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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; Tess.Stynes@dowjones.com

Stock News for Heartware International (HTWR)
DateTimeHeadline
04/22/201513:00:00HeartWare Schedules First Quarter 2015 Conference Call And Webcast
04/21/201517:30:51Statement of Changes in Beneficial Ownership (4)
04/20/201517:29:25Proxy Statement - Notice of Shareholders Meeting (preliminary...
04/20/201516:30:00Contemporary Results From Commercial HVAD® System Registries...
04/20/201513:32:05HeartWare International Given New $94.00 Price Target at Oppenheimer...
04/16/201509:02:31Current Report Filing (8-k)
04/16/201504:22:00HeartWare Achieves Primary Endpoint In The ENDURANCE Destination...
04/16/201504:20:00HeartWare Achieves Primary Endpoint In The ENDURANCE Destination...
04/10/201519:00:00HeartWare Announces Webcasts At The 35th International Society...
04/10/201506:27:00HeartWare international est autorisée par Santé Canada à commercialiser le...
04/09/201507:30:00HeartWare International Receives Health Canada Approval For Commercialization...
04/09/201507:30:00HeartWare International Receives Health Canada Approval For Commercialization...
04/02/201517:09:18Statement of Changes in Beneficial Ownership (4)
03/30/201517:16:10Statement of Changes in Beneficial Ownership (4)
03/04/201509:00:00HeartWare Presentation At The 2015 Barclays Global Healthcare...
03/04/201507:00:00Sunshine Heart: There Is A Silver Lining To Those Clouds
02/26/201507:18:03Current Report Filing (8-k)
02/26/201507:07:42Heartware beats by $0.18, beats on revenue
02/26/201507:00:00HeartWare International Reports $73.2 Million In Fourth Quarter...
02/25/201517:37:00HeartWare Presentation At The Raymond James 36th Annual Institutional...

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