, Surgery, Cardiology

ISSUE: FDA notified healthcare professionals of
a Class I recall of the St. Jude Medical, AMPLATZER TorqVue FX Delivery System.
In a small number of cases, the distal end of the core wire of the TorqVue FX
Delivery System could potentially fracture when exposed to a combination of
certain cardiac anatomies and usage conditions.

This recall is for all batches
and model numbers of the AMPLATZER TorqVue FX Delivery System. The affected
product was manufactured August 24, 2012 to September 24, 2012 and distributed
October 1, 2012 – January 9, 2013. See the Recall Notice for a listing of model
numbers

BACKGROUND: The Amplatzer TorqVue FX Delivery System
is used to assist the attachment, loading, delivery, and deployment of
Amplatzer Occluder devices. Amplatzer Occluder devices are used to close
openings between the two upper chambers of the heart.

RECOMMENDATION: On January 17, 2013, St. Jude Medical sent an “Urgent Medical Device Recall Notice” to their customers. The letter advised customers to stop using the device and remove it from their inventory. St. Jude Medical plans to have their sales representatives perform site visits to assist with recall activities, including completion of the product reconciliation form and return of any unused product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Read the MedWatch safety alert, including a link to the Recall Notice, at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm339593.htm