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HeartWare initiates partial recall of controllers

(Reuters) - HeartWare International Inc, a maker of implantable heart pumps for patients suffering from advanced heart failure, said it was initiating repairs and a partial recall of certain HeartWare controllers, which manages its HVAD pump.

The HeartWare controller sends power and operating signals to the HVAD pump while also providing information to the patient and physician via visual and audio feedback.

The company said it was recalling certain controllers to fix the volume level.

The implementation of the waterproof controllers last July generated an air-tight vacuum within the controller, resulting in reduced speaker volume in a small number of cases, the company said.

However, no patient has experienced any form of medical complications due to reduced volume level, the company added.

HeartWare expects the aggregate cost of implementing the voluntary repair and replacement project to be less than $400,000, inclusive of inventory, travel, freight and related costs, and expects the program to be completed within 30-60 days.

Wedbush analyst Duane Nash said in a note that the recall does not present a material risk to the company, even in the near-term.

Shares of HeartWare closed at $49.92 Friday on Nasdaq.

(Reporting by Jennifer Robin Raj in Bangalore; Editing by Jarshad Kakkrakandy)

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