Recalls / —

—#154745

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.

FDA product code

DSQ — Ventricular (Assist) Bypass

Device class

Class 3

Medical specialty

Unknown

PMA numbers

P060040

Affected lot / code info

All Serial numbers.

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

Thoratec Corporation

Address

6035 Stoneridge Dr, Pleasanton, California 94588-3270

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2017-03-30

Posted by FDA

2017-05-24

Terminated

2019-03-20

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #154745. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.