Thoratec Implantable Ventricular Assist Device (IVAD pump) (Component of Thoratec Ventricular Assist Device (VAD) System

FDA device recall Z-0212-2008 · posted 2007-11-21 · Terminated

Recall details

Recalling firm

Thoratec Corp

Reason for recall

Pneumatic Leaks: air leaks developing in the pneumatic driveline when subjected to excessive stress at the junction of the percutaneous line to the pump housing due to sharp bending when implanted (paracorporeal-external-position).

Action taken

An initial communication was sent to all affected IVAD customers on October 19, 2007, in the form of an "Urgent: Medical Device Correction" notice informing them of the problem. The correction notice requests that its customers/physicians take the following actions: 1) Contact all ongoing patients with IVADs placed in the paracorporeal position to evaluate the percutaneous line adjacent to the pump housing to ensure that it is not subject to extreme flexing or bending at acute angles. 2) Remind implanting surgeons and support staff of proper percutaneous line management and provide the patient with a copy of the recall information provided. Complete and sign an Acknowledgement form and fax it to Thoratec Regulatory Affairs. This is a User Level Recall. The firm also issued a November 7, 2007, Press Statement- Urgent Thoratec Corporation Worldwide Recall of Implantable Ventricular Assist Device.

Root cause

Device Design

Status

Terminated

Product code

DSQ

Quantity affected

766

Distribution

Worldwide: USA including states of AL,AR,AZ,CA,CO, FL,GA, IA,IL, IN,KS,KY,LA, MA, MD, ME,MI, MN, MO,NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI and to the following countries: Austria, Cana

Date initiated

2007-10-19

Date posted

2007-11-21

Date terminated

2009-05-26

Location

Pleasanton, CA