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FDAMarch 30, 2017device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

thoratec

UPCs

00813024011286

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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