HeartMate II Left Ventricular Assist System (HM II LVAS) Sealed Outflow Graft Bend Relief. The Sealed Outflow Graft Bend

FDA device recall Z-1228-2012 · posted 2012-03-23 · Terminated

Recall details

Recalling firm

Thoratec Corporation

Reason for recall

A trend of disconnected bend reliefs on the sealed outflow graft used with the HeartMate II LVAS has been identified

Action taken

Thoractec Corporation sent an Urgent Medical Device Correction letter on February 23, 2012 via overnight courier and e-mail to all affected consignees. The Urgent Medical Device Correction notification letters identify the affected products, description of the problem with illustrations, symptoms of problem and immediate actions to taken. All users are asked to review the attached labeling, including new caution statements and share with all surgical personnel. Consignees are instructed to completed and returned the Acknowledgement Form indicating that the information was received and understood. Additionally, an update concerning the Worldwide Medical Device Correction Notification is enclosed with each letter. Questions should be directed to Thoratec Regulatory Affairs at 925-847-8571.

Root cause

Device Design

Status

Terminated

Product code

DSQ

Quantity affected

3852 units in commerce

Distribution

Worldwide Distribution - USA (nationwide) and the countries of: Austria, Belgium, Denmark, Germany, Greece, France, Hong Kong, Kuwait, Ireland, Israel, Italy, Lebanon, Liechtenstein, Lithuania, Luxemb

Date initiated

2012-02-23

Date posted

2012-03-23

Date terminated

2012-11-08

Location

Pleasanton, CA