HeartMate II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 00813024011224 Intended to provid

FDA device recall Z-2052-2017 · posted 2017-05-24 · Terminated

Recall details

Recalling firm

Thoratec Corporation

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

DSQ

Quantity affected

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

Date initiated

2017-03-30

Date posted

2017-05-24

Date terminated

2019-03-20

Location

Pleasanton, CA