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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)
08/27/201517:05:31Statement of Changes in Beneficial Ownership (4)
08/10/201508:00:00HeartWare Completes Enrollment In ENDURANCE2 Supplemental Destination...
08/04/201512:16:00HeartWare Presentation At The Canaccord Genuity 35th Annual Growth...
08/04/201511:34:00Statement of Changes in Beneficial Ownership (4)
08/03/201517:10:34Quarterly Report (10-q)
07/30/201507:17:29Current Report Filing (8-k)
07/30/201507:00:00HeartWare International Reports $73.6 Million In Second Quarter...
07/23/201517:34:03Statement of Changes in Beneficial Ownership (4)
07/21/201508:00:00HeartWare Schedules Second Quarter 2015 Conference Call And Webcast
07/20/201509:33:55Current Report Filing (8-k)
07/20/201507:00:00HeartWare International Announces First Human Implants Of The...
07/13/201517:18:26Statement of Changes in Beneficial Ownership (4)
07/02/201517:05:37Statement of Changes in Beneficial Ownership (4)
06/29/201517:02:07Current Report Filing (8-k)
06/25/201517:06:00Statement of Changes in Beneficial Ownership (4)
06/08/201517:30:00HeartWare International Issues Voluntary Device Correction
06/05/201517:06:25Statement of Changes in Beneficial Ownership (4)
06/05/201517:06:25Statement of Changes in Beneficial Ownership (4)
06/05/201517:05:28Statement of Changes in Beneficial Ownership (4)
06/05/201517:04:36Statement of Changes in Beneficial Ownership (4)

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