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U.S. Department of Health and Human Services

Class 1 Device Recall HeartMate II Left Ventricular Assist System (LVAS) with Pocket Controller

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  Class 1 Device Recall HeartMate II Left Ventricular Assist System (LVAS) with Pocket Controller see related information
Date Initiated by Firm March 30, 2017
Date Posted May 24, 2017
Recall Status1 Terminated 3 on March 20, 2019
Recall Number Z-2051-2017
Recall Event ID 76978
PMA Number P060040 
Product Classification Ventricular (assisst) bypass - Product Code DSQ
Product HeartMate¿ II LVAS with Pocket Controller;
107801 - HMII PUMP & POCKET CTRL ONLY
UDI:00813024011286

Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
Code Information All Serial numbers.
Recalling Firm/
Manufacturer		 Thoratec Corporation
6035 Stoneridge Dr
Pleasanton CA 94588-3270
For Additional Information Contact Krista Warner
651-756-2000
Manufacturer Reason
for Recall		 St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014.
FDA Determined
Cause 2		 Device Design
Action Urgent Medical Device Correction letters, dated March 29, 2017, were sent to customers. The letters provided information on what the current correction will involve to ensure patients are successfully able to exchange their pocket controller in an emergency situation. Patients will receive the updates at scheduled appointment. Questions regarding the notice, should be directed to Abbott HeartLine at 800-456-1477; or, your Abbott Sales Representative.
Quantity in Commerce 24,077 active units in US
Distribution Worldwide Distribution -- US and Austria, Belgium, Brazil, Canada, Cayman Islands, Chile, Columbia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Kazakhstan, Kuwait, Latvia, Lebanon, Liechtenstein, Lithuania, Malaysia, Orman, Palastine, Poland, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, The Netherlands, Turkey, United Arab Emirates, and United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = DSQ and Original Applicant = Abbott Medical
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