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HeartWare Starts Partial Recall of Waterproof Controllers

DOW JONES NEWSWIRES HeartWare International Inc. (HTWR) announced a partial recall of some of its waterproof heartpump controllers that may have reduced speaker-volume levels owing to excess air vacuum in some of the units. The medical-device maker said a July design revision led to the excess air vacuum during air transports. Though the company expanded its product-testing in December of last year to screen out affected units and added a small Teflon vent to prevent the problem. The controllers are part of the HeartWare Left Ventricular Assist Systems, or heartpumps to treat advanced heart failure, which is limited to investigational use in the U.S. The device is available for commercial use in Europe. President and Chief Executive Doug Godshall said, "There are still patients being supported by our now waterproof controllers that do not have the current 'vented' controller. This field program will enable these older versions to be upgraded to the current vented configuration." HeartWare will also replace some other controllers. The company said the reduced volume doesn't otherwise impede the controllers' operation and that it has "significant inventory" of vented controllers and associated components to repair and replace the units without disruptions. The expected cost is less than $400,000, the company said. Shares closed Friday at $49.92 and were inactive premarket. The stock is up 41% this year. -By Tess Stynes, Dow Jones Newswires; 212-416-2481;

Stock News for Heartware International (HTWR)
05/23/201616:56:21Statement of Ownership (sc 13g)
05/05/201617:41:22Quarterly Report (10-q)
05/05/201616:15:00HeartWare Presentation At The Bank Of America Merrill Lynch 2016...
05/05/201606:04:09Amended Statement of Beneficial Ownership (sc 13d/a)
05/04/201607:16:51Current Report Filing (8-k)
05/04/201607:00:00HeartWare International Reports First Quarter 2016 Financial...
05/02/201619:26:07Statement of Changes in Beneficial Ownership (4)
05/02/201619:25:12Statement of Changes in Beneficial Ownership (4)
05/02/201619:24:44Statement of Changes in Beneficial Ownership (4)
05/02/201619:23:49Statement of Changes in Beneficial Ownership (4)
05/02/201619:23:14Statement of Changes in Beneficial Ownership (4)
05/02/201619:22:19Statement of Changes in Beneficial Ownership (4)
05/02/201619:20:44Statement of Changes in Beneficial Ownership (4)
04/29/201607:32:27Proxy Statement (definitive) (def 14a)
04/27/201616:00:00HeartWare Completes Enrollment In HVAD® System LATERAL Study™
04/20/201609:00:00HeartWare Announces HVAD® System Scientific Presentations At...
04/19/201616:00:00HeartWare Schedules First Quarter 2016 Financial Results Conference...
04/04/201617:03:37Statement of Changes in Beneficial Ownership (4)
03/21/201611:56:00March 22 Deadline Alert: Law Offices of Howard G. Smith Reminds...
03/21/201611:49:05INVESTOR ALERT: The Law Offices of Vincent Wong Remind Investors...

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